SMART-SF Radiofrequency Ablation Safety Study

NCT ID: NCT02359890

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2016-11-08

Brief Summary

This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).

Detailed Description

The purpose of this study is to demonstrate the safety of the study device in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.

Conditions

Atrial Fibrillation

Study Design

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

Study Groups

Treatment Group

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

Group Type: EXPERIMENTAL

THERMOCOOL® SMARTTOUCH® (RF ablation treatment)

Intervention Type: DEVICE

Radiofrequency Ablation Treatment

Interventions

THERMOCOOL® SMARTTOUCH® (RF ablation treatment)

Radiofrequency Ablation Treatment

Intervention Type: DEVICE

Other Intervention Names

Pulmonary vein isolation

Eligibility Criteria

Inclusion Criteria

• Symptomatic paroxysmal atrial fibrillation (AF) who have had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment and a physician's note indicating recurrent, self-terminating AF. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip
• Failed at least one antiarrhythmic drug (AAD) (class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerable to the AAD
• Age 18 years or older

Exclusion Criteria

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Previous surgical or catheter ablation for atrial fibrillation
• Amiodarone at any time during the past 3 months
• Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) within the past 2 months
• Any carotid stenting or endarterectomy
• Coronary artery bypass graft (CABG) surgery within the past 6 months
• AF episodes lasting >7 days
• Documented left atrial (LA) thrombus on imaging
• LA size >50 mm
• Left ventricular ejection fraction (LVEF) < 40%
• Contraindication to anticoagulation (heparin or warfarin)
• History of blood clotting or bleeding abnormalities
• MI within the past 2 months
• Documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months
• Rheumatic Heart Disease
• Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
• Unstable angina
• Acute illness or active systemic infection or sepsis
• Diagnosed atrial myxoma
• Presence of implanted implantable cardioverter defibrillator (ICD)
• Significant pulmonary disease, (eg, 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
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
• Enrollment in an investigational study evaluating another device, biologic, or drug
• Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
• Presence of a condition that precludes vascular access
• Life expectancy or other disease processes likely to limit survival to less than 6 months

• 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

References

Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.

Reference Type: BACKGROUND

PMID: 25125294 (View on PubMed)

Oza SR, Hunter TD, Biviano AB, Dandamudi G, Herweg B, Patel AM, Pollak SJ, Wang H, Fishel RS. Acute safety of an open-irrigated ablation catheter with 56-hole porous tip for radiofrequency ablation of paroxysmal atrial fibrillation: analysis from 2 observational registry studies. J Cardiovasc Electrophysiol. 2014 Aug;25(8):852-858. doi: 10.1111/jce.12403. Epub 2014 Apr 9.

Reference Type: BACKGROUND

PMID: 24602038 (View on PubMed)

Related Links

http://BiosenseWebster.com

Sponsor website

Other Identifiers

SMART-SF

Identifier Type: -

Identifier Source: org_study_id

STSF-162

Identifier Type: OTHER

Identifier Source: secondary_id