Clinical trial NCT05966675: Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
Official title: Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrioventricular Block, Second and Third Degree
Keywords: Pacemaker
Transcatheter Aortic Valve Replacement
Conduction System Pacing (CSP)
Atrioventricular Block
Congestive Heart Failure
Bradycardia
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Medical Research Agency, Poland
First posted: 2023-08-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1 to the intervention and control groups. In the control group, the type of ventricular pacing will depend on the left ventricular ejection fraction (LVEF): 1) RVP is planned in the group of patients with LVEF ≥40%, 2) BVP is planned in the group of patients with LVEF \<40%, following current ESC guidelines.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Failure Hospitalization
timeFrame: 12 months
measure: All-cause death
timeFrame: 12 months
Secondary outcomes:
measure: Change in exercise capacity
timeFrame: 24 months
measure: Response to Cardiac Resynchronization Therapy (CRT)
timeFrame: 24 months
measure: Pacing-Induced Cardiomyopathy (PICM)
timeFrame: 24 months
measure: Change in global longitudinal strain (GLS)
timeFrame: 24 months
measure: Atrial Fibrillation (AF) episodes
timeFrame: 24 months
measure: Atrial High Rate Episodes (AHRE) in pacemaker recordings
timeFrame: 24 months
measure: Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP)
timeFrame: 24 months
measure: Change in Quality of Life
timeFrame: 24 months
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Medical University of Silesia in Katowice
Study officials:
affiliation: Silesian Medical University in Katowice
name: Krzysztof S. Gołba, MD PhD
role: STUDY_CHAIR
References:
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