THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

• Sponsor: Biosense Webster, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01385202
• Collaborator: (none)
• Enrollment: 172
• Locations: 23
• Arm: 1
• Duration (Months): 23
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases; Arrhythmia; Atrial Fibrillation	Device: THERMOCOOL® SMARTTOUCH™ Catheter	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 172 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: THERMOCOOL® SMARTTOUCH™ Catheter	Device: THERMOCOOL® SMARTTOUCH™ Catheter; AF Ablation

Outcome Measures

Primary Outcome Measures

1. The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up [12-months]

   The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).

2. Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events. [7 days of the 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, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.

Secondary Outcome Measures

1. Rate of Acute Success [End of procedure]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have had at least 3 atrial fibrillation episodes within 6 months of this study

• Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes

• 18 years of age or older

Exclusion Criteria:

• Have had previous ablation for atrial fibrillation

• Have take amiodarone within 6 months of this study

• Have had any heart surgery within the last 60 days

• Have had a heart attack within the last 60 days

• Females who are pregnant or breast feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama, Birmingham	Birmingham	Alabama	United States	35294
2	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	Stanford University School of Medicine	Stanford	California	United States	94305
4	Florida Hospital	Orlando	Florida	United States	32803
5	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
6	Loyola University Chicago	Maywood	Illinois	United States	60153
7	University of Kansas Hospitals	Kansas City	Kansas	United States	66160
8	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
9	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
10	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
11	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
12	Park Nicollet Institute	Minneapolis	Minnesota	United States	55416
13	Mayo Clinic	Rochester	Minnesota	United States	55902
14	The Valley Hospital	Ridgewood	New Jersey	United States	07450
15	Mount Sinai School of Medicine	New York	New York	United States	10029
16	Duke University Medical Center	Durham	North Carolina	United States	27710
17	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
18	Ohio State University	Columbus	Ohio	United States	43210
19	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
20	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
21	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	United States	78705
22	Inova Fairfax Hospital	Fairfax	Virginia	United States	22031
23	Virginia Commonwealth University	Richmond	Virginia	United States	23219

Sponsors and Collaborators

• Biosense Webster, Inc.

Investigators

• Study Chair: Andrea Natale, MD, Texas Cardiac Arrhythmia Research
• Study Chair: David J Wilber, MD, Loyola University
• Study Chair: Francis E Marchlinski, MD, University of Pennsylvania
• Study Chair: Douglas L Packer, MD, Mayo Clinic
• Study Chair: Hiroshi Nakagawa, MD, Ph.D., University of Oklahoma
• Study Chair: Hans Kottkamp, MD, University Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT01385202
• Other Study ID Numbers: Smart-AF
• First Posted: Jun 30, 2011
• Last Update Posted: Jan 26, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Biosense Webster, Inc.: Atrial Fibrillation; Paroxysmal Atrial Fibrillation
• Additional relevant MeSH terms: Atrial Fibrillation; Heart Diseases

Study Results

Participant Flow

Recruitment Details	The first subject was enrolled on June 02, 2011. Twenty-one (21) sites enrolled subjects. Last patient enrolled on December 22, 2011. Last procedure on December 29, 2011.

Arm/Group Title	THERMOCOOL® SMARTTOUCH™ Catheter
Arm/Group Description	THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
Period Title: Overall Study
STARTED	172
Study Catheter Inserted	161
Undergoing Ablation	160
COMPLETED	154
NOT COMPLETED	18

Baseline Characteristics

Arm/Group Title	THERMOCOOL® SMARTTOUCH™ Catheter
Arm/Group Description	THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
Overall Participants	172
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58.8 (11.0)
Sex: Female, Male (Count of Participants)
Female	48 27.9%
Male	124 72.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 2.3%
White	165 95.9%
More than one race	0 0%
Unknown or Not Reported	3 1.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 2.3%
Not Hispanic or Latino	168 97.7%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	172 100%

Outcome Measures

1. Primary Outcome

Title	The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up
Description	The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).
Time Frame	12-months

Outcome Measure Data

Analysis Population Description

Primary Effectiveness Cohort includes those enrolled who met the inclusion/exclusion criteria and had undergone insertion of the study catheter and Atrial Fibrillation (AF) ablation procedure, excluding those with radiofrequency energy not delivered, with calibration roll-in, and with only non-study arrhythmia.

