Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation

Conditions
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Atrioventricular Block, Second and Third Degree

Intervention / Treatment
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* Device: conduction system pacing
* Device: right ventricular or biventricular pacing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conduction System Pacing<br>Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing. | Device: conduction system pacing<br>* Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).<br>|
| Active Comparator: Standard Pacing Method<br>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. | Device: right ventricular or biventricular pacing<br>* Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Hospitalization | Hospitalization due to heart failure as a main reason | 12 months | 
| All-cause death | Death from any cause | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise capacity | Improvement or deterioration in exercise capacity assessed as a change of ≥1 New York Heart Association (NYHA) functional class or a change in 6-Minute Walk Test (6MWT) distance by 55m or more | 24 months | 
| Response to Cardiac Resynchronization Therapy (CRT) | Meeting the echocardiographic criteria of response to CRT defined as a decrease in Left Ventricular End Systolic Volume by ≥15% or an increase in Left Ventricular Ejection Fraction by ≥5% from the baseline values | 24 months | 
| Pacing-Induced Cardiomyopathy (PICM) | Pacing-related CHF meeting the echocardiographic criteria of PICM defined as a decrease in LVEF by >=10% to the absolute value of <50% | 24 months | 
| Change in global longitudinal strain (GLS) | An increase in GLS value of 20 absolute percentage points from baseline or an increase above -16%. | 24 months | 
| Atrial Fibrillation (AF) episodes | Occurrence of the first episode of AF in a patient with no previous history of atrial fibrillation (AF). | 24 months | 
| Atrial High Rate Episodes (AHRE) in pacemaker recordings | Occurrence or change of the burden of AHRE events in the records from the CIED. | 24 months | 
| Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP) | pl/mL | 24 months | 
| Change in Quality of Life | Assessed with Short Form Health Survey (SF-36): 0 to 100; low QoL to high QoL - better outcome. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker, Transcatheter Aortic Valve Replacement, Conduction System Pacing (CSP), Atrioventricular Block, Congestive Heart Failure, Bradycardia