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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Silesia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Research Agency, Poland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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