Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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Study Matches
AMPLATZER PFO Occluder Post Approval Study (PFO PAS)
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness
of the AMPLATZER™ PFO Occluder in the post Approval Setting.
Kurt Jacobson, MD, MHSA
All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03309332
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Inclusion Criteria:
• Subjects with a PFO who have had an ischemic stroke within the last 547 days
Exclusion Criteria:
• Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels
associated with a ≥ 50% lumen diameter supplying the involved lesion
• Intra-cardiac thrombus or tumor
• Documented evidence of venous thrombus in the vessels through which access to the PFO
is gained
• Acute or recent (within 6 months prior to consent) myocardial infarction or unstable
angina
• Left ventricular aneurysm or akinesis
• Mitral valve stenosis or severe mitral regurgitation requiring intervention
irrespective of etiology
• Aortic valve stenosis (mean gradient >40 mmHg) or severe aortic valve regurgitation
• Mitral or aortic valve vegetation or prosthesis
• Aortic arch plaques protruding greater than 4mm into the aortic lumen
• Left ventricular dilated cardiomyopathy with depressed left ventricular ejection
fraction (LVEF less than 35%)
• Subjects with other source of right to left shunts, including an atrial septal defect
and/or fenestrated septum
• Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
• Pregnancy at the time of implant
• Age less than 18 years or greater than 60 years at time of consent
• Active endocarditis or other untreated infections
• Organ failure (kidney, liver or lung) Kidney failure: Poor urine output of less than 1
cc/kg/hr with elevated BUN levels (above the normal reference range for the laboratory
at the investigational site).
Liver failure: Liver enzymes outside the normal reference range for the laboratory at the
investigational site: poor liver function as assessed by elevated PT (above the normal
reference range for the laboratory at the investigational site) and low total protein and
albumin (below the normal reference range for the laboratory at the investigational site).
Lung failure: Respiratory failure is retention of carbon dioxide more than 60 mmHg, poor
oxygenation with oxygen tension less than 40 mmHg in room air or the need for assisted
ventilation.
• Uncontrolled hypertension defined as sustained elevated systemic blood pressure to
more than 160/90 mmHg with medications
• Uncontrolled diabetes defined as continued elevated glucose levels in spite of
administration of insulin/levels of more than 200 mg with presence of glucose in the
urine
• Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying
stroke event Definition: Ischemic stroke in the distribution of a single, small deep
penetrating vessel in a patient with any of the following: 1) a history of
hypertension (except in the first week post stroke); 2) history of diabetes mellitus;
3) Age >/= 50; or 4) MRI or CT shows leukoaraiosis greater than symmetric,
well-defined periventricular caps or bands (European Task Force on Age-Related White
Matter Changes rating scale score > 0)
• Arterial dissection as cause of stroke
• Subjects who test positive with one of the following hypercoagulable states;
Anticardiolipin Ab of the IgG or IgM (≥30), Lupus anticoagulant, B2-glycoprotein-1
antibodies (≥30) or persistently elevated homocysteine (>20)
• Unable to take antiplatelet therapy
• Anatomy in which the AMPLATZERTM PFO Occluder device size required would interfere
with intracardiac or intravascular structures such as valves or pulmonary veins
• Vasculature, through which access to the PFO is gained, is inadequate to accommodate
the appropriate sheath size
• Malignancy or other illness where life expectancy is less than 2 years
• Subjects who will not be available for follow-up for the duration of the trial
• Inability to obtain Informed Consent from patient
• Index stroke of poor outcome (modified Rankin score greater than 3)
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left VentricularAssist System (COMPETENCE)
This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority
study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3
LVAS).
Yu Xia
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT01187368
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Inclusion Criteria:
The following is a list of general inclusion criteria:
• Age ≥ 18 years
• Left Ventricular Ejection Fraction (LVEF) < 30%
• NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure
• Inotrope dependent OR Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
• Patient is able to provide written informed consent
• More detailed inclusion criteria information is noted in the study protocol
Exclusion Criteria:
1. Etiology of heart failure due to or associated with uncorrected thyroid disease,
obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive
cardiomyopathy
2. Technical obstacles which pose an inordinately high surgical risk
3. Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella
5.0 or 5.5
4. Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and
elevated LDH equal or greater than 600 IU/L.
