Aortic Valve Stenosis, Left Bundle-Branch Block
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICEPacemaker implant
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.
DEVICETranscutaneous cardiac monitor
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;
Sponsors
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Informed consent to participate * Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI. | 12 months | This is the number of participants who experienced cardiovascular hospitalizations, and/or syncope, and/or death after TAVI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with hospitalisations (Total) | 12 months | This is the number of participants who were hospitalized one-year post-TAVI. |
| Number of participants with emergency visits. | 12 months | This is the number of participants who had emergency visits after TAVI. |
| Number of participants experiencing syncope | 12 months | This is the number of participants who experienced syncope after TAVI. |
| Number of participants with cardiovascular hospitalizations. | 12 months | This is the number of participants who were hospitalized for cardiovascular reasons within one-year post-TAVI. |
| Number of procedural complications in the group of EP-guided procedure compared to the group of cardiac monitoring. | 30 days | This is the number of procedural complications in the group of EP-guided approach compared to cardiac monitoring within 30 days. |
| Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring. | 12 months | 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 |
| Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)]. | 12 months | This is the incremental cost effectiveness ratio (ICER) for one strategy compared to the other. |
Countries
Canada, France
Contacts
Primary ContactLéna Rivard, MD, MSc
Backup ContactCaroline Girard, EP Prof.
Outcome results
None listed