Driver-guided Ablation of Persistent Atrial Fibrillatiom

NCT ID: NCT04085731

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 181 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-21
• Study Completion Date: 2023-12-30

Brief Summary

This is a prospective, single-center, study. A targeted number of 181patients with persistent AF will be included according to pre-defined criteria. The ablation procedure consists on the identification of the arrhythmic substrate using a novel integrated mapping technique. We hypothesize that such approach may potentially lead to a mechanisms-targeted ablation strategy of persistent AF.

Detailed Description

This is a prospective, single-center, study enrolling a total of 181patients with persistent AF according to well defined inclusion and exclusion criteria. The ablation procedure consists on the identification of the arrhythmic substrate using a novel integrated 3D mapping technique followed by standard CPVA at the end of the procedure. We will ablate substrates showing fast and regular electrical activities, starting from areas with the fastest mean cycle length and/or areas that have consistent rotational or focal propagation pattern and/or areas that comprise the slow conduction zone of possible arrhythmia circuits. After substrate ablation and AF termination, arrhythmia inducibility will be assessed and, if not inducible, the procedure will be completed by standard CPVA. If AF is still inducible, a new 3D map will be performed to identify further targets to be eliminated. Electrical cardioversion may be done at the end of the procedure. We hypothesized that such approach may potentially lead to a mechanisms-targeted ablation strategy leading to elimination of arrhythmic sources in individual patients, thus improving their clinical outcome. We will also characterize, identify and target the real pathophysiological substrates. After ablation, AF recurrence will be assessed by implantable loop recorder or thans-telephonic ECG recording from the end of the 3 months blanking period to 12 months following the procedure.The duration of this study is expected to be 24 months, from the first patient enrollment to the last patient follow-up.

Conditions

Persistent Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Catheter ablation

Driver-guided catheter ablation of persistent atrial fibrillation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: lead

Responsible Party

Carlo Pappone

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Pappone, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy

Locations

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Carlo Pappone, MD

Role: CONTACT

carlo.pappone@af-ablation.org

+39 02 52774260

Carlo Pappone, MD

Role: CONTACT

carlo.pappone@af-ablation.org

+39 02 527742282

Facility Contacts

Carlo Pappone, MD, PhD

Role: primary

carlo.pappone@af-ablation.org

00390252774260

Carlo Pappone, MD

Role: backup

carlo.pappone@af-ablation.org

00390252774260

Other Identifiers

Persistent AF Ablation

Identifier Type: -

Identifier Source: org_study_id