Evaluating heart conduction issues after aortic valve replacement
Official title: InvesTigAtion of the reVersIbility of caRdiac Conduction disturbancEs Following Percutaneous Aortic ValvE Implantation in Patients With Severe aoRtic StEnosis: The TAVI-REVERSE Study
Run by Institut d'Investigació Biomèdica de Bellvitge · NCT06481137 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 209 (estimated) |
| Sponsor | Institut d'Investigació Biomèdica de Bellvitge Academic / other |
| Locations | 1 site (L'Hospitalet de Llobregat, Barcelona) |
| Status | Recruiting |
| Started | June 17, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | July 1, 2024 |
| Trial ID | NCT06481137 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients who have undergone TAVI and exhibit new-onset electrocardiographic conduction disturbances requiring electrophysiological evaluation.
✕Probably not a fit
Patients with prior pacemakers, complete right bundle branch block, or those needing cardiac resynchronization therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there is ongoing research in this area, the specific approach of evaluating reversibility of conduction disturbances post-TAVI is relatively novel.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
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Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
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Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
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Echo-AVCS: Drawing AI-powered clues from heart scans to confirm severe aortic stenosis
This study tests an AI-based echocardiography score to help confirm severe aortic stenosis in adults who are also getting CT calcium scoring.
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TAVI without on-site heart surgery: can selected centers do it safely?
This trial tests whether transcatheter aortic valve implantation can be done safely in certain hospitals that don’t have on-site cardiac surgery, for patients with severe aortic stenosis who are appropriately selected.
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Willem AI for early detection of aortic stenosis from a 12‑lead ECG
This project will test whether the Willem AI can detect aortic stenosis from routine 12‑lead ECGs in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.