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Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI

ConditionsLeft Bundle-Branch BlockAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontreal Heart Institute

About this trial

The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Informed consent to participate

Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)

Disqualifiers

Prior pacemaker or implantable cardioverter-defibrillator

Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI)

Class I or IIA indication for PPM implantation according to management guidelines

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pacemaker implant

    Device

    Patient will be in the electrophysiology laboratory. The doctor will freeze the groin area and a medication may be given to help the patient relax. A catheter will be inserted into the groin up to the heart and the heart's electrical system will be recorded.

  • Transcutaneous cardiac monitor

    Device

    Transcutaneous cardiac patches will allow continuous electrocardiographic monitoring for a 30-day period. For the first randomized patients at the Montreal Heart Institute, Icentia was used and then was changed to a m-Health® device which allows continuous cardiac monitoring. The PocketECG from m-Health® is attached to 3 electrodes on the chest and contains a SIM card that transmits to a server located in Burlington, Ontario .The COME-TAVI coordinating center and the associated site will be informed rapidly of any events that occur . These events include: Ventricular fibrillation; Sustained ventricular tachycardia Any RR interval \>5 sec; Third-degree AV block or Mobitz 2 AV block;

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: EP-based approach/pacemaker implantOther 1 intervention
Group B: Compared transcutaneous cardiac monitorOther 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.

This is the number of participants who experienced cardiovascular hospitalizations, and/or syncope, and/or death after TAVI.

Time frame
12 months

Secondary outcomes

1

Number of participants with cardiovascular hospitalizations.

This is the number of participants who were hospitalized for cardiovascular reasons within one-year post-TAVI.

Time frame
12 months
2

Number of participants with hospitalisations (Total)

This is the number of participants who were hospitalized one-year post-TAVI.

Time frame
12 months
3

Number of participants with emergency visits.

This is the number of participants who had emergency visits after TAVI.

Time frame
12 months
4

Number of participants experiencing syncope

This is the number of participants who experienced syncope after TAVI.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montreal Heart Institute

Lead sponsor

Source ClinicalTrials.gov
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