Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:55 AM
Study NCT ID:
NCT07434193
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation
Sponsor:
Semmelweis University Heart and Vascular Center
Organization:
Study Overview
Official Title:
Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation- the BUDAPEST CRT TAVI Trial
Status:
RECRUITING
Status Verified Date:
2026-01
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:
BUDAPEST-TAVI
Brief Summary:
In this prospective, randomized, multicenter, open-label interventional clinical trial, the investigators' aim to test the effect of Cardiac Resynchronization Therapy (CRT) in cases of new-onset and persistent Left Bundle Branch Block (LBBB) occurring in the context of Transcatheter Aortic Valve Implantation (TAVI), in patients with moderately reduced left ventricular systolic function (35% \< EF \< 55%). The investigators hypothesize that in patients with persistent LBBB developing after TAVI and mildly reduced left ventricular systolic function (35% \< EF \< 55%), early postoperative CRT implantation favorably influences the process of myocardial reverse remodeling by reducing electromechanical dyssynchrony, thereby decreasing the combined endpoint of heart failure-related hospitalizations and mortality at one year.
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?: