Semmelweis University, Heart and Vascular Center
Budapest, 1122, Hungary
Location status: Recruiting
Location contact
Annamaria Kosztin, MD, PhD
CONTACT
Béla Merkely, Professor
PRINCIPAL_INVESTIGATOR
Mihály Ruppert, MD, PhD
CONTACT
NCT Number: NCT07434193
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Budapest, 1122, Hungary
Location status: Recruiting
Annamaria Kosztin, MD, PhD
CONTACT
Béla Merkely, Professor
PRINCIPAL_INVESTIGATOR
Mihály Ruppert, MD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CRT implantation in patients with LVEF between 35-55% and new-onset LBBB wider than 130 ms after TAVI implantation
Time frame: 12 months
Elapsed time to heart failure hospitalisation or all-cause mortality
Contact information is provided by the study sponsor or research team.
Semmelweis University Heart and Vascular Center
Other
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
Acronym: BUDAPEST-TAVI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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