Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
NCT ID: NCT03303612
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2017-10-15
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Pacemaker 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.
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.
Transcutaneous 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;
Interventions
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Pacemaker 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.
Transcutaneous 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;
Eligibility Criteria
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Inclusion Criteria
* Informed consent to participate
* Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Montreal Heart Institute
OTHER
Responsible Party
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Principal Investigators
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Léna Rivard, MD, MSC
Role: PRINCIPAL_INVESTIGATOR
Montreal Heart Institute
Locations
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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
Montreal Heart Institute
Montreal, Quebec, Canada
CIUSSS du Nord de l'Île de Mtl
Montreal, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, Canada
Centre Hospitalier Universitaire de Nantes
Nantes, Cedex 01, France
Countries
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Central Contacts
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Facility Contacts
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References
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Rivard L, Nault I, Krahn AD, Daneault B, Roux JF, Natarajan M, Healey JS, Quadros K, Sandhu RK, Kouz R, Greiss I, Leong-Sit P, Gourraud JB, Ben Ali W, Asgar A, Aguilar M, Bonan R, Cadrin-Tourigny J, Cartier R, Dorval JF, Dubuc M, Durrleman N, Dyrda K, Guerra P, Ibrahim M, Ibrahim R, Macle L, Mondesert B, Moss E, Raymond-Paquin A, Roy D, Tadros R, Thibault B, Talajic M, Nozza A, Guertin MC, Khairy P. Rationale and Design of the Randomized Bayesian Multicenter COME-TAVI Trial in Patients With a New Onset Left Bundle Branch Block. CJC Open. 2023 Jul 13;5(8):611-618. doi: 10.1016/j.cjco.2023.05.009. eCollection 2023 Aug.
Other Identifiers
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ICM#2015-1949
Identifier Type: -
Identifier Source: org_study_id
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