Tricuspid Valve InsufficiencyTriCLASPNCT04614402
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
An observational study of Tricuspid Valve Insufficiency, run by Edwards Lifesciences at 15 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Insufficiency
- What is being tested?
- Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 15 Jan 2021to 15 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Germany12 sites
Zentralklinik Bad Berka GmbH
Bad Berka, Thuringia, 99437
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, 32545
Herzzentrum der Universitätsklinik Bonn
Bonn, North Rhine-Westphalia, 53127
Herzzentrum Universitätsklinikum Köln
Cologne, DEU, D-50937
Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie
Essen, Nordrhine Westfalia, 45147
UKE Hamburg
Hamburg, 20246
Kath. Marienkrankenhaus Hamburg gGmbH
Hamburg, 22087
Heart Centre of the University Leipzig
Leipzig, Saxony, 04289
University Heart Center Lübeck
Lübeck
Medizinische Klinik I- Campus Grosshadern
München, Bavaria, 81377
Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie
Tübingen, Baden-Wurttemberg, 72076
Universitätsklinikum Ulm Innere Medizin II
Ulm, Baden-Wurttemberg, 89070
About this study
Official title: 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.
Read the 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.
- Conditions
- Tricuspid Valve Insufficiency
- Being tested
- Edwards PASCAL Transcatheter Valve Repair System, Edwards PASCAL Precision Transcatheter Valve Repair System
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards PASCAL Transcatheter Valve Repair SystemDevice
The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
Edwards PASCAL Precision Transcatheter Valve Repair SystemDevice
The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with major adverse events (MAE rates)
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
Measured: 30 days
Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography
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.
Measured: Discharge: defined as discharge or 7 days post-procedure, whichever comes first
Secondary outcomes (8)
Volume overload assessed by serial measurements
Patient edema questionnaire
Measured: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements
Body weight in kilogram
Measured: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements
Edema Assessment (scale 1+ - 4+) grade correspond to mm
Measured: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Volume overload assessed by serial measurements
Ankle circumference measurement in cm
Measured: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed
NYHA classification (I-IV) grade
Measured: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed
6-Minute Walk Test in meter
Measured: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed
5 Level EQ 5D Questionnaire
Measured: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Functional class, functional status, and Quality of life as assessed
Kansas City Cardiomyopathy Questionnaire
Measured: baseline, 30 days, 6 months, 12 months, annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start15 Jan 2021
- Primary completion20 Apr 2023
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Baldus, Prof. Dr., Principal investigator, Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614402
- Sponsor's protocol ID
- 2019-11
- Acronym
- TriCLASP
- Status last verified
- Jul 2026
- First submitted
- 25 Sep 2020
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up
- ClinicalTrials.gov ID
- NCT04614402
- Acronym / sponsor ID
- TriCLASP / 2019-11
- Conditions
- Tricuspid Valve Insufficiency
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edwards PASCAL Transcatheter Valve Repair SystemThe Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve. | Device | – |
| Edwards PASCAL Precision Transcatheter Valve Repair SystemThe Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve. | Device | – |
Primary outcome
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
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.
8 secondary outcomes
Volume overload assessed by serial measurements
Time frame: 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
Volume overload assessed by serial measurements
Time frame: 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
Functional class, functional status, and Quality of life as assessed
Time frame: 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
Functional class, functional status, and Quality of life as assessed
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Baldus, Prof. Dr. principal investigator
Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Valve Insufficiency, run by Edwards Lifesciences at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Greece, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with major adverse events (MAE rates) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.