An interventional study of Pacemaker implant and Transcutaneous cardiac monitor in Left Bundle-Branch Block and Aortic Valve Stenosis, sponsored by Montreal Heart Institute. Recruiting at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Montreal Heart Institute · Not applicable, Interventional, and Treatment
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).
The study population consists of pacemaker-free patients that are 18 years or older undergoing a TAVI with new onset left bundle branch block. Patient consent is required.
Patients meeting the inclusion criteria will be randomized in a 1:1 ratio to one of the following two groups:
Group 1: electrophysiology-based algorithmic approach
Group 2: standard clinical follow-up with transcutaneous cardiac monitoring.
Exclusion Criteria:
Subjects will undergo an EP study prior to hospital discharge and will receive a pacemaker implantation if the HV interval is ≥65 msec. In the case where the electrical slowdown is not confirmed by the electrophysiological study, the participant will not have a pacemaker implantation.
Device: Pacemaker implant
Subjects will undergo a minimum of 72 hour ECG monitoring in hospital and receive transcutaneous monitoring prior to hospital discharge for a duration of 30 days.
Device: Transcutaneous cardiac monitor
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 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;
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
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
Number of participants with hospitalisations (Total)
This is the number of participants who were hospitalized one-year post-TAVI.
Time frame: 12 months
Number of participants with emergency visits.
This is the number of participants who had emergency visits after TAVI.
Time frame: 12 months
Number of participants experiencing syncope
This is the number of participants who experienced syncope after TAVI.
Time frame: 12 months
Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)].
This is the incremental cost effectiveness ratio (ICER) for one strategy compared to the other.
Time frame: 12 months
Number of procedural complications in the group of EP-guided procedure compared to the group of cardiac monitoring.
This is the number of procedural complications in the group of EP-guided approach compared to cardiac monitoring within 30 days.
Time frame: 30 days
Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring.
This is the number of atrio-ventricular blocks in the EP-guided procedure group compared to the transcutaneous cardiac monitoring group within 12 months of TAVI
Time frame: 12 months
Plan to share: No
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Montreal Heart Institute