Rotor Modulation Ablation for the Treatment of Persistent Atrial Fibrillation

NCT06539819 | Not Yet Recruiting

• 1 other identifier: 2024-KY-048
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

For Persistent atrial fibrillation (PeAF), the therapeutic effect of catheter ablation needs to be further improved. 3.Circumferential pulmonary vein isolation (CPVI) is the cornerstone of catheter ablation of AF, and additional ablation methods such as linear ablation or fragmentation potential ablation plus CPVI have been demonstrated to improve the treatment effect of PeAF, but there is still a large gap with the ideal ablation treatment effect.Recent studies have shown that the "rotor" is an important mechanism for the maintenance of PeAF, and related studies have shown that rotor modulation ablation may further improve the success rate of catheter ablation for PeAF. However, on the one hand, there is a lack of effective mapping catheter tool for rotor mapping, and on the other hand, the reproducibility of some related studies still needs to be further confirmed, and further clinical studies are needed to explore whether rotor modulation ablation can improve the success rate of catheter ablation for PeAF. The EnSite™ LiveView dynamic mapping system, combined with the HD Grid mapping catheter, provides a effective mapping tool for clinical surgeons. In the early clinical practice, we successfully completed the rotor mapping ablation using the mapping system, and there was no complication during the operation, which was safe and reliable, and achieved good intraoperative and postoperative results. We intend to conduct this clinical study to explore whether rotor ablation combined with BOX ablation can further improve the efficacy of PeAF compared with BOX ablation alone, and provide guidance for catheter ablation treatment of PeAF. This is a single-center, randomized, parallel-controlled, single-blind clinical trial, and we plan to enroll 360 subjects randomized into Electrical Posterior Box Isolation and Rotor Modulation Ablation group (R\&B group) and Electrical Posterior Box Isolation group (BO group), The corresponding surgery was performed according to the group, and the postoperative follow-up was 12 months, and the main observation endpoint was the remission rate of atrial fibrillation one year after surgery.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• The rate of freedom from AF within one year after surgery

  The rate of freedom from AF within one year after surgery

  1, 3, 6, 12 months after surgery

Secondary Outcomes (4)

• Incidence of other atrial arrhythmias within one year after surgery

  1, 3, 6, 12 months after surgery

• Cardiac function

  12 months after surgery

• Incidence of thrombosis-related events

  12 months after surgery

• Serious complications associated with ablation procedure

  12 months after surgery

Study Arms (2)

Electrical Posterior Box Isolation and Rotor Modulation Ablation group (R&B group)

EXPERIMENTAL

The subject's surgical procedure is electrical posterior box isolation plus rotor modulation ablation.

Procedure: Electrical Posterior Box Isolation and Rotor Modulation Ablation group (R&B group)

Electrical Posterior Box Isolation group (BO group)

ACTIVE COMPARATOR

The subject's surgical procedure is electrical posterior box isolation.

Procedure: Electrical Posterior Box Isolation group (BO group)

Interventions

Electrical Posterior Box Isolation and Rotor Modulation Ablation group (R&B group) PROCEDURE

the intervention is conducting electrical posterior box isolation plus rotor modulation ablation

Electrical Posterior Box Isolation and Rotor Modulation Ablation group (R&B group)

Electrical Posterior Box Isolation group (BO group) PROCEDURE

the intervention is conducting electrical posterior box isolation alone

Electrical Posterior Box Isolation group (BO group)

Eligibility Criteria

• Age: 21 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Clinical Diagnosed of persistent atrial fibrillation； 2. Has an indication for radiofrequency ablation surgery and no contraindications to radiofrequency ablation (according to Current knowledge and management of atrial fibrillation: consensus of Chinese experts 2021)；3. Patients between the ages of 20 and 80 years, male or female；4. Left atrial systolic anteroposterior diameter (LAs)\<55mm measured by thoracic ultrasound； 5. Patients who agree to undergo clinical trials and comply with the protocols, voluntarily sign the informed consent form.

You may not qualify if:

• \. History of previous radiofrequency ablation of atrial fibrillation; 2. Left ventricular ejection fraction (LVEF) \< 30% measured by thoracic ultrasound; 3. Cardiac surgery within the previous 180 days or expecting cardiac surgery within 180 days; 4. Coronary PTCA/stenting within the previous 90 days; 5. Patients with severe pulmonary, hepatic and renal insufficiency; 6. Diagnosed atrial myxoma; 7. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment; 8. Women who are pregnant or who plan to become pregnant during the study; 9. Acute illness or active infection at time of index procedure; 10. Acute coronary syndrome within the previous 60 days; 10. History of blood clotting or bleeding abnormalities; 12. Contraindication to anticoagulation; 13. Life expectancy less than 1 year; 14. Uncontrolled heart failure; 15. Presence of an intramural thrombus, tumor, or other abnormality that precludes catheter introduction or positioning; 16. Cannot be removed from antiarrhythmic drugs for reasons other than atrial fibrillation; 17. Unwilling or unable to provide informed consent; 18. Uncontrolled alcoholics; 19. Patients with hypertrophic cardiomyopathy; 20. Patients with poorly controlled hypertension (blood pressure \>140/90 mmHg despite antihypertensive therapy).

Sponsors & Collaborators

• Zhujiang Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

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: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-06