A New Approach for Catheter Ablation of Atrial Fibrillation

August 3, 2023 updated by: mingli Zhou, The Second Affiliated Hospital of Kunming Medical University

A New Approach for Catheter Ablation of Atrial Fibrillation: a Retrospective Cohort Study

This is a retrospective cohort study of radiofrequency ablation for the treatment atrial fibrillation(AF). Based on the electrophysiological phenomena found in these cases, the investigators propose a hypothesis regarding the underlying electrophysiological mechanism of AF, as well as a novel approach for catheter ablation of AF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators propose a new electrophysiological mechanism for AF: the superposition hypothesis. The investigators tested this hypothesis by conducting the retrospective cohort study to determine if superposition potentials (SP) can identify the critical regions where AF is sustained and if ablating SPs can improves the long-term efficacy.

The study consecutively collected patients with underwent the first catheter ablation for symptomatic AF in a university hospital from March 2021 to June 2022, including paroxysmal AF (lasting <7 days), persistent AF (lasting >7 days and <1 year without electrical cardioversion) and long-term persistent AF (lasting >1 year), aged between 18 and 80 years old. AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at each clinic visit. The eligible patients were divided into two groups: the pulmonary vein isolation(PVI) alone group (n=56) and the PVI + SPs ablation group(n=60).Comprehensive clinical history and procedural data of patients were collected from electronic medical records.

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • The Second Affiliated Hospital of Kunming Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

These cases are from a university hospital

Description

Inclusion Criteria:

  • patients with underwent the first catheter ablation for symptomatic AF

Exclusion Criteria:

  • patients with more than one missing follow-up would be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PVI alone group
Patients who undergo PVI alone using ThermoCool SmartTouch catheter.
Procedure: PVI alone
pulmonary vein isolation
PVI + SPs ablation group
Patients who undergo PVI + SPs ablation using ThermoCool SmartTouch catheter.
Procedure: PVI + SPs ablation
pulmonary vein isolation + SPs ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
freedom from AF within 12 months
Time Frame: 12 months
AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at each clinic visit. AF recurrence was defined as the occurrence of AF lasting at least 30 seconds after the 3-month blanking period.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the acute termination of AF during the procedure
Time Frame: during the procedure
Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.
during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Kunming Medical University

Investigators

  • Principal Investigator: Mingli Zhou, M.D., The Second Affiliated Hospital of Kunming Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2023-0052-XXG-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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