Tricuspid InsufficiencyPASCALNCT07578129
PASCAL Precision-GDMT Registry
An observational study of Tricuspid Insufficiency and Tricuspid Regurgitation (TR), run by Ceric Sàrl.
Trial summary
The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be associated with an improvement in up-titration of guideline-directed medical therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Insufficiency, Tricuspid Regurgitation (TR), Left Ventricular Cardiac Dysfunction
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Aug 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
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: Participants from France with at least severe tricuspid regurgitation with associated left ventricular dysfunction
Who may be able to join
- Participants of age ≥ 18 years
- ≥ severe tricuspid regurgitation
- LVEF < 50%
- Written informed consent of the patient or her/his legal representative
- Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up
- Planned follow-up within a dedicated heart failure clinic as part of routine care.
Who cannot join
- Anatomy unsuitable for TEER as determined by local heart team
- severe mitral regurgitation (defined as an EROA>40 mm2) treated (surgically or percutaneously) less than 3 months prior
- severe left ventricular dysfunction (defined as an LVEF <20%)
- systolic pulmonary artery pressure >70 mmHg (right heart catheterization)
- prior tricuspid valve intervention
- severe leaflet degeneration or tricuspid valve anatomy precluding successful device placement
Show all 14Show fewer
- primary tricuspid valve disease
- COPD requiring home oxygen therapy
- active endocarditis, or recent episode within 4 weeks of discontinuation of antibiotic therapy
- participants with unstable hemodynamic condition
- significant co-morbidities resulting in an expected less than 12-month life expectancy
- The presence of other anatomic or comorbid conditions or other medical, social or psychological conditions that in the investigators' opinion could limit the subject's ability to participate in the clinical study and its follow-up.
- Participants under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision
- Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improvement in Guideline-Directed Medical Therapy After Tricuspid Transcatheter Edge-to-Edge Repair in Participants With Reduced Left Ventricular Function
The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be associated with an improvement in up-titration of guideline-directed medical therapy (GDMT). The main question it aims to answer is:
Does the tricuspid insufficiency repair with the Pascal Precision System increases the dose of the medications used for heart failure therapy in the study population 12 months after tricuspid repair, as compared to the dose taken at baseline.
Participants undergoing tricuspid repair and fulfilling all inclusion/exclusion criteria will be asked to answer heart failure assessment as well as quality of life questionnaires at baseline and at 12 months post intervention. Medication monitoring will be performed throughout the study.
- Conditions
- Tricuspid Insufficiency, Tricuspid Regurgitation (TR), Left Ventricular Cardiac Dysfunction, Left Ventricular (LV) Systolic Dysfunction, Left Ventricular Dysfunction, Left Ventricular Ejection Fraction
- Keywords
- T-TEER, Severe Tricuspid regurgitation, left ventricular dysfunction, GDMT score, NHYA, KCCQ
- Medical subject headings
- Tricuspid Valve Insufficiency, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with at least severe tricuspid regurgitation and associated left ventricular dysfuntion | Participants of the cohort undergoing a successful T-TEER will be enrolled in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GDMT score at 12 months, compared to baseline
The GDMT score is calculated by adding all scores of each HF therapy. The minimum score corresponds to no medication taken and is 0. The maximum score is 11 and corresponds to all medications taken at the maximum dose. An intermediate score would be all medications taken at the intermediate dose and would be 6 (ACEi/ARB/ARNI = 2, BB = 2, MRA at 50-99% = 2). A low score would be ACEi/ARB/ARNI, BB and MRA at low dose and would be 3.
The dose of diuretics, although not included in the GDMT score, should be collected and considered separately.