5. Positive pregnancy test if of childbearing potential
6. Presence of mechanical aortic cardiac valve that will not be either converted to a
bioprosthesis
7. History of any organ transplant
8. Platelet count <100,000/mL
9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial
issues
10. History of confirmed, untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter
within 6 months of enrollment
11. Presence of an active, uncontrolled infection
12. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative
therapy that the investigator will require based upon the patient's health status
13. Presence of remarkable pre-defined end-organ dysfunction.
14. Patient has moderate to severe aortic insufficiency without plans for correction
during pump implant
15. Low albumin •removed from recent exclusion criteria
16. Planned Bi-VAD support prior to enrollment
17. Patient has known hypo- or hyper coagulable state such as disseminated intravascular
coagulation and heparin induced thrombocytopenia (HIT)
18. Participation in any other clinical investigation that is likely to confound study
results or affect the study
19. Any condition other than heart failure that could limit survival to less than 24
months
20. Patients refusing blood transfusion
Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled,
double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham
treatment
Treatment Group:
Subjects treated with aBMC using the CardiAMP cell therapy system
Sham Control Group:
Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial
delivery catheter, no administration of aBMC)
Amish Raval, MD
All
21 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03455725
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Inclusion Criteria:
1. Male or female 21 to 80 years of age
2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina
drugs.
4. Evidence of inducible myocardial ischemia on baseline stress testing
5. Obstructive coronary disease unsuitable for conventional revascularization
6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week
screening period).
7. Able to complete an exercise tolerance test on the treadmill
8. Left ventricular ejection fraction of greater than or equal to 40% as measured by
echocardiography.
9. Qualification of a pre-procedure screening of bone-marrow aspiration
Exclusion Criteria
Other cardiac or vascular system or other health-related criteria which may be seen in a
patient's history and physical examination.
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
This is a randomized, double-blind, placebo controlled, multicenter study to compare the
efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for
congenital heart defects. Eligible patients undergoing repair of a large unrestrictive
ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD),
or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.
Petros Anagnostopoulos
All
up to 18 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05253209
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Inclusion Criteria:
• Patients, parents, or legal guardian willing and able to sign informed consent
• Male and female subjects aged ≤18 years of age (females of child-bearing potential
willing to practice an acceptable form of birth control)
• Patients undergoing cardiopulmonary bypass for repair of a large unrestrictive
ventricular septal defect, an ostium primum/secundum atrial septal defect, or a
partial or complete atrioventricular septal defect
• Pre-operative echocardiogram confirming cardiovascular anatomy and defect to be
repaired
Exclusion Criteria:
• Evidence of pulmonary artery or vein abnormalities that will not be addressed
surgically. Specific abnormalities excluded include:
• significant pulmonary artery narrowing not amenable to surgical correction
• previous pulmonary artery stent placement
• significant left sided AV valve regurgitation not amenable to surgical correction
• pulmonary venous return abnormalities not amenable to surgical correction
• pulmonary vein stenosis not amenable to surgical correction
• Preoperative requirement for mechanical ventilation or IV inotrope support
• Presence of fixed or idiopathic pulmonary hypertension (i.e. Eisenmenger's Syndrome)
prior to surgical repair
• Pre-operative use of medications to treat pulmonary hypertension
• Pregnancy; Sexually active females of child-bearing potential must be willing to
practice an acceptable method of birth control for the duration of study participation
(e.g. oral contraceptive, hormonal implant, intra-uterine device)
• Participation in another clinical trial within 30 days of Screening or while
participating in the current study, including the 28 days of follow-up post study drug
administration.
