Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Heart Failure Hospitalization
Study Overview
Brief 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).
Detailed Description
A multicenter randomized controlled head-to-head trial was planned to compare the effects of permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently standard therapy - RVP or BVP (control group). The study population will consist of patients hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI within 30 days after surgery, following the 2021 European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
Patient will be blind to type of intervention. Due to a need of method-specific use of hardware and tailored programming of cardiac devices, medical staff is impossible to blind. The inability to blind affects also echocardiographists and anyone performing device interrogation as significant differences in number and localisation of pacing leads, their electrical parameters and pacemaker settings are inherently different in studied arms.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conduction System Pacing
Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.
Intervention: conduction system pacing (Device)
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.
Intervention: right ventricular or biventricular pacing (Device)
Outcomes
Primary Outcomes
Heart Failure Hospitalization
Time Frame: 12 months
Hospitalization due to heart failure as a main reason
All-cause death
Time Frame: 12 months
Death from any cause
Secondary Outcomes
- Pacing-Induced Cardiomyopathy (PICM)(24 months)
- Change in global longitudinal strain (GLS)(24 months)
- Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP)(24 months)
- Change in Quality of Life(24 months)
- Atrial Fibrillation (AF) episodes(24 months)
- Change in exercise capacity(24 months)
- Response to Cardiac Resynchronization Therapy (CRT)(24 months)
- Atrial High Rate Episodes (AHRE) in pacemaker recordings(24 months)