SMART China, A Multi-center Clinical Registry Study

NCT02485925 | Completed Phase 4 Results DMC FDA Device

• 1 other identifier: BW-201501
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Keywords

Interventional; Radiofrequency ablation; Paroxysmal Atrial Fibrillation; Catheter ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Patients Where Acute Success Was Achieved

  0.5 hours

• Average Contact Force Per Pulmonary Vein Ablation Procedure

  1 day during procedure

• Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure

  1 day during procedure

• Procedure Time, Ablation Time and Fluoroscopy Time

  1 day during procedure

Study Arms (1)

Treatment group

EXPERIMENTAL

THERMOCOOL® SMARTTOUCH™

Device: THERMOCOOL® SMARTTOUCH™

Interventions

THERMOCOOL® SMARTTOUCH™ DEVICE

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

Also known as: Pulmonary vein isolation

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Related Links

• Sponsor website

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kendra McInnis
• Organization: Biosense Webster, Inc.

kmcinnis@its.jnj.com

949-450-7783

Study Officials

• Congxin Huang

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 30, 2015
• Study Start: July 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: February 4, 2025
• Results First Posted: July 31, 2018

Record last verified: 2025-01