Evaluating heart conduction issues after aortic valve replacement
InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study
NA · Institut d'Investigació Biomèdica de Bellvitge · NCT06481137
This study is testing how often new heart conduction problems happen after aortic valve replacement and whether they can be fixed, focusing on patients who develop specific issues after the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 209 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Bellvitge (other) |
| Locations | 1 site (L'Hospitalet de Llobregat, Barcelona) |
| Trial ID | NCT06481137 on ClinicalTrials.gov |
What this trial studies
This study investigates the occurrence of conduction disturbances in patients who develop new electrocardiographic conduction issues following transcatheter aortic valve implantation (TAVI). It focuses on patients with de novo left bundle branch block and assesses the need for cardiac pacing and clinical outcomes through electrophysiological studies conducted 3-7 days post-TAVI. The study employs a multicenter, longitudinal, and prospective approach, including continuous monitoring with an extended Holter device. The goal is to understand the reversibility of these conduction disturbances and improve patient management.
Who should consider this trial
Good fit: Ideal candidates include patients who have undergone TAVI and exhibit new-onset electrocardiographic conduction disturbances requiring electrophysiological evaluation.
Not a fit: Patients with prior pacemakers, complete right bundle branch block, or those needing cardiac resynchronization therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for patients experiencing conduction disturbances after TAVI, potentially reducing the need for permanent pacemakers.
How similar studies have performed: While there is ongoing research in this area, the specific approach of evaluating reversibility of conduction disturbances post-TAVI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
L'Hospitalet de Llobregat, Barcelona
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (RECRUITING)
Study contacts
- Study coordinator: Guillem Muntané Carol, MD, PhD
- Email: gmuntanec@bellvitgehospital.cat
- Phone: +342607500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Stenosis, Transcatheter Aortic Valve Implantation, Conduction Disturbances, Aortic stenosis