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COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction

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ClinicalTrials.gov Identifier: NCT02987387
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Valve Insufficiency Pulmonary Valve Stenosis Heart Defects, Congenital Congenital Abnormalities Cardiovascular Diseases Heart Diseases Device: SAPIEN XT THV Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 191 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Enrollment SAPIEN XT Post-Approval Study
Actual Study Start Date : July 17, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2024


Arm Intervention/treatment
Experimental: TPVI
Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV
Device: SAPIEN XT THV
SAPIEN XT THV will be implanted in the pulmonic position.




Primary Outcome Measures :
  1. Freedom from device- or procedure-related death or reintervention [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Decrease in pulmonary regurgitation to mild or less for regurgitant lesions [ Time Frame: 1 year ]
    Assessed via transthoracic echocardiogram (TTE)

  2. Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions [ Time Frame: 1 year ]
    Assessed via TTE

  3. Device Success [ Time Frame: 48 Hours Prior to Discharge ]

    Device Success is a composite of:

    • Deployment of the valve to the target area, and
    • Removal of the delivery catheter out of the body, and
    • Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987387


Contacts
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Contact: Veronica Pettigrew, RN 949-250-4116 Veronica_Pettigrew@Edwards.com
Contact: John Tejeda, MPAS,D.H.A. 949-250-6504 John_Tejeda@Edwards.com

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
United States, California
Sutter Medical Center Withdrawn
Sacramento, California, United States, 95919
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Nicklaus Children's Recruiting
Miami, Florida, United States, 33155
United States, Illinois
Advocate Children's Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
United States, Iowa
The University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Boston Children's Hospital Withdrawn
Boston, Massachusetts, United States, 02115
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
United States, Nevada
Children's Heart Center Nevada Recruiting
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
United States, New York
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
UH Rainbow Babies&Children's Withdrawn
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Children's Health Dallas Recruiting
Dallas, Texas, United States, 75235
Texas Children's Withdrawn
Houston, Texas, United States, 77030
Sponsors and Collaborators
Edwards Lifesciences

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02987387     History of Changes
Other Study ID Numbers: 2015-10
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Edwards Lifesciences:
Tetralogy of Fallot
Aortic Valve Defect/Disease Resulting in Ross Procedure
Transcatheter pulmonary valve implantation
Transcatheter pulmonary valve replacement
Pulmonary Atresia
Pulmonary Stenosis
Additional relevant MeSH terms:
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Respiratory Insufficiency
Heart Diseases
Heart Defects, Congenital
Pulmonary Valve Stenosis
Pulmonary Valve Insufficiency
Congenital Abnormalities
Cardiovascular Diseases
Cardiovascular Abnormalities
Heart Valve Diseases
Ventricular Outflow Obstruction
Respiration Disorders
Respiratory Tract Diseases