InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 209
- Locations
- 2
- Primary Endpoint
- Incidence of retrogradation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with indication for electrophysiological (EP) study after TAVI implantation according to European Guidelines. Patients must have persistent electrocardiographic conduction disturbances (ECG-CDs) that are present from day 2 after TAVI implantation (≥ 48h post-procedure):
- •De novo LBBB with QRS complex >150ms and/or PR interval ≥240ms.
- •QRS widening or post-procedural PR lengthening > 20ms in patients with baseline ECG-CDs.
Exclusion Criteria
- •Patients with previous pacemaker or implantable defibrillator.
- •Patients with baseline complete right bundle branch block.
- •Patients in need of cardiac resynchronization or physiological stimulation following TAVI.
- •Valve-in-valve procedures.
- •TAVI procedures in patients with severe aortic insufficiency.
- •Inability to sign the informed consent form.
Outcomes
Primary Outcomes
Incidence of retrogradation
Time Frame: 30 days
1\. Patients with positive EP: Evaluate the incidence of retrogradation of infra-Hisian conduction disturbance at 30-45 days following TAVI.
Need for cardiac pacing (incidence of advanced atrioventricular block)
Time Frame: 30 days
2\. Patients with negative EP: Evaluate the rate of patients in need for cardiac pacing (incidence of clinical events related to advanced atrioventricular block).
Secondary Outcomes
No secondary outcomes reported
Investigators
Guillem Muntané Carol
Principal Investigator
Institut d'Investigació Biomèdica de Bellvitge