Status:
UNKNOWN
Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation
Lead Sponsor:
Shanghai 10th People's Hospital
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
NA
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-cou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05311098
Start Date
May 1 2022
End Date
May 1 2024
Last Update
May 26 2022
Active Locations (1)
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1
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200072