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TRICuspid Intervention in Heart Failure Trial

NCT04634266 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-22

No results posted yet for this study

Summary

Aims: Tricuspid regurgitation (TR) is a detrimental disease frequently diagnosed in patients with right-sided heart failure (HF). While transcatheter tricuspid valve interventions (TTVI) effectively reduce TR and improve quality of life (QoL) in earlier stages of the disease, their effect on reducing HF hospitalizations (HFH) and improving survival remains unclear.

Methods: TRIC-I-HF-DZHK24 is an investigator-initiated, prospective, randomized, open-label, multi-center strategy trial. Approximately 360 patients with severe TR and manifest right-sided HF will be enrolled. In contrast to previous trials, subjects with increased risk for HFH will be selected as facilitated by specific inclusion criteria: HFH in the previous year, or presence of cardio-renal syndrome, or evidence for cardio-hepatic syndrome. Subjects will be randomized 2:1 to TTVI and optimal medical therapy (OMT) or continuation of OMT alone. All CE-marked transcatheter repair devices including tricuspid transcatheter edge-to-edge repair (T-TEER) or transcatheter tricuspid annuloplasty can be used for TTVI. The participating 29 study sites are highly experienced in T-TEER. The primary outcome will be assessed at one year. First, a composite of all-cause mortality, HFH, and QoL improvement will be tested hierarchically. If positive, the combination of hard clinical endpoints including all-cause mortality and HFH will be tested. Patients will be followed for a total of 3 years. The safety outcome comprises complications of TTVI, life threatening bleeding and death.

Conclusions: The TRIC-I-HF-DZHK24 trial will define the role of TTVI in patients with severe TR and right-sided HF.

Conditions

  • Heart Failure Attributable to Severe Tricuspid Regurgitation

Interventions

DEVICE

Transcatheter tricuspid valve treatment (TTVT)

Percutaneous CE-mark approved techniques for transcatheter tricuspid valve treatment (TTVT): These include (I) transcatheter annuloplasty devices (Tricuspid Cardioband) and (II) transcatheter edge-to-edge repair (TriClip, PASCAL).

Sponsors & Collaborators

  • Heart and Diabetes Center North Rhine-Westphalia

    collaborator OTHER

  • University Medical Center Mainz

    collaborator OTHER

  • Heart Center Leipzig - University Hospital

    collaborator OTHER

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • LMU Klinikum

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2026-07-01
Completion
2028-10-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04634266 on ClinicalTrials.gov