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TAVR pacemaker study withdrawn before enrolling any patients

NCT ID NCT06857201

Knowledge-focused Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to compare a newer pacing method (left bundle branch area pacing) with the standard method (right ventricular pacing) in patients who developed heart block after TAVR valve replacement. The goal was to see which method better preserves heart function and reduces complications. However, the study was withdrawn before any participants were enrolled, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Successful insertion of TAVR for aortic stenosis 2. Persistent HDAVB or CHB identified within 30 days of TAVR ● HDAVB is defined as any of the following(9): Second-degree AV block type 2 (Mobitz II) in the presence of a QRS ≥120 msec, or 2:1 AV block in the presence of a QRS ≥120 msec, or ≥2 consecutive P waves at a constant physiologic rate that do not conduct to the ventricles, or transient third-degree AV block, or in the setting of AF a prolonged pause (\>3 s) or a fixed slow (\<50 beats/min) ventricular response rate. 3. Age ≥ 18 years Exclusion Criteria: 1. Patients with a pacemaker/ICD/CRT prior to TAVR 2. More than mild para-valvular regurgitation following TAVR 3. Patients with clinical indication for CRT-D or CRT-P 4. Patients with mechanical tricuspid valve 5. Renal failure - eGFR\<15 or on dialysis 6. Un-revascularized coronary artery disease with proximal multi-vascular coronary disease 7. Acute coronary syndrome with 3 months 8. Cardiogenic shock requiring inotropic therapy within 1 week 9. Life-expectancy \< 2 years 10. Anticipating heart transplant within 1 year 11. Pregnant or intending to become pregnant within the study period 12. Participating in another randomized controlled trial 13. Unable or unwilling to provide consent

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Arrhythmias, Cardiac atrioventricular block cardiac conduction defect heart failure second-degree atrioventricular block third-degree atrioventricular block

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complete heart block Conduction disorder Heart failure High degree second degree atrioventricular block Transcatheter aortic valve replacement (TAVR)

More trials for these conditions

Other studies related to the condition(s) this trial covers.