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 |
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Recruitment Status :
Recruiting
First Posted : December 8, 2016
Last Update Posted : June 25, 2019
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Sponsor:
Edwards Lifesciences
Information provided by (Responsible Party):
Edwards Lifesciences
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: TPVI
Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV
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Device: SAPIEN XT THV
SAPIEN XT THV will be implanted in the pulmonic position. |
Primary Outcome Measures :
- Freedom from device- or procedure-related death or reintervention [ Time Frame: 1 year ]
Secondary Outcome Measures :
- Decrease in pulmonary regurgitation to mild or less for regurgitant lesions [ Time Frame: 1 year ]Assessed via transthoracic echocardiogram (TTE)
- Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions [ Time Frame: 1 year ]Assessed via TTE
- 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.
Information from the National Library of Medicine
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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:
- Patient has a dysfunctional, non-compliant RVOT conduit.
- 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:
- Inability to tolerate an anticoagulation/antiplatelet regimen
- 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
| 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
| 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
| 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 |
| 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:
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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 |