Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI (COME-TAVI)

University of Montreal

Status: Enrolling

Conditions: Aortic Valve Stenosis; Left Bundle-Branch Block

Treatments: Device: Pacemaker implant; Device: Transcutaneous cardiac monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03303612

ICM#2015-1949

Details and patient eligibility

About

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).

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

EP-based approach/pacemaker implant

Other group

Description:

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.

Treatment:

Device: Pacemaker implant

Compared transcutaneous cardiac monitor

Other group

Description:

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.

Treatment:

Device: Transcutaneous cardiac monitor