Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI

Medical University of Silesia500 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

500

Conditions

Atrioventricular Block, Second and Third Degree

Interventions

conduction system pacingDEVICE

Implantation of cardiac implantable electronic device (CIED) with conduction system pacing (left bundle branch area pacing or his bundle pacing).

right ventricular or biventricular pacingDEVICE

Implantation of cardiac implantable electronic device with right ventricular or biventricular pacing according to left ventricular ejection fraction and current ESC guidelines.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Silesia in Katowice

Katowice, Poland

RECRUITING

Outcomes

Primary Outcomes

Heart Failure Hospitalization

Hospitalization due to heart failure as a main reason

Time frame: 12 months

All-cause death

Death from any cause

Time frame: 12 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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%

Time frame: 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%.

Time frame: 24 months

Atrial Fibrillation (AF) episodes

Occurrence of the first episode of AF in a patient with no previous history of atrial fibrillation (AF).

Time frame: 24 months

Central Contacts

Krzysztof S. Gołba, MD PhD

CONTACT

+48 (32)359-88-93 krzysztof.golba@gmail.com

Tomasz Soral, MD

CONTACT

tomasz.soral@gmail.com

Data from ClinicalTrials.gov

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