Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
Recruiting · NCT05966675 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
conduction system pacingright ventricular or biventricular pacing
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
- Predicted inability to obtain cooperation from patient during observation period
Where it is running
1 location listed.
- Medical University of Silesia in Katowice - Katowice, Poland