Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI (PACE-4-TAVI)

Medical University of Silesia

Status: Enrolling

Conditions: Atrioventricular Block, Second and Third Degree

Treatments: Device: right ventricular or biventricular pacing; Device: conduction system pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT05966675

2022/ABM/03/00049

Details and patient eligibility

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).

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation
2. Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines
3. Written informed consent
4. Age of at least 18 years

Exclusion criteria

1. Permanent pacemaker implantation before TAVI procedure
2. The occurrence of conduction disturbances more than 30 days after TAVI procedure
3. No written informed consent
4. Inability to obtain informed consent from participant
5. Predicted inability to obtain cooperation from patient during observation period

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Conduction System Pacing

Experimental group

Description:

Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.

Treatment:

Device: conduction system pacing

Standard Pacing Method

Active Comparator group

Description:

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.

Treatment:

Device: right ventricular or biventricular pacing