Reversibility of Cardiac Conduction Disturbances Following TAVI

NCT06481137 | Recruiting

• 2 other identifiers: ICPS025/24PI23/00310
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcatheter Aortic Valve Implantation; Aortic Stenosis; Conduction Disturbances

Keywords

Aortic stenosis; Transcatheter Aortic Valve Implantation; Conduction Disturbances

Outcome Measures

Primary Outcomes (2)

• Incidence of retrogradation

  1\. Patients with positive EP: Evaluate the incidence of retrogradation of infra-Hisian conduction disturbance at 30-45 days following TAVI.

  30 days

• Need for cardiac pacing (incidence of advanced atrioventricular block)

  2\. Patients with negative EP: Evaluate the rate of patients in need for cardiac pacing (incidence of clinical events related to advanced atrioventricular block).

  30 days

Study Arms (2)

Positive initial (3-7 days following TAVI) electrophysiological study (EP+)

EXPERIMENTAL

Permanent pacemaker implantation. Continuous ECG monitoring during 4 weeks. Second EP study 30-45 days after TAVI.

Diagnostic Test: Electrophysiological study (EP study); Diagnostic Test: ePatch (extended Holter Monitoring)

Negative initial (3-7 days following TAVI) electrophysiological study (EP-)

OTHER

Continuous ECG monitoring during 4 weeks.

Diagnostic Test: ePatch (extended Holter Monitoring)

Interventions

Electrophysiological study (EP study) DIAGNOSTIC_TEST

Electrophysiological study: A second EP study 30-45 days after TAVI will be performed in the group of patients with positive EP study 3-7 days after TAVI.

Positive initial (3-7 days following TAVI) electrophysiological study (EP+)

ePatch (extended Holter Monitoring) DIAGNOSTIC_TEST

Continuous cardiac rhythm monitoring using the ePatch (Philips) will be performed during 4 weeks after TAVI

Negative initial (3-7 days following TAVI) electrophysiological study (EP-); Positive initial (3-7 days following TAVI) electrophysiological study (EP+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead
• Hospital Universitari de Bellvitge: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital Vall d'Hebron: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital Universitario A Coruna Spain: collaborator
• Hospital Clinico Universitario de Santiago: collaborator
• Hospital Universitario Central de Asturias: collaborator
• Hospital Universitario Marqués de Valdecilla: collaborator
• Hospital Clínico Universitario de Valladolid: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08097, Spain

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Guillem Muntané Carol, MD, PhD

CONTACT

+342607500; gmuntanec@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 1, 2024
• Study Start: June 17, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: During the duration of the study
• Access Criteria: Request to the PI

Locations

ES (1)