Measured: From enrollment up to 12 months post-procedure
Secondary outcomes (5)
Heart failure hospitalisation rate at 12 months
Number of hospitalizations related to heart failure at 12 months divided by the number of patients
Measured: From enrollment up to 12 months
All-cause hospitalisation rate at 12 months
Number of hospitalisations for all cause at 12 months divided by the number of patients
Measured: From enrollment up to 12 months
NT-pro BNP at 12 months compared to baseline
Comparison of the 12-months level of NT-pro BNP to the baseline level of NT-pro BNP
Measured: At enrollment and at 12 months
New York Heart Association (NYHA) class at 12 months compared to baseline
Comparison of the NYHA class at 12 months with the NYHA class at baseline
Measured: At enrollment and at baseline
Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months compared to baseline
Comparison of the KCCQ score at 12 months with the KCCQ score at baseline
Measured: At enrollment and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Tricuspid InsufficiencyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thibault Lhermusier, MD, PhD, Principal investigator, CHU Rangueil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578129
- Sponsor's protocol ID
- EDW-07
- Acronym
- PASCAL
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan has been established in the protocol
Publications
Baldus S, Lapp H, Schofer N, Geisler T, Kister T, Ludike P, Rassaf T, Hausleiter J, Friedrichs K, Frerker C, Lubos E, Kessler M, Spargias K, Schmitz T, Nickenig G, Praz F, Berti S, Walther C, Mehrkens D, Goebel B, Kalbacher D, Zdanyte M, Roeder MV, Mahabadi A, Weckbach L, Ivannikova M, Marquetand C, Dotz I, Groger M, Chrissoheris M, Eissmann M, Vogelhuber J, Brugger N, D'Agostino A, Kroll M, Ren CB, Lurz P, Behalf Of The TriCLASP Study Investigators O. Transcatheter valve repair of tricuspid regurgitation: 1-year outcomes from the TriCLASP study. EuroIntervention. 2025 Aug 4;21(15):e869-e878. doi: 10.4244/EIJ-D-24-01174.
PubMed 40778456Donal E, Dreyfus J, Leurent G, Coisne A, Leroux PY, Ganivet A, Sportouch C, Lavie-Badie Y, Guerin P, Rouleau F, Diakov C, van der Heyden J, Lafitte S, Obadia JF, Nejjari M, Karam N, Bernard A, Neylon A, Pierrard R, Tchetche D, Ghostine S, Ducrocq G, Si Moussi T, Jeu A, Peltier M, Cosyns B, Le Dolley Y, Habib G, Auffret V, Le Ven F, Picard F, Piriou N, Laperche T, Galli E, Istratoaie S, Jouan J, Bonnet G, de Groote P, Anselmi A, Trochu JN, Oger E; Tri-Fr Investigators. Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial. JAMA. 2025 Jan 14;333(2):124-132. doi: 10.1001/jama.2024.21189.
PubMed 39602173Sorajja P, Whisenant B, Hamid N, Naik H, Makkar R, Tadros P, Price MJ, Singh G, Fam N, Kar S, Schwartz JG, Mehta S, Bae R, Sekaran N, Warner T, Makar M, Zorn G, Spinner EM, Trusty PM, Benza R, Jorde U, McCarthy P, Thourani V, Tang GHL, Hahn RT, Adams DH; TRILUMINATE Pivotal Investigators. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023 May 18;388(20):1833-1842. doi: 10.1056/NEJMoa2300525. Epub 2023 Mar 4.
PubMed 36876753Orban M, Rommel KP, Ho EC, Unterhuber M, Pozzoli A, Connelly KA, Deseive S, Besler C, Ong G, Braun D, Edwards J, Miura M, Gulmez G, Stolz L, Gavazzoni M, Zuber M, Orban M, Nabauer M, Maisano F, Thiele H, Massberg S, Taramasso M, Fam NP, Lurz P, Hausleiter J. Transcatheter Edge-to-Edge Tricuspid Repair for Severe Tricuspid Regurgitation Reduces Hospitalizations for Heart Failure. JACC Heart Fail. 2020 Apr;8(4):265-276. doi: 10.1016/j.jchf.2019.12.006.
PubMed 32241534Kresoja KP, Rommel KP, Thiele H, Lurz P. Ventricular Interaction in a Patient With Heart Failure With Preserved Ejection Fraction and Severe Tricuspid Regurgitation. Circ Heart Fail. 2021 Oct;14(10):e008768. doi: 10.1161/CIRCHEARTFAILURE.121.008768. Epub 2021 Sep 30. No abstract available.
