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Electrophysiology-Guided Care for Left Bundle Branch Block After TAVI (COME-TAVI Trial)
N/A
Recruiting
Led By Léna Rivard, MD, MSC
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Be older than 18 years old
Must not have
Class I or IIA indication for PPM implantation according to management guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare an electrophysiology-based algorithm to standard clinical follow-up in patients who have had TAVI and new left bundle branch block. The goal is to see if the electrophysiology-based algorithm can reduce syncope, hospitalization, and death.
Who is the study for?
This trial is for adults over 18 who've recently had a TAVI procedure and developed a new left bundle branch block (LBBB) by the second day after surgery. It's not open to those with prior pacemakers, defibrillators, or pre-existing LBBB/RBBB, nor those already meeting criteria for pacemaker implantation.
What is being tested?
The study aims to see if an electrophysiology-guided approach using algorithms can better prevent fainting spells, hospital visits, or death compared to standard clinical monitoring in patients with new LBBB post-TAVI. Participants will either receive regular follow-ups or be monitored with a transcutaneous cardiac device.
What are the potential side effects?
Potential side effects may include discomfort at the monitor site, skin irritation from the transcutaneous cardiac monitor adhesive, and risks associated with pacemaker implant such as infection or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am recommended to get a pacemaker based on guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients with cardiovascular hospitalization, and/or syncope, and/or death after TAVI.
Secondary study objectives
Cost-effectiveness of EP-guided procedure compared to cardiac monitoring [incremental cost effectiveness ratio (ICER)].
Number of atrio-ventricular blocks in the group of EP-guided procedure compared to the group of transcutaneous cardiac monitoring.
Number of participants experiencing syncope
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: EP-based approach/pacemaker implantExperimental Treatment1 Intervention
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.
Group II: Compared transcutaneous cardiac monitorExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Pacemaker implant
2019
N/A
~80
Find a Location
Who is running the clinical trial?
Montreal Heart InstituteLead Sponsor
123 Previous Clinical Trials
80,560 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
800 Patients Enrolled for Aortic Valve Stenosis
Léna Rivard, MD, MSCPrincipal InvestigatorMontreal Heart Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You have a specific type of heart block that developed after a heart valve procedure.I am recommended to get a pacemaker based on guidelines.You have a pre-existing condition called right bundle branch block or left bundle branch block.
Research Study Groups:
This trial has the following groups:- Group 1: EP-based approach/pacemaker implant
- Group 2: Compared transcutaneous cardiac monitor
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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