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

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ClinicalTrials.gov Identifier: NCT04614402
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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

Condition or disease Intervention/treatment
Tricuspid Valve Insufficiency Device: Edwards PASCAL Transcatheter Valve Repair System

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

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : March 15, 2023
Estimated Study Completion Date : March 15, 2028

Intervention Details:
  • Device: Edwards PASCAL Transcatheter Valve Repair System
    The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

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): NCT04614402


Contacts
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Contact: TMTT Clinical Affairs +1 (949) 250 ext 2500 TMTT_Clinical@edwards.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Stephan Baldus, Prof. Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04614402    
Other Study ID Numbers: 2019-11
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases