Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation (AF-PACC-CRYO)
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 18 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.
Exclusion Criteria:
- 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;
- Have participated in or are participating in clinical investigators of other drugs or devices within 3 months before enrollment;
- Other conditions assessed by the investigator to be unsuitable for inclusion in this study, such as persons with mental disorders or mental disorders.
Sites / Locations
- Shanghai Tenth People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vestibule Group
Arm Description
Cryoablation
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05311098
First Posted
March 28, 2022
Last Updated
May 20, 2022
Sponsor
Shanghai 10th People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05311098
Brief Title
Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation
Acronym
AF-PACC-CRYO
Official Title
Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vestibule Group
Arm Type
Experimental
Arm Description
Cryoablation
Intervention Type
Device
Intervention Name(s)
cryoablation
Intervention Description
Treatment of atrial fibrillation with cryoablation catheters
Primary Outcome Measure Information:
Title
1-year atrial fibrillation-free rate
Description
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).
Time Frame
1-year
Title
pulmonary vein isolation rate
Description
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.
Time Frame
Immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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.
Exclusion Criteria:
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;
Have participated in or are participating in clinical investigators of other drugs or devices within 3 months before enrollment;
Other conditions assessed by the investigator to be unsuitable for inclusion in this study, such as persons with mental disorders or mental disorders.
Facility Information:
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, M.D.
Phone
+8615000420881
Email
zhangjun_njmu2011@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation
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