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Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

ConditionsTricuspid RegurgitationTricuspid Valve InsufficiencyTricuspid Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEdwards Lifesciences

About this trial

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eighteen (18) years of age or older

Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.

Severe or greater tricuspid regurgitation

New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months

Disqualifiers

Tricuspid valve anatomy not evaluable by TTE or TEE

Tricuspid valve anatomy precludes proper device deployment and function

Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure)

Would prevent proper TR reduction due to interaction of the lead with the leaflets

Trial design

Design model

Parallel

Treatments tested in this trial

  • Edwards PASCAL System

    Device

    Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy

  • Optimal Medical Therapy

    Drug

    Optimal Medical Therapy alone in patients with tricuspid regurgitation

  • Edwards PASCAL System

    Device

    Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT

  • Edwards PASCAL System

    Device

    Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Treatment groups

1,270 Participants
are divided into 4 treatment groups
Group A: Edwards PASCAL System & OMTExperimental treatment 1 intervention
Group B: Optimal Medical Therapy (OMT)Active comparator 1 intervention
Group C: Single-Arm RegistryExperimental treatment 1 intervention
Group D: Continued Access StudyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)

Comparison of number of participants with composite endpoint events between experimental and active comparator arms

Time frame
6 months

Secondary outcomes

1

1 Grade Reduction in TR Severity

Total number of participants with at least 1 grade reduction in TR severity

Time frame
6, 12 months
2

Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Change in KCCQ score from baseline

Time frame
3, 6, and 12 months
3

All Cause Mortality

Total number of deaths from any cause

Time frame
12 months, 24 months
4

Death and Heart Failure Hospitalizations

Total number of deaths and hospital admissions due to heart failure

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Edwards Lifesciences

Lead sponsor

Source ClinicalTrials.gov
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