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NCT Number: NCT05989321

A New Approach for Catheter Ablation of Atrial Fibrillation

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVI alone

Procedure

pulmonary vein isolation

PVI + SPs ablation

Procedure

pulmonary vein isolation + SPs ablation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Kunming Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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