Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI

Not Applicable

Not yet recruiting

• Conditions: Atrioventricular Block, Second and Third Degree
• Interventions: Device: conduction system pacing; Device: right ventricular or biventricular pacing

• Registration Number: NCT05966675
• Lead Sponsor: Medical University of Silesia

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 Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-08-01
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-08
• Study Start: 2023-10-01
• Primary Completion: 2028-05
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conduction System Pacing	conduction system pacing	Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.
Standard Pacing Method	right ventricular or biventricular pacing	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.

Primary Outcome Measures

Name	Time	Method
Heart Failure Hospitalization	12 months	Hospitalization due to heart failure as a main reason
All-cause death	12 months	Death from any cause

Secondary Outcome Measures

Name	Time	Method
Pacing-Induced Cardiomyopathy (PICM)	24 months	Pacing-related CHF meeting the echocardiographic criteria of PICM defined as a decrease in LVEF by \>=10% to the absolute value of \<50%
Change in global longitudinal strain (GLS)	24 months	An increase in GLS value of 20 absolute percentage points from baseline or an increase above -16%.
Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP)	24 months	pl/mL
Change in Quality of Life	24 months	Assessed with Short Form Health Survey (SF-36): 0 to 100; low QoL to high QoL - better outcome.
Change in exercise capacity	24 months	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
Atrial Fibrillation (AF) episodes	24 months	Occurrence of the first episode of AF in a patient with no previous history of atrial fibrillation (AF).
Response to Cardiac Resynchronization Therapy (CRT)	24 months	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
Atrial High Rate Episodes (AHRE) in pacemaker recordings	24 months	Occurrence or change of the burden of AHRE events in the records from the CIED.

Trial Locations

Locations (1)

Medical University of Silesia in Katowice; 🇵🇱 Katowice, Poland