Arm/Group Title	THERMOCOOL® SMARTTOUCH™ Catheter
Arm/Group Description	THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
Measure Participants	114
Number (95% Confidence Interval) [percentage of participants]	70.2 40.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THERMOCOOL® SMARTTOUCH™ Catheter
	Comments	The null hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be less than or equal to the pre-determined performance criterion of 50%. The alternative hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be greater than the pre-determined performance criterion of 50%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	In the worst-case scenario analysis, over seventy-percent (70.2%, 80/114) of the primary effectiveness cohort (PEC) were free from documented symptomatic atrial tachyarrhythmias during their effectiveness evaluation period.
	Method	Fisher Exact
	Comments	The lower bound of the 95% confidence intervals was 60.9%, significantly higher than the pre-determined performance goal of 50% (p<0.0001).
Method of Estimation	Estimation Parameter	Primary effectiveness rate
	Estimated Value	70.2
	Confidence Interval	(2-Sided) 95%; 60.9 to 78.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	The confidence intervals above are the 95% exact binomial confidence intervals.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	THERMOCOOL® SMARTTOUCH™ Catheter
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Primary effectiveness rate
	Estimated Value	74
	Confidence Interval	(2-Sided) 95%; 66 to 82
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95% confidence intervals above were calculated using the Kaplan-Meier (KM) method.

2. Primary Outcome

Title	Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.
Description	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, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.
Time Frame	7 days of the AF ablation procedure

Outcome Measure Data

Analysis Population Description

Safety cohort includes all enrolled subjects who had the study catheter inserted.

Arm/Group Title	THERMOCOOL® SMARTTOUCH™ Catheter
Arm/Group Description	THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
Measure Participants	161
Number (95% Confidence Interval) [Percentage of patients with primary AE]	9.9

3. Secondary Outcome

Title	Rate of Acute Success
Description	Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
Time Frame	End of procedure

Outcome Measure Data

Analysis Population Description

The analysis population for this endpoint includes two groups; a): Calibration Roll-in subjects who were prospectively identified prior to the study procedure and b) the Effectiveness Cohort. Both groups underwent an AF ablation procedure with the study catheter.

Arm/Group Title	THERMOCOOL® SMARTTOUCH™ Catheter-Effective Cohort	Calibration Roll-in
Arm/Group Description	THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter.	Calibration roll-in case(s) is intended to calibrate an investigator's tactile feel, catheter manipulation technique, and use of other surrogate measures (electrogram signal, impedance, etc.) during the procedure.
Measure Participants	122	38
Number [percentage of participants]	100 58.1%	94.7 NaN

