SMART-SF Radiofrequency Ablation Safety Study

NCT02359890 | Completed Phase 3 Results DMC FDA Device

• 2 other identifiers: SMART-SFSTSF-162
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Atrial Fibrillation

Keywords

Interventional; Radiofrequency ablation; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants With Non-Primary Serious Adverse Events (SAEs)

  Up to 30 days post Procedure

• Percentage of Participants With Acute Success

  End of procedure

• Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL)

  12 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Device: THERMOCOOL® SMARTTOUCH® (RF ablation treatment)

Interventions

THERMOCOOL® SMARTTOUCH® (RF ablation treatment) DEVICE

Radiofrequency Ablation Treatment

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Related 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.

  PMID: 25125294 BACKGROUND

• 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.

  PMID: 24602038 BACKGROUND

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

Limitations and Caveats

Additional data pertaining to this study expected to be submitted in August 2018. Re-monitoring of safety event data is in progress.

Results Point of Contact

• Title: Robert Stagg
• Organization: Biosense Webster

RStagg@its.jnj.com

(800) 729-9010

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 10, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: November 8, 2016
• Last Updated: February 4, 2025
• Results First Posted: October 17, 2017

Record last verified: 2025-01