Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation (TAVI-PACE)

May 26, 2023 updated by: Ashkan Eftekhari, Aalborg University Hospital

The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients with severe aortic stenosis and left ventricular ejection fraction.Participants will be randomized to:

  • Prophylactic pacemaker implantation prior TAVI
  • Conservative strategy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND Transcatheter aortic valve implantation (TAVI) is standard of care treatment for patients with severe aortic stenosis ≥ 75 years and/or not eligible for surgical aortic valve replacement 1. There are two types of prosthetic valves: balloon expandable (BE) and self-expandable (SE) types with their distinct features 2. The TAVI-procedure and preexisting conditions in this population entails a risk of permanent pacemaker implantation following TAVI due to conduction disturbances related to the valve implantation and valve type (BE vs. SE). The rate of permanent pacemaker implantation after TAVI is between 2.3 - 36 % depending on valve type and pre-existing conditions3. Major risk factors are right bundle branch block (RBBB), left ventricular outflow track calcification, deeper valve implantation, and SE valves4. Pre-existing RBBB in patients undergoing TAVI occurs in 10% of the cases and it is associated with poor outcome5 in terms of higher pacemaker rate and mortality. Advanced conduction disturbances in patients with pre-existing RBBB occur within three days after the TAVI-procedure6. Hence, pre-existing RBBB is a major risk factor in the TAVI-population with higher mortality7 and needs special attention in peri-operative care. Current European Society Cardiology guidelines do not recommend prophylactic pacemaker implantation in patients without indication for permanent pacing8. However, cardiac pacing is associated with a risk of complications and development of heart failure9, and there is no randomized trial demonstrating a benefit of prophylactic pacemaker implantation in patients with pre-existing RBBB. Although previous observational data suggest prophylactic pacemaker implantation in patients with pre-existing RBBB shortens the TAVI procedure and prevents rehospitalization due to heart block10. Hence, there is a gap in knowledge regarding the outcome of prophylactic permanent pacemaker implantation in patients undergoing TAVI with pre-procedural RBBB and additional risk factors for need of post-procedural permanent pacing. This study aims to evaluate the clinical outcome and safety of prophylactic pacemaker implantation in this high-risk patient group versus a conservative strategy in a randomized clinical trial.

PURPOSE To evaluate safety and outcomes of prophylactic permanent pacemaker implantation in patients with RBBB undergoing TAVI.

HYPOTHESIS Prophylactic permanent pacemaker implantation reduces composite primary outcome in patients with RBBB undergoing TAVI.

Study Type

Interventional

Enrollment (Estimated)

320

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

  • Name: Ashkan Eftekhari, MD PhD
  • Phone Number: +4597664465
  • Email: asef@rn.dk

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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing TAVI indicated by severe valvular aortic stenosis
  • Written informed consent
  • Left ventricular ejection fraction ≥ 40 %
  • Persistent RBBB in 12-lead electrocardiogram (RSR' pattern in V1-3, QRS duration > 120 milliseconds, and wide S wave in leads I, aVL, V5-6)

Exclusion Criteria:

  • Other indications for pacemaker implantation or previously implanted pacemaker
  • Life expectancy < 1 year
  • No written informed consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prophylactic pacemaker implantation
Brady-pacemaker implantation prior the TAVI-procedure. Pacemaker modus is according to local conditions.
Device: Prophylactic pacemaker implantation
Pacemaker implantation prior the TAVI-procedure
No Intervention: Usual care
Pacemaker implantation after TAVI if atrioventricular block occurs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Events in the control arm
Time Frame: 12 months
Composite of all-cause mortality, unplanned pacemaker implantation and new onset of heart failure
12 months

Collaborators and Investigators

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

Sponsor

Aalborg University Hospital

Investigators

  • Principal Investigator: Ashkan Eftekhari, Aalborg University Hospital

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 (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAVI-PACE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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