SMART China, A Multi-center Clinical Registry Study
- Conditions
- Atrial Fibrillation
- Interventions
- Device: THERMOCOOL® SMARTTOUCH™
- Registration Number
- NCT02485925
- Lead Sponsor
- Biosense Webster, Inc.
- Brief Summary
This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
- Detailed Description
The purpose of this study is to assess the effectiveness and safety of the THERMOCOOL® SMARTTOUCH™ catheter in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) undergoing CPVI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Age 18 years or older
- Failure of at least one antiarrhythmic drug (AAD) for AF (class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD
- Patients with paroxysmal AF eligible for catheter ablation
- Patients with symptomatic PAF who have had at least one documented AF episode in the twelve (12) months prior to enrollment. Documentation may include but is not limited to electrocardiogram (ECG), Holter monitor (HM) or transtelephonic monitor (TTM)
- Able and willing to comply with all pre-, post- and follow-up testing and requirements
- Be able to sign IRB/EC-approved informed consent form
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous surgical or catheter ablation for AF
- Any PCI, cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a prosthetic valve) within the past 2 months.
- Any carotid stenting or endarterectomy.
- Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months)
- AF episodes lasting longer than 7 days or terminated via cardioversion
- Documented left atrial thrombus on imaging
- Uncontrolled heart Failure or New York Heart Association (NYHA) class III or IV
- Myocardial Infarction within the previous 60 days (2 months)
- Documented thromboembolic event (including TIA) within the past 12 months
- Rheumatic heart disease
- Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
- Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Active illness or active systemic infection or sepsis
- Diagnosed atrial myxoma
- Unstable angina within the past 60 days (2 months)
- History of blood clotting or bleeding abnormalities
- Life expectancy less than 365 days (12 months)
- Hypertrophic obstructive cardiomyopathy
- Presence of implanted ICD
- Contraindication to anticoagulation
- Contraindication to isoproterenol
- Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation
- Women who are pregnant and/or breast feeding
- Presence of a condition that precludes vascular access.
- Patients presenting contraindications for study catheter(s), as indicated in the respective Instructions For Use
- Enrollment in an investigational study evaluating another device, biologic, or drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group THERMOCOOL® SMARTTOUCH™ THERMOCOOL® SMARTTOUCH™
- Primary Outcome Measures
Name Time Method Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes 12 Months The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period).
- Secondary Outcome Measures
Name Time Method Percentage of Patients Where Acute Success Was Achieved 0.5 hours Confirmation of entrance block in all pulmonary veins (PVs) with an isoproterenol intravenous challenge 0.5h post procedure. Exit Block is optional for this study.
Average Contact Force Per Pulmonary Vein Ablation Procedure 1 day during procedure Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn't have CF data
Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure 1 day during procedure Percentage of subjects with PV reconnection after the first ablation
Procedure Time, Ablation Time and Fluoroscopy Time 1 day during procedure Procedure Time, Ablation Time and Fluoroscopy Time in minutes
Trial Locations
- Locations (12)
Wu Han Asia Heart Hospital
🇨🇳Wuhan, Hubei, China
The General Hospital of Shenyang Military Region
🇨🇳Shenyang, Liaoning, China
Beijing Chao-Yang Hospital
🇨🇳Chaoyang, Beijing, China
Fu Wai Hospital CAMS&PUMC
🇨🇳Xicheng, Beijing, China
Renmin Hospital of Wuhan University
🇨🇳Wuchang, Hubei, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital to Nanchang University
🇨🇳Nanchang, Jiangxi, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Qi Lu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
General Hospital Affiliated to Tianjin Medical University
🇨🇳Heping, Tianjin, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China