Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-25 @ 10:56 AM
Study NCT ID:
NCT04634266
Status:
RECRUITING
Last Update Posted:
2022-08-23
First Post:
2020-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRICuspid Intervention in Heart Failure Trial
Sponsor:
LMU Klinikum
Organization:
Study Overview
Official Title:
TRICuspid Intervention in Heart Failure Trial (TRICI-HF-DZHK24)
Status:
RECRUITING
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRICI-HF
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TRICI-HF-DZHK24 | OTHER_GRANT | Deutsches Zentrum für Herzkreislaufforschung | View |