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

Study design and study aims:

TRIC-I-HF-DZHK24 (TRICuspid Intervention in Heart Failure) is an investigator-initiated, prospective, nationwide, multi-center, randomized, controlled, open label strategy trial in patients with TR and significant right-sided HF. The trial is conducted in 29 German high-volume heart valve centers and will assess whether OMT plus transcatheter tricuspid valve repair in HF patients with severe TR is more effective than OMT alone. TRIC-I-HF-DZHK24 will assess the strategy of TTVI using the individual optimal CE-marked repair device. The optimal TTVI device for the individual patient is determined by the local heart team. TTVI repair devices studied in the trial include devices for T-TEER and transcatheter tricuspid annuloplasty. Patients deemed for tricuspid valve replacement (orthotopic or heterotopic) are excluded from this trial. TRIC-I-HF-DZHK24 will specifically enroll patients with signs of manifest HF to test the impact of TTVI on mortality and HFH in a vulnerable patient cohort with an increased risk for decompensation of HF. Previous randomized-controlled trials enrolled patients without criteria for manifest right-sided HF and observed comparably low event rates for HFH and mortality.

TRIC-I-HF-DZHK24 is funded by the German Center for Cardiovascular Research (DZHK) and co-funded by the university hospital of Ludwig-Maximilians-University, Munich, Germany, and Edwards Lifesciences. An executive steering committee composed of a group of experienced cardiologists in the treatment of HF and TR supports the design and conduct of the study. The industry sponsor is not involved in trial design or conduct and has no direct access to data during the course of the trial. A Data and Safety Monitoring Board will periodically review trial progress and evaluate the accumulated study data for participant safety. An independent Clinical Event Committee will independently adjudicate all hospitalizations. The trial is supported by the Münchner Studienzentrum (MSZ, TUM School of Medicine and Health in Munich) serving as central research organization. The trial is conducted in accordance with Good Clinical Practice, and ethical principles consistent with the Declaration of Helsinki. TRIC-I-HF-DZHK24 has received approval from the responsible local ethics committees prior to inclusion of patients.

Intervention scheme and trial flow:

HF patients with underlying severe TR are screened for eligibility. If all inclusion criteria and none of the exclusion criteria are met and the subject is willing to participate, informed consent for study participation is obtained. Further baseline examination is performed. Randomization will be performed online using pre-defined randomization lists with a 2:1 allocation ratio in favor of the interventional arm. Randomization is stratified by study center and by TR grade. To assure balanced group sizes a block-wise randomization is applied. If a participant is randomized into the control arm, OMT is continued at discharge and follow-up dates are scheduled. In the event of randomization into the interventional arm, TTVI should be scheduled as soon as possible within 14 days after randomization.