Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation
• Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines
• Written informed consent
• Age of at least 18 years
Locations
Other Locations
Poland
Medical University of Silesia in Katowice
RECRUITING
Katowice
Contact Information
Primary
Krzysztof S. Gołba, MD PhD
krzysztof.golba@gmail.com
+48 (32)359-88-93
Backup
Tomasz Soral, MD
tomasz.soral@gmail.com
Time Frame
Start Date: 2024-02-27
Estimated Completion Date: 2028-06
Participants
Target number of participants: 500
Treatments
Experimental: Conduction System Pacing
Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.
Active_comparator: Standard Pacing Method
Patients who receive currently standard pacing method with exact type of ventricular pacing depending upon left ventricular ejection fraction (LVEF): right ventricular pacing in case of LVEF \>= 40% or biventricular pacing if LVEF is determined to be less than 40%, as per current ESC guidelines.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Silesia
Collaborators: Medical Research Agency, Poland