A Study on the Relationship Between Individualized Low Voltage Regions in Left Atrium and the Mechanism of Atrial Fibrillation in Persistent Atrial Fibrillation Under Ultra-High-Resolution Mapping

NCT06694610 | Not Yet Recruiting FDA Device

• 1 other identifier: CDSY-ILVRA-PAFM-UAH
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were significantly improved. According to the mapping results, the numerical calculation of the personalized low voltage region was carried out, and the personalized ablation route was designed according to the low voltage region.

Conditions

Atrial Fibrillation Recurrent

Keywords

心房颤动（Atrial Fibrillation）

Outcome Measures

Primary Outcomes (1)

• Immediate Atrial Fibrillation Termination Rate

  The number of atrial fibrillation rhythms ablated to sinus rhythm or flutter/atrial tachycardia during the procedure.

  Intraoperative Immediate

Secondary Outcomes (1)

• Ablation Success Rate at 12 Months Post-Operation.

  12 Months Post-Operation.

Other Outcomes (3)

• The number and location of re-entrant circuits mapped during surgery

  Intraoperative Immediate

• the location of ablation to sinus rhythm or flutter

  Intraoperative Immediate

• the number of three-dimensional mapping points

  Intraoperative Immediate

Study Arms (2)

non-pulmonary vein ablation group

EXPERIMENTAL

In the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated.

Procedure: non-pulmonary vein ablation group

only pulmonary vein ablation group

ACTIVE COMPARATOR

In the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point.

Procedure: only pulmonary vein ablation group

Interventions

non-pulmonary vein ablation group PROCEDURE

In the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated.

non-pulmonary vein ablation group

only pulmonary vein ablation group PROCEDURE

In the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point.

only pulmonary vein ablation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 85 years;
• Diagnosed with drug-refractory, symptomatic, persistent atrial fibrillation; Definition: At least one electrocardiogram (ECG) record of an atrial fibrillation episode within 12 months prior to enrollment.
• Non-valvular atrial fibrillation;
• Able to understand the purpose of the study, voluntarily participate in the study, the patient or their legal representative signs the informed consent form, and willing to complete follow-ups as required by the study protocol.-

You may not qualify if:

• Atrial fibrillation secondary to thyroid disease or other reversible factors;
• Imaging studies indicating intracardiac thrombus;
• Moderate to severe mitral stenosis or regurgitation;
• Left ventricular ejection fraction \<40%, or New York Heart Association (NYHA) functional class III or IV;
• Unstable angina;
• Myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment;
• Presence of mural thrombus, space-occupying disease, or other abnormalities that hinder vascular puncture or catheter manipulation;
• Contraindications to anticoagulation and a history of blood coagulation or bleeding abnormalities;
• Patients with active systemic infections; Patients who have had an atrial septal closure device implanted within the last 6 weeks;
• Female patients who are pregnant, breastfeeding, or unable to use contraception during the study period;
• Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumors); patients who have had an atrial septal closure device implanted within the last 6 weeks;
• Conditions affecting vascular access;
• Patients who are concurrently participating in other drug or device clinical trials;
• Any other abnormalities or diseases that the investigator deems should exclude the patient from the study enrollment.

Sponsors & Collaborators

• The Third People's Hospital of Chengdu: lead

Central Study Contacts

Prof.Liu

CONTACT

8613551044286; lhanx@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• 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: November 12, 2024
• First Posted: November 19, 2024
• Study Start: November 15, 2024
• Primary Completion: April 5, 2025
• Study Completion: April 5, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11