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
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...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
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....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
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...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
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...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
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....
?
mi
from
Boston, MA
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
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...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1935 Medical District Drive
Dallas, Texas 75235
?
mi
from
Dallas, TX
Click here to add this to my saved trials
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...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Las Vegas, Nevada 89109
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
3100 Southwest 62nd Avenue
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
New York, New York 10003
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Oak Lawn, Illinois 60453
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
Sacramento, California 95816
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Washington, D.C., District of Columbia
?
mi
from
Washington, D.C.,
Click here to add this to my saved trials