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

NCT05311098 | Unknown DMC FDA Device

• 1 other identifier: AF-PACC-CRYO
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Vestibule Group

EXPERIMENTAL

Cryoablation

Device: cryoablation

Interventions

cryoablation DEVICE

Treatment of atrial fibrillation with cryoablation catheters

Vestibule 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:

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

You may not qualify if:

• Echocardiography shows that the left atrium diameter is greater than or equal to 45mm;
• Preoperative CT or esophageal echocardiography suggests that there is a thrombus in the left atrium/left atrial appendage;
• Those who have undergone left atrial ablation or left atrial surgery;
• Those who have received simple left atrial appendage occlusion;
• New York heart function class (NYHA) class III or IV congestive heart failure or LVEF (%) less than 40%;
• Those who have undergone valve repair;
• Preoperative electrocardiogram or Holter confirmed the presence of typical atrial flutter or other supraventricular tachycardia (holding The duration is greater than 30 s);
• Secondary atrial fibrillation, including uncontrolled hyperthyroidism, acute alcoholism, cardiac surgery postoperative atrial fibrillation, etc.;
• History of acute coronary events or percutaneous coronary stent intervention within 6 months before enrollment;
• Those with a history of cardioverter-defibrillator (ICD) implantation or a history of cardiac resynchronization therapy (CRT);
• History of stroke or transient ischemic attack within 6 months before enrollment;
• Those with obvious bleeding tendency who cannot receive postoperative systemic anticoagulation;
• Severe structural heart disease, including moderate to severe mitral insufficiency or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.;
• Combined with other serious diseases, the life expectancy is less than 12 months;
• Women who are pregnant, breastfeeding and planning to become pregnant;

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)