SMART China, A Multi-center Clinical Registry Study

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485925
• Other study ID #: BW-201501
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2018
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital	Chaoyang	Beijing
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	General Hospital Affiliated to Tianjin Medical University	Heping	Tianjin
China	Qi Lu Hospital of Shandong University	Jinan	Shandong
China	The Second Affiliated Hospital to Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The General Hospital of Shenyang Military Region	Shenyang	Liaoning
China	Renmin Hospital of Wuhan University	Wuchang	Hubei
China	Wu Han Asia Heart Hospital	Wuhan	Hubei
China	Fu Wai Hospital CAMS&PUMC	Xicheng	Beijing
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Procedure Time, Ablation Time and Fluoroscopy Time	Procedure Time, Ablation Time and Fluoroscopy Time in minutes	1 day during procedure

External Links

•   Sponsor website