NCT06481137 Reversibility of Cardiac Conduction Disturbances Following TAVI
| NCT ID | NCT06481137 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut d'Investigació Biomèdica de Bellvitge |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 209 participants |
| Start Date | 2024-06-17 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 209 participants in total. It began in 2024-06-17 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06481137 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06481137 currently recruiting?
Yes, NCT06481137 is actively recruiting participants. Contact the research team at gmuntanec@bellvitgehospital.cat for enrollment information.
Where is the NCT06481137 trial being conducted?
This trial is being conducted at L'Hospitalet de Llobregat, Spain.
Who is sponsoring the NCT06481137 clinical trial?
NCT06481137 is sponsored by Institut d'Investigació Biomèdica de Bellvitge. The trial plans to enroll 209 participants.