• Any condition which, in the opinion of the investigator, might interfere with the
study objectives
The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective,
multi-center, randomized, non-inferiority, controlled pivotal clinical trial to evaluate the
safety and efficacy of the ACCEL® Absorbable Hemostat Powder as compared to gelatin sponge,
for achieving hemostasis in subjects undergoing cardiovascular, liver, or soft tissue
surgery, when control of oozing to moderate bleeding by standard surgical techniques is
ineffective and/or impractical.
Chris Rokkas
All
22 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04728087
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Inclusion Criteria:
Pre-Surgery:
1. Subject is greater than or equal to 22 years old
2. Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical
procedure
3. Subject is willing and able to provide appropriate (Institutional Review Board (IRB)
approved) informed consent.
4. The subject is willing and able to comply with the requirements of the protocol,
including follow-up evaluations and schedule.
5. The subject is willing to be treated with ACCEL® Absorbable Hemostat Powder
6. The subject is willing to be treated with a commercially available absorbable gelatin
sponge
During Surgery:
7. Subject has not received blood transfusions between screening and application of
investigational product or commercially available absorbable gelatin sponge
8. There is an estimated TBS surface area of ≤ 60 cm2
9. Visual observation of oozing (0.01 g/10s ˂ Flow ˂ 0.04 g/10s), mild (0.04 g/10s ≤ Flow
˂ 0.32 g/10s), or moderate (0.32 g/10s ≤ Flow ˂ 1.01 g/10s) bleeding as validated and
when control by conventional surgical techniques, including but not limited to suture,
ligature and cautery, is ineffective and/or impractical
10. There is an absence of intra-operative complications other than bleeding, which, in
the opinion of the Investigator, may interfere with the assessment of efficacy or
safety
11. There has been no intra-operative use of adjunct hemostat(s) on the target bleeding
site identified for application of the study treatment
Exclusion Criteria:
Pre-Surgery:
1. The subject is pregnant (verified in a manner consistent with institution's standard
of care)
2. Subject is lactating
3. Subject is currently participating in another investigational device or drug trial or
has participated in one in the past 4 weeks (prior to surgery) or is planning to
participate in another research study involving any investigational product within 4
weeks after surgery
4. Subject is a prisoner, a minor or unable to adequately give informed consent due to
mental or physical condition
5. Subject has medical, social, or psychosocial issues that the Investigator believes
could impact the subject's safety or compliance with study procedures
6. Subject has a known allergy to potatoes
7. Subject has a known allergy to porcine collagen/gelatin
8. Subject has a religious or other objection to porcine products
9. Subject is unwilling to receive blood products
10. Subject has history of heparin-induced thrombocytopenia (only for cardiovascular
subjects where heparin use is required)
11. Subject with a baseline abnormality of INR > 2.5 or an aPTT> 100 seconds during
screening that is not explained by current drug treatment (e.g. heparin, warfarin,
etc.).
12. Subjects with platelets < 100 X 109 PLT/L during screening
13. Subject with Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) > 3 X
upper limit normal range during screening, except for subjects undergoing liver
resection surgery or with a diagnosis of liver metastases where there is no upper
limit normal for these analytes due to the nature of their disease
14. Subject is unwilling or unable to return for the required follow-up after surgery
During Surgery:
15. Subject has an operative bleeding site which the surgeon is unable or unwilling to
control with a hemostatic agent
16. Extracorporeal cardiopulmonary bypass circuits or blood salvage circuits are to be
used during or after identification of the TBS.
17. There has been intra-operative use of thrombin on the patient.
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of AtrialFibrillation (REACT-AF)
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE
design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct
Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing
Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial
Fibrillation (AF) and low-to-moderate stroke risk.
Jennifer Wright
All
22 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05836987
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Inclusion Criteria:
1. Male or female, 22-85 years of age.
2. English speaking participants*
3. Documented history of symptomatic or asymptomatic paroxysmal or persistent AF. The
duration of AF must have been > 30 seconds as documented by an external monitor or
present on 12-lead ECG.
