Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
- Conditions
- Aortic Valve StenosisLeft Bundle-Branch Block
- Interventions
- Device: Transcutaneous cardiac monitorDevice: Pacemaker implant
- Registration Number
- NCT03303612
- Lead Sponsor
- Montreal Heart Institute
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Age ≥18 years
- Informed consent to participate
- Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Compared transcutaneous cardiac monitor 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. EP-based approach/pacemaker implant 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 with cardiovascular hospitalizations. 12 months This is the number of participants who were hospitalized for cardiovascular reasons within one-year post-TAVI.
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
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 participants experiencing syncope 12 months This is the number of participants who experienced syncope after TAVI.
Trial Locations
- Locations (10)
Mazankowski Alberta Heart Institute
🇨🇦Edmonton, Alberta, Canada
New Brunswick Heart Center
🇨🇦Saint-John, New Brunswick, Canada
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Hamilton Health Sciences Corporation
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Center (LHSC)
🇨🇦London, Ontario, Canada
University of Ottawa Heart Institute (UOHI)
🇨🇦Ottawa, Ontario, Canada
Centre hospitalier universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
CIUSSS du Nord de l'Île de Mtl
🇨🇦Montréal, Quebec, Canada
Centre Hospitalier Universitaire de Nantes
🇫🇷Nantes, Cedex 01, France