Adverse Events

Arm/Group Title	THERMOCOOL® SMARTTOUCH™ Catheter
Arm/Group Description	THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
All Cause Mortality
	THERMOCOOL® SMARTTOUCH™ Catheter
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	THERMOCOOL® SMARTTOUCH™ Catheter
	Affected / at Risk (%)	# Events
Total	38/161 (23.6%)
Cardiac disorders
ATRIAL FLUTTER	1/161 (0.6%)	1
CARDIAC TAMPONADE	4/161 (2.5%)	5
HEART BLOCK	1/161 (0.6%)	1
HOSPITALIZATION, INTIAL AND PROLONGED	12/161 (7.5%)	17
PAF ABLATION REDO	1/161 (0.6%)	1
PERICARDITIS	3/161 (1.9%)	3
VASOVAGAL SYNCOPE BECAUSE OF LEG CRAMPS	1/161 (0.6%)	1
Gastrointestinal disorders
DYSPHAGIA	1/161 (0.6%)	1
HOSPITALIZATION, INTIAL AND PROLONGED	1/161 (0.6%)	1
General disorders
FEVER	1/161 (0.6%)	1
Infections and infestations
HOSPITALIZATION, INTIAL AND PROLONGED	1/161 (0.6%)	1
PNEUMONIA	1/161 (0.6%)	1
VIRAL INFECTION RESULTING IN HOSPITALIZATION, PHLEBITIS FROM IV	1/161 (0.6%)	1
WBC ELEVATED, ABDOMINAL PAIN, ILEUS AND LOSS OF CAPTURE IN RV LEAD POST-LASER LEAD EXTRACT	1/161 (0.6%)	1
Musculoskeletal and connective tissue disorders
CHEST PAIN	1/161 (0.6%)	1
HOSPITALIZATION, INTIAL AND PROLONGED	2/161 (1.2%)	2
LEFT KNEE INJURY	1/161 (0.6%)	1
Nervous system disorders
LEFT ARM PAIN	1/161 (0.6%)	1
LOC	1/161 (0.6%)	1
MIGRAINES	1/161 (0.6%)	1
Renal and urinary disorders
HOSPITALIZATION, INTIAL AND PROLONGED	1/161 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
HOSPITALIZATION, INTIAL AND PROLONGED	2/161 (1.2%)	2
LUNG MASS	1/161 (0.6%)	1
Vascular disorders
HOSPITALIZATION, INTIAL AND PROLONGED	4/161 (2.5%)	4
VASCULAR ACCESS COMPLICATIONS	3/161 (1.9%)	3
Other (Not Including Serious) Adverse Events
	THERMOCOOL® SMARTTOUCH™ Catheter
	Affected / at Risk (%)	# Events
Total	70/161 (43.5%)
Blood and lymphatic system disorders
ANEMIA	1/161 (0.6%)	1
Cardiac disorders
AF	1/161 (0.6%)	1
AFLUTTER	1/161 (0.6%)	1
AORTIC ROOT DILATION	1/161 (0.6%)	1
ARRHYTHMIA -FLUTTER	1/161 (0.6%)	1
ARRYTHMIA	1/161 (0.6%)	1
ATRIAL FIBRILLATION	1/161 (0.6%)	1
ATRIAL FIBRILLATION RECURRENCE	2/161 (1.2%)	2
ATRIAL FIBRILLATION, FLUTTER	1/161 (0.6%)	1
ATRIAL FLUTTER	2/161 (1.2%)	3
ATRIAL TACHYCARDIA	1/161 (0.6%)	1
BILATERAL LOWER EXTREMITY EDEMA AND PAIN	1/161 (0.6%)	1
BREAKTHROUGH A-FIB	1/161 (0.6%)	1
CARDIOVERSION FOR ATRIAL TACH	1/161 (0.6%)	1
CHEST DISCOMFORT	1/161 (0.6%)	1
EXERTIONAL ANGINA	1/161 (0.6%)	1
HEART RACING, LIGHTHEADED, CHEST PAIN	1/161 (0.6%)	1
HOSPITALIZATION, INTIAL AND PROLONGED	2/161 (1.2%)	2
HYPOTENSION	2/161 (1.2%)	2
NEAR-SYNCOPAL EPISODES	1/161 (0.6%)	1
NEW DIAGNOSIS OF ATYPICAL ATRIAL FLUTTER	1/161 (0.6%)	1
PERICARDIAL EFFUSION	2/161 (1.2%)	2
PERICARDITIS	2/161 (1.2%)	2
PERICARDIUM STAIN	1/161 (0.6%)	1
RAPID ATRIAL FIB	1/161 (0.6%)	1
RAPID ATRIAL FLUTTER	1/161 (0.6%)	1
RECURRENCE AFIB REQUIRING CVS	1/161 (0.6%)	1