4. CHA2DS2-VASC score of 1-4 without prior stroke or Transient Ischemic Attack (TIA)**
5. The participant is on a DOAC at the time of screening.
6. Willing and able to comply with the protocol, including:
• Possession of a smartwatch-compatible smartphone (iPhone that supports the latest
shipping iOS) with a cellular service plan
• Be willing to wear the Apple watch at least 14 hours a day
• Expected to be within cellular service range at least 80% of the time
7. Willing and able to discontinue DOAC
8. The participant is willing and able to provide informed consent.
Exclusion Criteria:
1. Valvular or permanent atrial fibrillation.
2. Current treatment with warfarin and unwilling or unable to take a DOAC.
3. The participant is a woman who is pregnant, nursing, or of child-bearing potential and
is not on birth control.
4. The participant is being treated with chronic aspirin, another anti-platelet agent, or
chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention
in patients with atrial fibrillation, primary prevention of cardiovascular events,
pain relief, fever, gout) and is unwilling or unable to discontinue use for the study
duration.
5. Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable
Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or
planned insertable cardiac monitor.
6. Any documented single AF episode lasting ≥ 1 hour on screening external cardiac
monitor of >=6 days duration.
7. Mechanical prosthetic valve(s) or severe valve disease.
8. Hypertrophic cardiomyopathy.
9. Participant needs Direct Oral Anticoagulation (DOAC) for reasons other than preventing
stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis
(DVT) or Pulmonary Embolism (PE)) or needs permanent Oral Anticoagulant (OAC) (i.e.,
congenital heart defects, prosthetic heart valve).
10. Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid
artery disease defined as stenosis > 75%) based on the investigator's discretion.
11. The participant is enrolled, has participated within the last 30 days, or is planning
to participate in a concurrent drug and/or device study during the course of this
clinical trial. Co-enrollment in concurrent trials is only allowed with documented
pre-approval from the study manager; there is no concern that co-enrollment could
confound the results of this trial.
12. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area
on the ipsilateral side that the AFSW may be worn.
13. The participant has a tremor on their ipsilateral side that the AFSW may be worn.
14. Any concomitant condition that, in the investigator's opinion, would not allow safe
participation in the study (e.g., drug addiction, alcohol abuse).
15. Known hypersensitivity or contraindication to direct oral anticoagulants.
16. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
17. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated
hyperthyroidism). AF ablation does not constitute reversible AF.
18. > 5% burden premature atrial or ventricular depolarizations on any given calendar day
on pre-enrollment cardiac monitoring.
19. History of atrial flutter that has not been treated with ablation (participants in
atrial flutter and have been ablated are eligible for enrollment).
20. Stage 4 or 5 chronic kidney disease.
21. Conditions associated with an increased risk of bleeding:
• Major surgery in the previous month
• Planned surgery or intervention in the next three months.
• History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic
intra-articular bleeding
• Gastrointestinal hemorrhage within the past year unless the cause has been
permanently eliminated (e.g., by surgery)
• Symptomatic or endoscopically documented gastroduodenal ulcer disease in the
previous 30 days
• Hemorrhagic disorder or bleeding diathesis
• Need for anticoagulant treatment for disorders other than AF
• Required use of non-aspirin antiplatelet agents (i.e., Plavix) at time of
enrollment
• Uncontrolled hypertension (Systolic Blood Pressure (SBP) >180 mmHg and/or
Diastolic Blood Pressure( DBP) >100 mmHg)
• Spanish-only speakers may be included in the future at select sites where
consent forms are appropriately translated.
• Congestive heart failure defined as: The presence of signs and symptoms
of either right (elevated central venous pressure, hepatomegaly,
dependent edema) or left ventricular failure (exertional dyspnea,
cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac
enlargement, rales, gallop rhythm, pulmonary venous congestion) or
both, confirmed by non-invasive or invasive measurements demonstrating
objective evidence of cardiac dysfunction and/or ejection fraction <
40%
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