NCT Number: NCT03303612
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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;
Time frame: 12 months
This is the number of participants who experienced cardiovascular hospitalizations, and/or syncope, and/or death after TAVI.
Time frame: 12 months
This is the number of participants who were hospitalized for cardiovascular reasons within one-year post-TAVI.
Time frame: 12 months
This is the number of participants who were hospitalized one-year post-TAVI.
Time frame: 12 months
This is the number of participants who had emergency visits after TAVI.
Time frame: 12 months
This is the number of participants who experienced syncope after TAVI.
Time frame: 12 months
This is the incremental cost effectiveness ratio (ICER) for one strategy compared to the other.
Time frame: 30 days
This is the number of procedural complications in the group of EP-guided approach compared to cardiac monitoring within 30 days.
Time frame: 12 months
This is the number of atrio-ventricular blocks in the EP-guided procedure group compared to the transcutaneous cardiac monitoring group within 12 months of TAVI
Contact information is provided by the study sponsor or research team.
Caroline Girard, EP Prof.
CONTACT
514-376-3330 ext. 2905
Léna Rivard, MD, MSc
CONTACT
514-376-3330 ext. 2120
Montreal Heart Institute
Other
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)
Acronym: COME-TAVI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07065123
Aortic Stenosis, Aortic Valve Disease
View Trial DetailsNCT05884359
Arrhythmias, Cardiac, Bundle-Branch Block
Boston, Massachusetts, United States
View Trial DetailsNCT05769036
Arrhythmias, Cardiac, Bundle-Branch Block
Tomsk, Russia
View Trial DetailsNCT06148883
Arrhythmias, Cardiac, Bundle-Branch Block
Marseille, France
View Trial Details