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NCT Number: NCT04614402

Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System

This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Tricuspid Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie, Tübingen, Baden-Wurttemberg, Germany

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About this study

The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team
  • TR grade ≥3+ (5 grade classification)
  • Patient is eligible to receive the PASCAL device per the current approved indications for use

Exclusion criteria

  • Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement
  • Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
  • Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
  • Any patient considered to be part of a vulnerable population

Treatment and study plan

Edwards PASCAL Transcatheter Valve Repair System

Device

The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.

Edwards PASCAL Precision Transcatheter Valve Repair System

Device

The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.

Primary outcomes

  1. Number of patients with major adverse events (MAE rates)

    Time frame: 30 days

    The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days

  2. Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography

    Time frame: Discharge: defined as discharge or 7 days post-procedure, whichever comes first

    Reduction in TR severity as assessed by TEE pre and post-implant in the procedure room. TR severity compared to baseline will be assessed by TR grade at each follow-up interval.

Secondary outcomes

  1. Volume overload assessed by serial measurements

    Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years

    Patient edema questionnaire

  2. Volume overload assessed by serial measurements

    Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years

    Body weight in kilogram

  3. Volume overload assessed by serial measurements

    Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years

    Edema Assessment (scale 1+ - 4+) grade correspond to mm

  4. Volume overload assessed by serial measurements

    Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years

    Ankle circumference measurement in cm

  5. Functional class, functional status, and Quality of life as assessed

    Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years

    NYHA classification (I-IV) grade

  6. Functional class, functional status, and Quality of life as assessed

    Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years

    6-Minute Walk Test in meter

  7. Functional class, functional status, and Quality of life as assessed

    Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years

    5 Level EQ 5D Questionnaire

  8. Functional class, functional status, and Quality of life as assessed

    Time frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years

    Kansas City Cardiomyopathy Questionnaire

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up

Acronym: TriCLASP

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Nov 4, 2020
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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