A New Approach for Catheter Ablation of Atrial Fibrillation

NCT ID: NCT05989321

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-07-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PVI alone group

Patients who undergo PVI alone using ThermoCool SmartTouch catheter.

PVI alone

Intervention Type PROCEDURE

pulmonary vein isolation

PVI + SPs ablation group

Patients who undergo PVI + SPs ablation using ThermoCool SmartTouch catheter.

PVI + SPs ablation

Intervention Type PROCEDURE

pulmonary vein isolation + SPs ablation

Interventions

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PVI alone

pulmonary vein isolation

Intervention Type PROCEDURE

PVI + SPs ablation

pulmonary vein isolation + SPs ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role lead

Responsible Party

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mingli Zhou

associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mingli Zhou, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Kunming Medical University

Locations

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The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status

Countries

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China

References

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Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

Reference Type RESULT
PMID: 32860505 (View on PubMed)

Other Identifiers

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IIT-2023-0052-XXG-004

Identifier Type: -

Identifier Source: org_study_id

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