AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.

Cardiovascular Diseases Clinical Trial

Official title:

A Post Market, Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using the Ablamap® Electrographic FLOW (EGF) Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05481359
• Other study ID #: CP-003
• Status: Active, not recruiting
• Start date: September 12, 2022
• Est. completion date: December 2023

Study information

• Verified date: November 2023
• Source: Ablacon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This post-market global registry will evaluate the ability of the Ablamap® Software to identify atrial fibrillation sources and guide ablation therapy in patients with atrial fibrillation.

Description:

The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of the Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of the Ablamap® Software to identify AF sources and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with atrial fibrillation and meet inclusion/exclusion criteria will be eligible for enrollment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Suitable candidate for intra-cardiac mapping and ablation of arrhythmias.

2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.

3. Subjects with a history of documented symptomatic atrial fibrillation.

Exclusion Criteria:

1. Subjects who are not candidates for cardiac ablation procedures.

2. Pregnant or nursing.

3. Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Cardiovascular Diseases
• Heart Diseases
• Pathologic Processes

Intervention

Device:
• Ablamap Software
Subjects will receive cardiac ablation guided by the Ablamap software. The software will identify atrial fibrillation sources to help guide ablation therapy in patients with persistent atrial fibrillation.

Locations

Country	Name	City	State
United States	Piedmont Healthcare	Athens	Georgia
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ablacon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute procedure success defined as the ability to successfully ablate AF sources identified by the Ablamap software	The ability to successfully ablate AF sources identified by the Electrographic FLOW maps of the atria pre and post ablation to determine if there is a diminished or absence of the source.	During the procedure
Secondary	Freedom from documented episodes of AF recurrence	Freedom from documented episodes of atrial fibrillation recurrence following the blanking period (90 days post procedure through 12 months).	3-12 months