A New Approach for Catheter Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05989321
• Other study ID #: IIT-2023-0052-XXG-004
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: August 2023
• Source: The Second Affiliated Hospital of Kunming Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 15, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• PVI alone
pulmonary vein isolation
• PVI + SPs ablation
pulmonary vein isolation + SPs ablation

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Kunming Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	freedom from AF within 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	the acute termination of AF during the procedure	Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.	during the procedure