Clinical trial NCT03303612: Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Left Bundle-Branch Block
Aortic Valve Stenosis
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with cardiovascular hospitalizations.
timeFrame: 12 months
measure: Number of participants with hospitalisations (Total)
timeFrame: 12 months
measure: Number of participants with emergency visits.
timeFrame: 12 months
measure: Number of participants experiencing syncope
timeFrame: 12 months
measure: Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)].
timeFrame: 12 months
measure: Number of procedural complications in the group of EP-guided procedure compared to the group of cardiac monitoring.
timeFrame: 30 days
measure: Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring.
timeFrame: 12 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute
state: Alberta
city: Saint-John
country: Canada
facility: New Brunswick Heart Center
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center (LHSC)
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute (UOHI)
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec, Canada
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS du Nord de l'Île de Mtl
state: Quebec
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
state: Cedex 01
Study officials:
affiliation: Montreal Heart Institute
name: Léna Rivard, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References: