Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation (AF-PACC-CRYO)

The purpose of this study was to verify the safety and efficacy of routine and extended vestibular ablation in the treatment of paroxysmal/short-course persistent atrial fibrillation.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: cryoablation

Detailed Description

The purpose of this study was to verify the safety and efficacy of routine and extended vestibular ablation using the Medtronic Arctic Front AdvanceTM catheter in the treatment of paroxysmal/short-course persistent atrial fibrillation

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years old ≤ age ≤ 85 years old;
2. Patients with paroxysmal/short-term persistent atrial fibrillation;
3. Be able to understand the purpose of the research, voluntarily participate in the research and sign the informed consent.

Exclusion Criteria:

1. Echocardiography shows that the left atrium diameter is greater than or equal to 45mm;
2. Preoperative CT or esophageal echocardiography suggests that there is a thrombus in the left atrium/left atrial appendage;
3. Those who have undergone left atrial ablation or left atrial surgery;
4. Those who have received simple left atrial appendage occlusion;
5. New York heart function class (NYHA) class III or IV congestive heart failure or LVEF (%) less than 40%;
6. Those who have undergone valve repair;
7. Preoperative electrocardiogram or Holter confirmed the presence of typical atrial flutter or other supraventricular tachycardia (holding The duration is greater than 30 s);
8. Secondary atrial fibrillation, including uncontrolled hyperthyroidism, acute alcoholism, cardiac surgery postoperative atrial fibrillation, etc.;
9. History of acute coronary events or percutaneous coronary stent intervention within 6 months before enrollment;
10. Those with a history of cardioverter-defibrillator (ICD) implantation or a history of cardiac resynchronization therapy (CRT);
11. History of stroke or transient ischemic attack within 6 months before enrollment;
12. Those with obvious bleeding tendency who cannot receive postoperative systemic anticoagulation;
13. Severe structural heart disease, including moderate to severe mitral insufficiency or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.;
14. Combined with other serious diseases, the life expectancy is less than 12 months;
15. Women who are pregnant, breastfeeding and planning to become pregnant;
16. Have participated in or are participating in clinical investigators of other drugs or devices within 3 months before enrollment;
17. Other conditions assessed by the investigator to be unsuitable for inclusion in this study, such as persons with mental disorders or mental disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vestibule Group; Cryoablation	Device: cryoablation; Treatment of atrial fibrillation with cryoablation catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year atrial fibrillation-free rate	Treatment success rate within 12 months after surgery (ie: no antiarrhythmic drug use, and no atrial fibrillation lasting ≥30s after a 3-month postoperative blank period to a 12-month postoperative follow-up). , AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) events).	1-year
pulmonary vein isolation rate	Immediate success rate of surgery: the percentage of subjects whose pulmonary veins were successfully electrically isolated at the end of surgery (including 30-minute observation time) to the total number of patients undergoing surgery.	Immediate

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (ACTUAL): April 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AF-PACC-CRYO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes