Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System (TriCLASP)

July 15, 2026 updated by: Edwards Lifesciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • UKE Hamburg
      • Hamburg, Germany, 22087
        • Kath. Marienkrankenhaus Hamburg gGmbH
      • Lübeck, Germany
        • University Heart Center Lübeck
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie
      • Ulm, Baden-Wurttemberg, Germany, 89070
        • Universitätsklinikum Ulm Innere Medizin II
    • Bavaria
      • München, Bavaria, Germany, 81377
        • Medizinische Klinik I- Campus Grosshadern
    • DEU
      • Cologne, DEU, Germany, D-50937
        • Herzzentrum Universitätsklinikum Köln
    • Nordrhine Westfalia
      • Essen, Nordrhine Westfalia, Germany, 45147
        • Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
        • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Herzzentrum der Universitätsklinik Bonn
    • Saxony
      • Leipzig, Saxony, Germany, 04289
        • Heart Centre of the University Leipzig
    • Thuringia
      • Bad Berka, Thuringia, Germany, 99437
        • Zentralklinik Bad Berka GmbH
  • Greece
      • Athens, Greece, 151 23
        • Hygeia Hospital
  • Italy
      • Massa, Italy
        • Ospedale del Cuore "G. Pasquinucci"
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient tricuspid valve (TR ≥ 3+) by a Heart Team who assesses patient risk and anatomic suitability for the procedure.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
30 days
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.
Discharge: defined as discharge or 7 days post-procedure, whichever comes first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Volume overload assessed by serial measurements
Time Frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Patient edema questionnaire
baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements
Time Frame: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Body weight in kilogram
baseline, 30 days, 6 months, 12 months, annually up to 5 years
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
baseline, 30 days, 6 months, 12 months, annually up to 5 years
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
baseline, 30 days, 6 months, 12 months, annually up to 5 years
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
baseline, 30 days, 6 months, 12 months, annually up to 5 years
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
baseline, 30 days, 6 months, 12 months, annually up to 5 years
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
baseline, 30 days, 6 months, 12 months, annually up to 5 years
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
baseline, 30 days, 6 months, 12 months, annually up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephan Baldus, Prof. Dr., Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-11 (APHM)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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