Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pacemaker implant, Transcutaneous cardiac monitor.
- Who it may be relevant to
- Registry conditions: Left Bundle-Branch Block, Aortic Valve Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada, France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Device 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. - Device 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 info
Primary outcome measures
- Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI. [Time frame: 12 months]
Secondary outcome measures (7)
- Number of participants with cardiovascular hospitalizations. [Time frame: 12 months]
- Number of participants with hospitalisations (Total) [Time frame: 12 months]
- Number of participants with emergency visits. [Time frame: 12 months]
- Number of participants experiencing syncope [Time frame: 12 months]
- Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)]. [Time frame: 12 months]
- Number of procedural complications in the group of EP-guided procedure compared to the group of cardiac monitoring. [Time frame: 30 days]
- Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring. [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 9 centers
- Mazankowski Alberta Heart Institute — Edmonton
- New Brunswick Heart Center — Saint John
- QEII Health Sciences Center — Halifax
- Hamilton Health Sciences Corporation — Hamilton
- London Health Sciences Center (LHSC) — London
- University of Ottawa Heart Institute (UOHI) — Ottawa
- Montreal Heart Institute — Montreal
- CIUSSS du Nord de l'Île de Mtl — Montreal
- … and 1 more center
France · 1 center
- Centre Hospitalier Universitaire de Nantes — Nantes
Publications
- 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 PMID 37720184
Identifiers
NCT: NCT03303612 · ICM#2015-1949