Driver-guided Ablation of Persistent Atrial Fibrillatiom

NCT04085731 | Unknown DMC

• 1 other identifier: Persistent AF Ablation
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from any AF or atrial tachycardia assessed from the end of the months blanking period to 12 months after ablation.

  AF recurrences will be documented by implantable loop recorder or trns-telephonic ECG recording

  12 months after ablation

Secondary Outcomes (3)

• Identification of electrophysiological substrate

  during the procedure

• inducibility of AF after the procedure

  during the procedure

• AF burden

  12 months after ablation

Interventions

Catheter ablation PROCEDURE

Driver-guided catheter ablation of persistent atrial fibrillation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 181 subjects suffering from persistent Atrial Fibrillation will be enrolled. Subject screening and enrollment will be carried out for approximately 12 months. A subject, who mets all of the inclusion criteria, and none of the exclusion criteria, is eligible to participate in this study. All patients will be accounted for and documented, assigning an identification code linked to their names, alternative identification, or contact information.This log will be kept up to date throughout the clinical study by the principal investigator. To ensure subject privacy and confidentiality of data this log must be maintained throughout the clinical study at the clinical site.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Carlo Pappone, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Pappone, MD

CONTACT

+39 02 52774260; carlo.pappone@af-ablation.org

Carlo Pappone, MD

CONTACT

+39 02 527742282; carlo.pappone@af-ablation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 7, 2019
• First Posted: September 11, 2019
• Study Start: September 21, 2019
• Primary Completion: September 28, 2023
• Study Completion: December 30, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

IT (1)