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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Awards & 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

0 / 2Eligibility criteria met