PASCAL Precision-GDMT Registry

Official title

Improvement in Guideline-Directed Medical Therapy After Tricuspid Transcatheter Edge-to-Edge Repair in Participants With Reduced Left Ventricular Function

Overview

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.

Primary outcome measures

• Change in GDMT score at 12 months, compared to baseline [Time frame: From enrollment up to 12 months post-procedure]

Secondary outcome measures (5)

• Heart failure hospitalisation rate at 12 months [Time frame: From enrollment up to 12 months]
• All-cause hospitalisation rate at 12 months [Time frame: From enrollment up to 12 months]
• NT-pro BNP at 12 months compared to baseline [Time frame: At enrollment and at 12 months]
• New York Heart Association (NYHA) class at 12 months compared to baseline [Time frame: At enrollment and at baseline]
• Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months compared to baseline [Time frame: At enrollment and at 12 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Center list to be confirmed — check the primary 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 C PMID 40778456
• 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, Bo PMID 39602173
• 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. d PMID 36876753
• 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. 2 PMID 32241534
• 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
• 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
• 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 PMID 37365841
• 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

Identifiers

NCT: NCT07578129 · EDW-07

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