Phase-Aligned Atrial Fibrillation Mapping

NCT06892561 | Active Not Recruiting

• 1 other identifier: 23IPA1054947
• Study Type: observational
• Target: 336
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac arrhythmia in the upper chamber of the heart (atrial fibrillation) can be cured by burning. Physicians burn very small pieces of abnormal tissue. It is important to know where to burn. The investigators propose a new way to find out where to burn. The investigators will use a new way to analyze electrical signals inside the heart and build a new electric map. The study may lead to the development of new technology. In the future, novel technology may increase the success rate and the number of cured atrial fibrillation patients. This study is a retrospective study of data collected during routine clinical care: atrial fibrillation ablations. The investigators will compare intracardiac electrograms and atrial activation maps in patients who had successful ablation outcomes (no recurrence within 1 year) and those who experienced a recurrence of arrhythmia within 1 year after the procedure.

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation; pulmonary vein isolation; case-control study

Outcome Measures

Primary Outcomes (1)

• Persistent AF ablation outcome

  Cases are defined as successful persistent AF ablation cases (documented freedom from AF during ≥1 year after ablation). Controls are defined as failed persistent AF ablation (recurrent, persistent AF in patients with documented well-isolated pulmonary veins).

  1 year after AF ablation procedure

Study Arms (2)

successful persistent AF ablation

Cases are defined as successful persistent AF ablation cases (documented freedom from AF during ≥1 year after ablation).

failed persistent AF ablation

Controls are defined as failed persistent AF ablation (recurrent, persistent AF in patients with documented well-isolated pulmonary veins).

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study design: a retrospective case-control study of patients who underwent persistent AF ablation at Cleveland Clinic. The goal of the case-control study is to identify differences in AF mapping (using the proposed novel analytical approach) and persistent AF ablation strategy between the successful and failed persistent AF ablation cases. The selection of cases and controls will pay special attention to well-documented and verified successful and complete pulmonary vein isolation, as failed PVI is a well-known cause of failed AF ablation procedures, but it is not the goal of this study.

You may qualify if:

• Records of patients with persistent AF who underwent pulmonary vein isolation (PVI) with any additional AF ablation strategy with available stored digital AF mapping data. Persistent AF is defined as AF lasting more than 7 days.
• One/First AF ablation procedure (no prior atrial ablation procedures)
• Documented complete pulmonary vein isolation at the end of the ablation
• Available uniform, high-quality (as described below) clinical data required to detect AF recurrence during ≥ 1 year after ablation, and/or ECG monitoring (implantable loop recording or repeated long-term ECG monitoring via ECG patch or similar)

You may not qualify if:

• Familial AF, AF as a syndrome in rare diseases (cardiomyopathies / WPW/ channelopathies).
• Missing data of exposure (AF ablation map), outcome (definition of cases and controls), or covariates

Sponsors & Collaborators

• American Heart Association: collaborator
• Larisa Tereshchenko, MD, PhD: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Links

• American Heart Association Award

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff, Associate Professor of Medicine

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: August 16, 2023
• Primary Completion (Estimated): August 16, 2026
• Study Completion (Estimated): August 16, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)