PubMed 34665675Kingma I, Tyberg JV, Smith ER. Effects of diastolic transseptal pressure gradient on ventricular septal position and motion. Circulation. 1983 Dec;68(6):1304-14. doi: 10.1161/01.cir.68.6.1304.
PubMed 6640880Adamo M, Chioncel O, Benson L, Shahim B, Crespo-Leiro MG, Anker SD, Coats AJS, Filippatos G, Lainscak M, McDonagh T, Mebazaa A, Piepoli MF, Rosano GMC, Ruschitzka F, Savarese G, Seferovic P, Shahim A, Popescu BA, Iung B, Volterrani M, Maggioni AP, Metra M, Lund LH. Prevalence, clinical characteristics and outcomes of heart failure patients with or without isolated or combined mitral and tricuspid regurgitation: An analysis from the ESC-HFA Heart Failure Long-Term Registry. Eur J Heart Fail. 2023 Jul;25(7):1061-1071. doi: 10.1002/ejhf.2929. Epub 2023 Jun 26.
PubMed 37365841Topilsky Y, Nkomo VT, Vatury O, Michelena HI, Letourneau T, Suri RM, Pislaru S, Park S, Mahoney DW, Biner S, Enriquez-Sarano M. Clinical outcome of isolated tricuspid regurgitation. JACC Cardiovasc Imaging. 2014 Dec;7(12):1185-94. doi: 10.1016/j.jcmg.2014.07.018. Epub 2014 Nov 5.
PubMed 25440592Kresoja KP, Lauten A, Orban M, Rommel KP, Alushi B, Besler C, Braun D, Unterhuber M, Stangl K, Landmesser U, Massberg S, Thiele H, Hausleiter J, Lurz P. Transcatheter tricuspid valve repair in the setting of heart failure with preserved or reduced left ventricular ejection fraction. Eur J Heart Fail. 2020 Oct;22(10):1817-1825. doi: 10.1002/ejhf.1975. Epub 2020 Sep 2.
PubMed 32741057Santas E, Chorro FJ, Minana G, Mendez J, Munoz J, Escribano D, Garcia-Blas S, Valero E, Bodi V, Nunez E, Sanchis J, Nunez J. Tricuspid Regurgitation and Mortality Risk Across Left Ventricular Systolic Function in Acute Heart Failure. Circ J. 2015;79(7):1526-33. doi: 10.1253/circj.CJ-15-0129. Epub 2015 Apr 9.
PubMed 25854896Adamo M, Chioncel O, Pagnesi M, Bayes-Genis A, Abdelhamid M, Anker SD, Antohi EL, Badano L, Ben Gal T, Bohm M, Delgado V, Dreyfus J, Faletra FF, Farmakis D, Filippatos G, Grapsa J, Gustafsson F, Hausleiter J, Jaarsma T, Karam N, Lund L, Lurz P, Maisano F, Moura B, Mullens W, Praz F, Sannino A, Savarese G, Tocchetti CG, van Empel VPM, von Bardeleben RS, Yilmaz MB, Zamorano JL, Ponikowski P, Barbato E, Rosano GMC, Metra M. Epidemiology, pathophysiology, diagnosis and management of chronic right-sided heart failure and tricuspid regurgitation. A clinical consensus statement of the Heart Failure Association (HFA) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC. Eur J Heart Fail. 2024 Jan;26(1):18-33. doi: 10.1002/ejhf.3106. Epub 2024 Jan 14.
PubMed 38131233Kresoja KP, Adamo M, Rommel KP, Stolz L, Karam N, Giannini C, Melica B, von Bardeleben RS, Butter C, Horn P, Praz F, Kalbacher D, Iliadis C, Thiele H, Hausleiter J, Metra M, Lurz P. Guideline-directed medical therapy assessment in heart failure patients undergoing percutaneous mitral valve repair. ESC Heart Fail. 2024 Jun;11(3):1802-1807. doi: 10.1002/ehf2.14705. Epub 2024 Feb 13.
PubMed 38351672McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992