A New Approach for Catheter Ablation of Atrial Fibrillation

NCT05989321 | Completed DMC

• 1 other identifier: IIT-2023-0052-XXG-004
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the acute termination of AF during the procedure

  during the procedure

Study Arms (2)

PVI alone group

Patients who undergo PVI alone using ThermoCool SmartTouch catheter.

Procedure: PVI alone

PVI + SPs ablation group

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

Procedure: PVI + SPs ablation

Interventions

PVI alone PROCEDURE

pulmonary vein isolation

PVI alone group

PVI + SPs ablation PROCEDURE

pulmonary vein isolation + SPs ablation

PVI + SPs ablation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

These cases are from a university hospital

You may qualify if:

• patients with underwent the first catheter ablation for symptomatic AF

You may not qualify if:

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

Sponsors & Collaborators

• The Second Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

Related 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 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.

  PMID: 32860505 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Mingli Zhou, M.D.

  The Second Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 15, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)