Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach in Patients With a New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (TAVI) a Bayesian Randomized Trial (COME-TAVI)
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years
• Informed consent to participate
• Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)
Locations
Other Locations
Canada
Mazankowski Alberta Heart Institute
RECRUITING
Edmonton
QEII Health Sciences Center
RECRUITING
Halifax
Hamilton Health Sciences Corporation
RECRUITING
Hamilton
London Health Sciences Center (LHSC)
RECRUITING
London
CIUSSS du Nord de l'Île de Mtl
RECRUITING
Montreal
Montreal Heart Institute
RECRUITING
Montreal
University of Ottawa Heart Institute (UOHI)
RECRUITING
Ottawa
New Brunswick Heart Center
NOT_YET_RECRUITING
Saint John
Centre hospitalier universitaire de Sherbrooke
RECRUITING
Sherbrooke
France
Centre Hospitalier Universitaire de Nantes
NOT_YET_RECRUITING
Nantes
Contact Information
Primary
Léna Rivard, MD, MSc
lena.rivard@umontreal.ca
514-376-3330
Backup
Caroline Girard, EP Prof.
caroline.girard@icm-mhi.org
514-376-3330
Time Frame
Start Date: 2017-10-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 250
Treatments
Other: EP-based approach/pacemaker implant
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.
Other: Compared transcutaneous cardiac monitor
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.
Related Therapeutic Areas
Sponsors
Leads: Montreal Heart Institute