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

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05311098
Collaborator
(none)
400
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: cryoablation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vestibule Group

Cryoablation

Device: cryoablation
Treatment of atrial fibrillation with cryoablation catheters

Outcome Measures

Primary Outcome Measures

  1. 1-year atrial fibrillation-free rate [1-year]

    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).

  2. pulmonary vein isolation rate [Immediate]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Tenth People's Hospital Shanghai Shanghai China 200072

Sponsors and Collaborators

  • Shanghai 10th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ya-Wei Xu, Director, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT05311098
Other Study ID Numbers:
  • AF-PACC-CRYO
First Posted:
Apr 5, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of May 26, 2022