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

June 4, 2025 updated by: Medical University of Silesia

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Katowice, Poland
        • Recruiting
        • Medical University of Silesia in Katowice
        • Contact:
        • Sub-Investigator:
          • Danuta Łoboda, MD, PhD
        • Sub-Investigator:
          • Rafał Gardas, MD, PhD
        • Sub-Investigator:
          • Jolanta Biernat, MD, PhD
        • Sub-Investigator:
          • Grzegorz Jarosiński, MD, PhD
        • Sub-Investigator:
          • Tomasz Soral, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in exercise capacity
Time Frame: 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
24 months
Response to Cardiac Resynchronization Therapy (CRT)
Time Frame: 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
24 months
Pacing-Induced Cardiomyopathy (PICM)
Time Frame: 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%
24 months
Change in global longitudinal strain (GLS)
Time Frame: 24 months
An increase in GLS value of 20 absolute percentage points from baseline or an increase above -16%.
24 months
Atrial Fibrillation (AF) episodes
Time Frame: 24 months
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
Time Frame: 24 months
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)
Time Frame: 24 months
pl/mL
24 months
Change in Quality of Life
Time Frame: 24 months
Assessed with Short Form Health Survey (SF-36): 0 to 100; low QoL to high QoL - better outcome.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Collaborators

Medical Research Agency, Poland

Investigators

  • Study Chair: Krzysztof S. Gołba, MD PhD, Silesian Medical University in Katowice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/ABM/03/00049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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