Actively Recruiting
Reversibility of Cardiac Conduction Disturbances Following TAVI
Led by Institut d'Investigació Biomèdica de Bellvitge · Updated on 2024-07-01
209
Participants Needed
1
Research Sites
132 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
The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block. In this study, the investigators will evaluate the incidence of retrogradation of infra-Hisian CDs in patients with de novo ECG-CDs and positive electrophysiological study (EPS) 3-7 days following TAVI. In addition, the investigators will evaluate the need for cardiac pacing and the incidence of clinical events in patients with negative EPS performed 3-7 days following TAVI. In this multicenter, longitudinal, prospective study, patients with clinical indication of EP study due to new-onset ECG-CDs after TAVI will be included. A permanent pacemaker will be implanted in patients with positive EPS and a second EPS will be performed in 30-45 days. Additionally, these patients will undergo 4-week continuous monitoring using the ePatch (Philips) long-term Holter recorder, to identify episodes of paroxysmal complete atrioventricular block. Patients with negative EP study will undergo clinical follow-up and continuous monitoring for 4 weeks.
CONDITIONS
Official Title
Reversibility of Cardiac Conduction Disturbances Following TAVI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients indicated for electrophysiological study after TAVI with persistent ECG conduction disturbances from day 2 post-procedure
- De novo left bundle branch block with QRS complex >150ms and/or PR interval 64240ms
- QRS widening or post-procedural PR lengthening >20ms in patients with baseline ECG conduction disturbances
You will not qualify if you...
- Previous pacemaker or implantable defibrillator
- Baseline complete right bundle branch block
- Need for cardiac resynchronization or physiological stimulation after TAVI
- Valve-in-valve procedures
- TAVI in patients with severe aortic insufficiency
- Inability to sign informed consent form
AI-Screening
AI-Powered Screening
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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
CONTACT
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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