COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02987387 |
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Recruitment Status :
Recruiting
First Posted : December 8, 2016
Last Update Posted : October 8, 2020
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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 |
|---|---|
| Pulmonary Valve Insufficiency Pulmonary Valve Stenosis Heart Defects, Congenital Congenital Abnormalities Cardiovascular Diseases Heart Diseases | Device: SAPIEN XT THV |
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 : | Observational |
| Estimated Enrollment : | 191 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | New Enrollment SAPIEN XT Post-Approval Study |
| Actual Study Start Date : | July 17, 2017 |
| Estimated Primary Completion Date : | July 2022 |
| Estimated Study Completion Date : | August 2027 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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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 |
| Sampling Method: | Non-Probability Sample |
Study Population
Pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention.
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: Edwards THV Clinical Affairs | (949) 250-2500 | THV_CT.gov@Edwards.com |
Locations
Show 20 study locations
Sponsors and Collaborators
Edwards Lifesciences
| Responsible Party: | Edwards Lifesciences |
| ClinicalTrials.gov Identifier: | NCT02987387 |
| Other Study ID Numbers: |
2015-10 |
| First Posted: | December 8, 2016 Key Record Dates |
| Last Update Posted: | October 8, 2020 |
| Last Verified: | September 2020 |
| 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 |
| 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 Cardiovascular Diseases Heart Diseases Heart Defects, Congenital Pulmonary Valve Stenosis Pulmonary Valve Insufficiency |
Congenital Abnormalities Cardiovascular Abnormalities Heart Valve Diseases Ventricular Outflow Obstruction Respiration Disorders Respiratory Tract Diseases |