RECURRENCE OF AF REQUIRING CARDIOVERSION	2/161 (1.2%)	2
RECURRENCE OF AFIB REQUIRING REPEAT ABLATION	1/161 (0.6%)	1
RECURRENT AF REQUIRING CARDIOVERSION	1/161 (0.6%)	1
REPEAT PULMONARY VEIN ISOLATION	1/161 (0.6%)	1
RIGHT SIDED ATRIAL FLUTTER	1/161 (0.6%)	1
STRONG HEART BEAT	1/161 (0.6%)	1
VASOVAGAL EVENT	1/161 (0.6%)	1
VOLUME OVERLOAD	1/161 (0.6%)	1
Endocrine disorders
ADRENAL GLAND MASS	1/161 (0.6%)	1
Eye disorders
BLURRED VISION	1/161 (0.6%)	1
BLURRY VISION, TINNITUS, HEADACHE	1/161 (0.6%)	1
Gastrointestinal disorders
CHEST PAIN	1/161 (0.6%)	1
DIAHRRHEA / STOMACH VIRUS	1/161 (0.6%)	1
DIARRHEA , GAS	1/161 (0.6%)	1
GERD, TROUBLE SWALLOWING	1/161 (0.6%)	1
HOSPITALIZATION, INTIAL AND PROLONGED	2/161 (1.2%)	2
INTERMITTENT GASTRIC BURNING	1/161 (0.6%)	1
NEW ONSET DIABETES	1/161 (0.6%)	1
STOMACH VIRUS	1/161 (0.6%)	1
General disorders
FEVER	1/161 (0.6%)	1
INCREASED TEMPERATURE	1/161 (0.6%)	1
WASHED OUT FEELING	1/161 (0.6%)	1
Infections and infestations
BRONCHITIS	1/161 (0.6%)	1
HOSPITALIZATION, INTIAL AND PROLONGED	1/161 (0.6%)	1
SINUS INFECTION	2/161 (1.2%)	3
SINUSITIS/BRONCHITIS	1/161 (0.6%)	1
UPPER RESPIRATORY INFECTION	2/161 (1.2%)	2
VIRAL INFECTION	2/161 (1.2%)	2
Injury, poisoning and procedural complications
FALL - DUE TO SLIP	1/161 (0.6%)	1
Musculoskeletal and connective tissue disorders
ADHESIVE CAPSULITIS OF SHOULDER	1/161 (0.6%)	1
BACK PAIN	1/161 (0.6%)	1
BRONCHITIS	2/161 (1.2%)	2
CHEST PAIN	1/161 (0.6%)	1
EAR INFECTION	1/161 (0.6%)	1
HOSPITALIZATION, INTIAL AND PROLONGED	1/161 (0.6%)	1
LEFT SHOULDER/ARM PAIN	1/161 (0.6%)	1
PARTIAL KNEE REPLACEMENT	1/161 (0.6%)	1
PINCHED NERVES	1/161 (0.6%)	1
PLANTER FASCIITIS	1/161 (0.6%)	1
REPAIR OF BICEP TENDON	1/161 (0.6%)	1
SYNOVIAL OSTEOCHONDROMATOSIS	1/161 (0.6%)	1
UPPER SHOULDER/CERVICAL SPINE PAIN	1/161 (0.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN TUMOR FOUND	1/161 (0.6%)	1
Nervous system disorders
DIZZINESS	1/161 (0.6%)	1
HEADACHE WITH BLURRED VISION	1/161 (0.6%)	1
MIGRAINE HEADACHE WITH VISUAL FIELD LOSS	1/161 (0.6%)	1
MIGRANE HEADACHE	1/161 (0.6%)	1
PAIN, NUMBNESS -LEFT HAND/FINGERS LOSS OF STRENGTH	1/161 (0.6%)	1
SYNCOPE	1/161 (0.6%)	1
VASCULAR ACCESS COMPLICATIONS	1/161 (0.6%)	1
Psychiatric disorders
INSOMNIA	1/161 (0.6%)	1
Renal and urinary disorders
URINARY RETENTION	1/161 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
CHEST PAIN	1/161 (0.6%)	1
ONGOING EXERTIONAL SHORTNESS OF BREATH	1/161 (0.6%)	1
SHORTNESS OF BREATH	4/161 (2.5%)	4
SOB AND BLOOD TRANSFUSION	1/161 (0.6%)	1
Vascular disorders
BLEEDING GUMS	1/161 (0.6%)	1
HEMATOMA	2/161 (1.2%)	2
HYPOTENSION	2/161 (1.2%)	2
POSSIBLE HEMATOMA	1/161 (0.6%)	1
RECTAL BLEEDING	1/161 (0.6%)	1
RIGHT GROIN HEMATOMA	1/161 (0.6%)	1
RT GROIN SEROMA/HEMATOMA	1/161 (0.6%)	1
SIDE EFFECTS FROM MEDICATION DOSING	1/161 (0.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.