SMART China, A Multi-center Clinical Registry Study

NCT ID: NCT02485925

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2017-06-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

THERMOCOOL® SMARTTOUCH™

Group Type: EXPERIMENTAL

THERMOCOOL® SMARTTOUCH™

Intervention Type: DEVICE

Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)

Interventions

THERMOCOOL® SMARTTOUCH™

Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)

Intervention Type: DEVICE

Other Intervention Names

Pulmonary vein isolation

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Congxin Huang

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BW-201501

Identifier Type: -

Identifier Source: org_study_id