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

Use our guide to learn which trials are right for you!

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.

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.

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
New York, New York 10003
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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4401 Penn Avenue
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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Pittsburgh, PA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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Birmingham, Alabama 35294
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Birmingham, AL
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Cincinnati, Ohio 45229
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Cincinnati, OH
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11100 Euclid Avenue
Cleveland, Ohio 44106
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Cleveland, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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1935 Medical District Drive
Dallas, Texas 75235
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Dallas, TX
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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Houston, Texas 77030
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Houston, TX
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Las Vegas, Nevada 89109
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Las Vegas, NV
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3100 Southwest 62nd Avenue
Miami, Florida 33155
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Miami, FL
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Newark, NJ
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Oak Lawn, Illinois 60453
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Oak Lawn, IL
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Sacramento, California 95816
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San Diego, California 92123
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Washington, D.C., District of Columbia
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