TRICuspid Intervention in Heart Failure Trial (TRICI-HF-DZHK24)

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Functional tricuspid regurgitation (TR) is a serious and progressive disease. Guidelines recommend surgical valve repair of severe TR in symptomatic patients. Despite its association with excess mortality and morbidity, TR has been relatively neglected and is severely undertreated. In particular this is because isolated tricuspid surgery remains associated with high mortality rates, and thus, patients with severe TR are often deemed inoperable due to severe co-morbidities and frailty. In recent years, percutaneous CE-mark approved techniques for transcatheter tricuspid valve treatment (TTVT) have emerged as alternatives to surgery. These include (I) transcatheter annuloplasty devices (Tricuspid Cardioband) and (II) transcatheter edge-to-edge repair (TriClip, PASCAL). Several non-randomized studies suggested improved functional outcomes after TTVT, however, to data there is no evidence from randomized controlled trials addressing the actual efficacy of TTVT. The TRICuspid Intervention in Heart Failure trial (TRICI-HF trial) will assess the concept that TTVT will translate into a reduced morbidity and mortality. Patients will be randomly assigned in a 2:1 fashion to TTVT plus OMT (Experimental group) or OMT alone (Control group). TRICI-HF is an industry-independent, investigator-initiated strategy study and investigators may choose any suitable CE-marked percutaneous system on-label for TTVT.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject is symptomatic due to severe TR despite being on stable OMT for at least 30 days based on judgment of the local heart team. Patients with reduced left ventricular ejection fraction (HFrEF) will likely constitute a minority among eligible patients with isolated severe tricuspid regurgitation (9,13). However, HFrEF patients enrolled into the trial need to be on stable guideline-directed medical therapy for at least 4 weeks..

• Subject is at intermediate or greater estimated risk of mortality with tricuspid valve surgery based on judgment of the local heart team

• New York Heart Association (NYHA) Functional Class II, III or IVa

• Femoral vein access and valve anatomy are determined to be feasible for interventional treatment (including sufficient quality of TTE and TEE imaging)

• Age ≥ 18 years at time of consent

• Subject must provide written informed consent prior to any trial related procedure

Locations
Other Locations
Germany
Herzzentrum Bad Krozingen
NOT_YET_RECRUITING
Bad Krozingen
Herz- und Diabeteszentrum Nordrhein-Westfalen
NOT_YET_RECRUITING
Bad Oeynhausen
Schüchtermann-Klinik
NOT_YET_RECRUITING
Bad Rothenfelde
Charité Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Deutsches Herzzentrum Berlin
NOT_YET_RECRUITING
Berlin
Universitätsklinikum Bonn
NOT_YET_RECRUITING
Bonn
Herzzentrum Uniklinik Köln
NOT_YET_RECRUITING
Cologne
St.-Johannes-Hospital Dortmund
NOT_YET_RECRUITING
Dortmund
Helios Klinikum Erfurt
NOT_YET_RECRUITING
Erfurt
Universitätsklinikum Essen
NOT_YET_RECRUITING
Essen
Universitätsklinikum Frankfurt
NOT_YET_RECRUITING
Frankfurt
Universitätsklinikum Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
Universitätsklinikum Giessen
NOT_YET_RECRUITING
Giessen
Herzzentrum Göttingen
NOT_YET_RECRUITING
Göttingen
Herzzentrum UKE
NOT_YET_RECRUITING
Hamburg
Katholisches Marienkrankenhaus Hamburg
RECRUITING
Hamburg
MVZ Prof. Mathey/Schofer
RECRUITING
Hamburg
Universitätsklinikum Jena
NOT_YET_RECRUITING
Jena
Universitätsklinikum Schleswig-Holstein
RECRUITING
Kiel
Herzentrum Leipzig
NOT_YET_RECRUITING
Leipzig
Universitätsmedizin Mainz
NOT_YET_RECRUITING
Mainz
LMU Klinikum
RECRUITING
München
Herzzentrum Siegburg
NOT_YET_RECRUITING
Siegburg
Contact Information
Primary
Joerg Hausleiter, MD
joerg.hausleiter@med.uni-muenchen.de
+4989440072361
Backup
Thomas Stocker, MD
thomas.stocker@med.uni-muenchen.de
+49894400712625
Time Frame
Start Date: 2022-02-25
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 360
Treatments
Experimental: Experimental intervention
Transcatheter tricuspid valve treatment (TTVT) plus optimal medical therapy (OMT)
No_intervention: Control intervention
OMT for severe tricuspid regurgitation in right-sided heart failure
Related Therapeutic Areas
Sponsors
Collaborators: Heart and Diabetes Center North Rhine-Westphalia, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), University of Leipzig, Heart Center Leipzig - University Hospital, University Medical Center Mainz
Leads: LMU Klinikum

This content was sourced from clinicaltrials.gov