- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07578129
PASCAL Precision-GDMT Registry (PASCAL)
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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Christophe LE ROUX, MSc
- 전화번호: +33(0)760278098
- 이메일: cleroux@cerc-europe.org
연구 연락처 백업
- 이름: Basile Gravez, PhD
- 전화번호: +33(0)789452048
- 이메일: bgravez@cerc-europe.org
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in GDMT score at 12 months, compared to baseline
기간: From enrollment up to 12 months post-procedure
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Heart failure hospitalisation rate at 12 months
기간: From enrollment up to 12 months
|
Number of hospitalizations related to heart failure at 12 months divided by the number of patients
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From enrollment up to 12 months
|
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All-cause hospitalisation rate at 12 months
기간: From enrollment up to 12 months
|
Number of hospitalisations for all cause at 12 months divided by the number of patients
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From enrollment up to 12 months
|
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NT-pro BNP at 12 months compared to baseline
기간: At enrollment and at 12 months
|
Comparison of the 12-months level of NT-pro BNP to the baseline level of NT-pro BNP
|
At enrollment and at 12 months
|
|
New York Heart Association (NYHA) class at 12 months compared to baseline
기간: At enrollment and at baseline
|
Comparison of the NYHA class at 12 months with the NYHA class at baseline
|
At enrollment and at baseline
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months compared to baseline
기간: At enrollment and at 12 months
|
Comparison of the KCCQ score at 12 months with the KCCQ score at baseline
|
At enrollment and at 12 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Thibault Lhermusier, MD, PhD, CHU Rangueil
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- EDW-07
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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