SMART China, A Multi-center Clinical Registry Study

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: THERMOCOOL® SMARTTOUCH™

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Chaoyang, Beijing, China, 100020
      • Beijing Chao-Yang Hospital
    • Xicheng, Beijing, China, 100037
      • Fu Wai Hospital CAMS&PUMC
  • Hubei
    • Wuchang, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430022
      • Wu Han Asia Heart Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Xuzhou, Jiangsu, China, 221009
      • Xuzhou Central Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital to Nanchang University
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • The First Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110015
      • The General Hospital Of Shenyang Military Region
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qi Lu Hospital of Shandong University
  • Tianjin
    • Heping, Tianjin, China, 300052
      • General Hospital Affiliated to Tianjin Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; THERMOCOOL® SMARTTOUCH™	Device: THERMOCOOL® SMARTTOUCH™; Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device); Other Names: Pulmonary vein isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes	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).	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Where Acute Success Was Achieved	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.	0.5 hours
Average Contact Force Per Pulmonary Vein Ablation Procedure	Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn't have CF data	1 day during procedure
Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure	Percentage of subjects with PV reconnection after the first ablation	1 day during procedure
Procedure Time, Ablation Time and Fluoroscopy Time	Procedure Time, Ablation Time and Fluoroscopy Time in minutes	1 day during procedure

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Principal Investigator: Congxin Huang, Renmin Hospital of Wuhan University

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimated): June 30, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Catheter ablation; Interventional; Radiofrequency ablation; Paroxysmal Atrial Fibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BW-201501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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