SMART-SF Radiofrequency Ablation Safety Study

Atrial Fibrillation Clinical Trial

Official title:

Prospective Safety Assessment of the THERMOCOOL® SMARTTOUCH® SF Family of Contact Force Sensing Catheters for the Radiofrequency Ablation Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359890
• Other study ID #: SMART-SF
• Secondary ID: STSF-162
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2015
• Est. completion date: November 8, 2016

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 8, 2016
• Est. primary completion date: September 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
Radiofrequency Ablation Treatment

Locations

Country	Name	City	State
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	JFK Medical Center	Atlantis	Florida
United States	Texas Cardiac Arrhythmia Research Foundation - St. David's	Austin	Texas
United States	HeartPlace	Bedford	Texas
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Penn-State Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Memorial Hermann Medical Center	Houston	Texas
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	NYU Langone Medical Center	New York	New York
United States	Florida Hospital Orlando	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Scripps Green Hospital	San Diego	California
United States	Sharp Memorial Hospital	San Diego	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Providence Saint John's Health Center / Pacific Heart Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Early Onset Primary Adverse Events	Early onset is defined as within 7 days of the atrial fibrillation (AF) ablation procedure. Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade / Perforation, Pneumothorax, Major Vascular Access Complications / Bleeding, Pulmonary edema (Respiratory Insufficiency), and Heart block.	Seven days post ablation procedure
Secondary	Percentage of Participants With Non-Primary Serious Adverse Events (SAEs)	This secondary safety endpoint includes non-primary serious adverse events (SAEs) within 7 days post-procedure and serious adverse events from 8 days to 30 days post-procedure	Up to 30 days post Procedure
Secondary	Percentage of Participants With Acute Success	Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).	End of procedure
Secondary	Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL)	The freedom from documented AF/AT/AFL based on electrocardiographic data	12 months

External Links

•   Sponsor website