Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Silesia
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Permanent pacemaker implantation before TAVI procedure
The occurrence of conduction disturbances more than 30 days after TAVI procedure
No written informed consent
Inability to obtain informed consent from participant
Trial design
Treatments tested in this trial
- conduction system pacing
- right ventricular or biventricular pacing
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Medical University of Silesia
Lead sponsor
Medical Research Agency, Poland
Collaborator
Source ClinicalTrials.gov