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SMART-SF Radiofrequency Ablation Safety Study

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Interventional, Radiofrequency ablation, Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Green Hospital
  • Sharp Memorial Hospital
  • Santa Barbara Cottage Hospital
  • Providence Saint John's Health Center / Pacific Heart Institute
  • JFK Medical Center
  • Florida Hospital Orlando
  • Emory Saint Joseph's Hospital
  • Central Baptist Hospital
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Abbott Northwestern Hospital
  • NYU Langone Medical Center
  • Penn-State Milton S Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • Texas Cardiac Arrhythmia Research Foundation - St. David's
  • HeartPlace
  • Memorial Hermann Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Percentage of Participants With Acute Success
Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
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

Full Information

First Posted
February 3, 2015
Last Updated
August 17, 2018
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02359890
Brief Title
SMART-SF Radiofrequency Ablation Safety Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
September 1, 2015 (Actual)
Study Completion Date
November 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Interventional, Radiofrequency ablation, Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Intervention Type
Device
Intervention Name(s)
THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
Other Intervention Name(s)
Pulmonary vein isolation
Intervention Description
Radiofrequency Ablation Treatment
Primary Outcome Measure Information:
Title
Percentage of Participants With Early Onset Primary Adverse Events
Description
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.
Time Frame
Seven days post ablation procedure
Secondary Outcome Measure Information:
Title
Percentage of Participants With Non-Primary Serious Adverse Events (SAEs)
Description
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
Time Frame
Up to 30 days post Procedure
Title
Percentage of Participants With Acute Success
Description
Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
Time Frame
End of procedure
Title
Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL)
Description
The freedom from documented AF/AT/AFL based on electrocardiographic data
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Scripps Green Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Providence Saint John's Health Center / Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Penn-State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation - St. David's
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
HeartPlace
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Facility Name
Memorial Hermann Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25125294
Citation
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.
Results Reference
background
PubMed Identifier
24602038
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.
Results Reference
background

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SMART-SF Radiofrequency Ablation Safety Study

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