Tricuspid RegurgitationNCT07859709
The CLASP III TR CED Study
An observational study of Tricuspid Regurgitation and Heart Valve Diseases, run by Edwards Lifesciences at 1 site in United States.
Trial summary
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the PASCAL Precision system. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases
- What is being tested?
- PASCAL Precision system Treated and Medicare Eligible Untreated Patients
- Type of treatment
- Medical device
- How many people
- 2,350 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 31 Oct 2033
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Medicare eligible real-world patients with severe tricuspid regurgitation
Who may be able to join
- Medicare eligible patients, 65 years old or older
- With at least severe Tricuspid Regurgitation who have either received PASCAL Precision system or been managed medically with no transcatheter or surgical tricuspid valve intervention
Who cannot join
- Patients not eligible for Medicare (i.e., under 65 years old)
- Patients with less than severe Tricuspid Regurgitation
- Patients who have received a transcatheter or surgical intervention other than PASCAL Precision system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Edwards Lifesciences
Irvine, California, 92614
TMTT GHER, 949-250-2500, TMTT_GHER_EVIDENCE@edwards.com
About this study
Official title: Edwards PASCAL Transcatheter Tricuspid Valve Repair System Coverage With Evidence Development Study (The CLASP III TR CED Study)
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the PASCAL Precision system.
Read the detailed description
This is a prospectively designed, retrospective non-randomized cohort study to measure the 2-year effectiveness of the PASCAL Precision Transcatheter Valve Repair system ("PASCAL Precision system") for the treatment of at least severe tricuspid regurgitation in the real world.
This study will evaluate patients treated with the PASCAL Precision system who have at least severe Tricuspid Regurgitation as compared to Medicare eligible untreated patients. Analysis will be completed using a large, de-identified, claims and electronic health record (EHR) database and supplemented with registry and other claims data.
The primary outcome will also be assessed in various pre-defined subgroups.
- Conditions
- Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Insufficiency
- Being tested
- PASCAL Precision system Treated, Medicare Eligible Untreated Patients
- Keywords
- PASCAL, Coverage with Evidence Development, CED
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASCAL Precision system TreatedDevice
Patients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system.
Medicare Eligible Untreated PatientsOther
Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention.
| Study group | Role | What they receive |
|---|---|---|
| PASCAL Precision system Treated | Patients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system. Receives: Device: PASCAL Precision system Treated | |
| Medicare Eligible Untreated Patients | Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention. Receives: Other: Medicare Eligible Untreated Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite (All-Cause Death or Heart Failure Hospitalization)
Time to death or heart failure hospitalization after time zero
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies 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
- Retrospective
- Enrolment
- 2,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859709
- Sponsor's protocol ID
- CLASP III TR
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edwards PASCAL Transcatheter Tricuspid Valve Repair System Coverage With Evidence Development Study (The CLASP III TR CED Study)
- ClinicalTrials.gov ID
- NCT07859709
- Acronym / sponsor ID
- CLASP III TR
- Conditions
- Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Insufficiency
- Keywords
- PASCAL, Coverage with Evidence Development, CED
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,350 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Oct 2033 (estimated)
- First posted
- 6 Oct 2026 (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 Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the PASCAL Precision system.
Detailed description
This is a prospectively designed, retrospective non-randomized cohort study to measure the 2-year effectiveness of the PASCAL Precision Transcatheter Valve Repair system ("PASCAL Precision system") for the treatment of at least severe tricuspid regurgitation in the real world.
This study will evaluate patients treated with the PASCAL Precision system who have at least severe Tricuspid Regurgitation as compared to Medicare eligible untreated patients. Analysis will be completed using a large, de-identified, claims and electronic health record (EHR) database and supplemented with registry and other claims data.
The primary outcome will also be assessed in various pre-defined subgroups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PASCAL Precision system Treated | – | Device: PASCAL Precision system TreatedPatients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system. |
| Medicare Eligible Untreated Patients | – | Other: Medicare Eligible Untreated PatientsPatients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Medicare eligible real-world patients with severe tricuspid regurgitation
Key inclusion criteria (2 listed)
- Medicare eligible patients, 65 years old or older
- With at least severe Tricuspid Regurgitation who have either received PASCAL Precision system or been managed medically with no transcatheter or surgical tricuspid valve intervention
Key exclusion criteria (3 listed)
- Patients not eligible for Medicare (i.e., under 65 years old)
- Patients with less than severe Tricuspid Regurgitation
- Patients who have received a transcatheter or surgical intervention other than PASCAL Precision system
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 |
|---|---|---|
| PASCAL Precision system TreatedPatients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system. | Device | PASCAL Precision system Treated |
| Medicare Eligible Untreated PatientsPatients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention. | Other | Medicare Eligible Untreated Patients |
Primary outcome
Composite (All-Cause Death or Heart Failure Hospitalization)
Time frame: 2 years
Time to death or heart failure hospitalization after time zero
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 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Tricuspid Regurgitation
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The TRICURE US IDE Pivotal Study
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Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation and Heart Valve Diseases, run by Edwards Lifesciences at 1 site in United States.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Contact TMTT GHER (949-250-2500, TMTT_GHER_Evidence@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite (All-Cause Death or Heart Failure Hospitalization) (time frame: 2 years). 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 6 Oct 2026.