Clinical trial NCT02485925: SMART China, A Multi-center Clinical Registry Study
Official title: The Effectiveness and Safety in the Treatment of Circumferential Pulmonary Vein Isolation (CPVI) for Symptomatic Paroxysmal Atrial Fibrillation With THERMOCOOL® SMARTTOUCH™ Catheter in China, A Multi-center Clinical Registry Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Interventional
Radiofrequency ablation
Paroxysmal Atrial Fibrillation
Catheter ablation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. 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
3. Patients with paroxysmal AF eligible for catheter ablation
4. 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)
5. Able and willing to comply with all pre-, post- and follow-up testing and requirements
6. Be able to sign IRB/EC-approved informed consent form

Exclusion Criteria:

1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
2. Previous surgical or catheter ablation for AF
3. 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.
4. Any carotid stenting or endarterectomy.
5. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months)
6. AF episodes lasting longer than 7 days or terminated via cardioversion
7. Documented left atrial thrombus on imaging
8. Uncontrolled heart Failure or New York Heart Association (NYHA) class III or IV
9. Myocardial Infarction within the previous 60 days (2 months)
10. Documented thromboembolic event (including TIA) within the past 12 months
11. Rheumatic heart disease
12. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
13. 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.
14. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
15. Active illness or active systemic infection or sepsis
16. Diagnosed atrial myxoma
17. Unstable angina within the past 60 days (2 months)
18. History of blood clotting or bleeding abnormalities
19. Life expectancy less than 365 days (12 months)
20. Hypertrophic obstructive cardiomyopathy
21. Presence of implanted ICD
22. Contraindication to anticoagulation
23. Contraindication to isoproterenol
24. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation
25. Women who are pregnant and/or breast feeding
26. Presence of a condition that precludes vascular access.
27. Patients presenting contraindications for study catheter(s), as indicated in the respective Instructions For Use
28. Enrollment in an investigational study evaluating another device, biologic, or drug.

Primary outcomes:
measure: Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes
timeFrame: 12 Months
Secondary outcomes:
measure: Percentage of Patients Where Acute Success Was Achieved
timeFrame: 0.5 hours
measure: Average Contact Force Per Pulmonary Vein Ablation Procedure
timeFrame: 1 day during procedure
measure: Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure
timeFrame: 1 day during procedure
measure: Procedure Time, Ablation Time and Fluoroscopy Time
timeFrame: 1 day during procedure
Other outcomes:
Locations:
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Congxin Huang
role: PRINCIPAL_INVESTIGATOR
References: