A New Theory of Electrophysiological Mechanism of Atrial Fibrillation

NCT05845034 | Active Not Recruiting DMC

• 1 other identifier: CASE2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The electrophysiological mechanisms of atrial fibrillation remain disagreements. The goal of this clinical trail is to propose a new electrophysiological mechanism hypothesis of atrial fibrillation（AF）,meanwhile, the investigators sought to test the hypothesis that the superposition electrograms (SPEs) recorded during atrial fibrillation could be used as target sites for catheter ablation of atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from AF during follow-up

  At the one-year follow-up，AF occurring in the first 3 months after the ablation (blanking period) were censored.Beyond this, any AF episode that lasted for more than 30 seconds was categorized as a recurrence.

  one year

Secondary Outcomes (3)

• Acute success rate of AF termination during ablation procedure

  one year

• Complications

  one year

• freedom from documented AF/AT episode

  one year

Study Arms (2)

With additional SPEs ablation

EXPERIMENTAL

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

Procedure: PVI + SPEs ablation

Control Group

ACTIVE COMPARATOR

Patients who undergo PVI alone using ThermoCool SmartTouch catheter.

Procedure: PVI ablation

Interventions

PVI + SPEs ablation PROCEDURE

electrophysiology substrate mapping is the critical difference between both groups.

With additional SPEs ablation

PVI ablation PROCEDURE

electrophysiology substrate mapping is the critical difference between both groups.

Control Group

Eligibility Criteria

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

You may qualify if:

• Patients undergoing a first-time ablation procedure for AF
• Paroxysmal AF will be defined as a sustained episode lasting \> 7 days; Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 1 years; Long-lasting persistent AF will be more than 1 year and less than 5 years.
• Patients must be willing and able to comply with all peri-ablation and follow-up requirements.
• Patients with atrial fibrillation will to accept the procedure of ablation.
• Patients signed the written informed consent for the study.
• Patients can endure the required follow up.

You may not qualify if:

• Patients with contraindications to systemic anticoagulation with heparin or a direct thrombin inhibitor.
• Patients with thromboembolus in left atrial appendage.
• Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view).
• Patients allergic for contrast or iodine.
• Patients with the serum creatinine（SCr） \>3.5mg/dl
• Patients with life expectancy \< 12 months
• Patients who are in the period of pregnant

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 (3)

• Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.

  PMID: 9725923 RESULT

• Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.

  PMID: 15172410 RESULT

• Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.

  PMID: 22818076 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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: May 6, 2023
• Study Start: April 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: March 30, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)