RecruitingNot ApplicableNCT03303612

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

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)

Sponsor

Montreal Heart Institute

Enrollment

250 participants

Start Date

Oct 15, 2017

Study Type

INTERVENTIONAL

Conditions

Left Bundle-Branch Block Aortic Valve Stenosis

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

Min Age: 18 Years

Inclusion Criteria3

Age ≥18 years
Informed consent to participate
Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)

Exclusion Criteria3

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

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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;