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.
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)
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.
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