Actively Recruiting
Investigation of the Reversibility of Cardiac Conduction Disturbances Following Percutaneous Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The TAVI-REVERSE Study
Led by Institut d'Investigació Biomèdica de Bellvitge · Updated on 2024-07-01
209
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Institut d'Investigació Biomèdica de Bellvitge
Lead Sponsor
H
Hospital Universitari de Bellvitge
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates the management of patients who develop conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI), focusing especially on those with new electrocardiographic conduction disturbances such as left bundle branch block. The study aims to evaluate how often infra-Hisian CDs improve (retrograde) in patients with positive electrophysiological study (EPS) results 3 to 7 days after TAVI. It also assesses the need for cardiac pacing and clinical events in patients with negative EPS at the same time point. Participants are divided into two groups based on their initial EPS results taken 3 to 7 days after TAVI. Patients with positive EPS receive a permanent pacemaker, continuous ECG monitoring with the ePatch device for 4 weeks, and a second EPS 30 to 45 days after TAVI. Those with negative EPS undergo continuous ECG monitoring for 4 weeks and clinical follow-up without pacemaker implantation. During the study, participants will have continuous heart rhythm monitoring using the ePatch device for one month post-TAVI. Patients with positive EPS will have a second EPS about one month later to check conduction status. The main outcomes measured include the incidence of retrogradation of conduction disturbances and the need for cardiac pacing within 30 days. Clinical events and heart rhythm data are closely monitored throughout the study period to understand the progression of conduction disturbances after TAVI.
CONDITIONS
Brief Title
Reversibility of Cardiac Conduction Disturbances Following TAVI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with indication for electrophysiological study after TAVI implantation according to European Guidelines
- Persistent electrocardiographic conduction disturbances present from day 2 after TAVI (≥48 hours post-procedure)
- De novo left bundle branch block with QRS complex >150ms and/or PR interval ≥240ms
- QRS widening or post-procedural PR lengthening >20ms in patients with baseline ECG conduction disturbances
You will not qualify if you...
- Patients with a previous pacemaker or implantable defibrillator
- Patients with baseline complete right bundle branch block
- Patients needing cardiac resynchronization or physiological stimulation after TAVI
- Valve-in-valve procedures
- TAVI procedures in patients with severe aortic insufficiency
- Inability to sign the informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - 5 days window post-TAVI
Participants undergo the initial electrophysiological study (EP study) 3 to 7 days after TAVI to assess cardiac conduction disturbances.
1 visit (in-person) for initial EP study
Duration - 4 weeks
Continuous cardiac rhythm monitoring is performed using the ePatch device for 4 weeks following TAVI.
Continuous monitoring with ePatch device
Duration - 15-day window between 30 and 45 days post-TAVI
For participants with a positive initial EP study, a second EP study is performed 30 to 45 days after TAVI to evaluate the reversibility of conduction disturbances.
1 visit (in-person) for follow-up EP study
Trial Site Locations
Total: 1 location
1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08097
Actively Recruiting
Research Team
G
Guillem Muntané Carol, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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