PASCAL Precision-GDMT Registry

NCT07578129 | Not Yet Recruiting

• 1 other identifier: EDW-07
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 (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

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment up to 12 months post-procedure

Secondary Outcomes (5)

• Heart failure hospitalisation rate at 12 months

  From enrollment up to 12 months

• All-cause hospitalisation rate at 12 months

  From enrollment up to 12 months

• NT-pro BNP at 12 months compared to baseline

  At enrollment and at 12 months

• New York Heart Association (NYHA) class at 12 months compared to baseline

  At enrollment and at baseline

• Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months compared to baseline

  At enrollment and at 12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants from France with at least severe tricuspid regurgitation with associated left ventricular dysfunction

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ceric Sàrl: lead

Related Publications (13)

• 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.

  PMID: 40778456 BACKGROUND

• Donal 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.

  PMID: 39602173 BACKGROUND

• Sorajja 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.

  PMID: 36876753 BACKGROUND

• Orban 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.

  PMID: 32241534 BACKGROUND

• Kresoja 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.

  PMID: 34665675 BACKGROUND

• Kingma 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.

  PMID: 6640880 BACKGROUND

• Adamo 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.

  PMID: 37365841 BACKGROUND

• Topilsky 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.

  PMID: 25440592 BACKGROUND

• Kresoja 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.

  PMID: 32741057 BACKGROUND

• Santas 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.

  PMID: 25854896 BACKGROUND

• Adamo 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.

  PMID: 38131233 BACKGROUND

• Kresoja 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.

  PMID: 38351672 BACKGROUND

• McDonagh 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.

  PMID: 34447992 BACKGROUND

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Study Officials

• Thibault Lhermusier, MD, PhD

  CHU Rangueil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe LE ROUX, MSc

CONTACT

+33(0)760278098; cleroux@cerc-europe.org

Basile Gravez, PhD

CONTACT

+33(0)789452048; bgravez@cerc-europe.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share