COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
Status: | Recruiting |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Women's Studies, Pulmonary |
Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases, Reproductive |
Healthy: | No |
Age Range: | 19 - Any |
Updated: | 10/20/2017 |
Start Date: | July 17, 2017 |
End Date: | January 2024 |
Contact: | Erika Tequia |
Email: | Erika_Tequia@Edwards.com |
Phone: | 949-756-4652 |
New Enrollment SAPIEN XT Post-Approval Study
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT
Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular
outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market
setting.
Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular
outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market
setting.
The study is a prospective, non-randomized, multi-center clinical study to assess the safety
and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional
RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by
transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of
≥ 35 mmHg by TTE.
and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional
RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by
transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of
≥ 35 mmHg by TTE.
Inclusion Criteria:
1. Patient has a dysfunctional, non-compliant RVOT conduit.
2. The patient/patient's legally authorized representative has been informed of the
nature of the study, agrees to its provisions and has provided written informed
consent.
Exclusion Criteria:
1. Inability to tolerate an anticoagulation/antiplatelet regimen
2. Active bacterial endocarditis
We found this trial at
20
sites
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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