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

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
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : October 8, 2020
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
Pulmonary Valve Insufficiency Pulmonary Valve Stenosis Heart Defects, Congenital Congenital Abnormalities Cardiovascular Diseases Heart Diseases Device: SAPIEN XT THV

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 : 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


Group/Cohort Intervention/treatment
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
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:

  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: Edwards THV Clinical Affairs (949) 250-2500 THV_CT.gov@Edwards.com

Locations
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Sponsors and Collaborators
Edwards Lifesciences
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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

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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:
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