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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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

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

• Age over 18 years

• Successful and complication-free TAVI implantation for significant aortic stenosis

• Signed informed consent after detailed patient information

• New-onset LBBB wider than 130 ms after TAVI, persisting at the time of planned discharge (assessed postoperatively on or after day 5)(21)

• Mildly reduced left ventricular systolic function on echocardiography at the planned time of discharge (at the earliest on postoperative day 5), with EF between 35% and 55%

Locations
Other Locations
Hungary
Semmelweis University, Heart and Vascular Center
RECRUITING
Budapest
Contact Information
Primary
Mihály Ruppert
merkely.study@gmail.com
+3614586810
Backup
Annamaria Kosztin
kosztin.annamaria@semmelweis.hu
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2033-01-31
Participants
Target number of participants: 360
Treatments
Active_comparator: CRT
CRT implantation
No_intervention: Standard of Care
Sponsors
Leads: Semmelweis University Heart and Vascular Center

This content was sourced from clinicaltrials.gov