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

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ClinicalTrials.gov Identifier: NCT01385202
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Heart Diseases
Arrhythmia
Atrial Fibrillation
Intervention Device: THERMOCOOL® SMARTTOUCH™ Catheter
Enrollment 172
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.
Pre-assignment Details  
Arm/Group Title THERMOCOOL® SMARTTOUCH™ Catheter
Hide Arm/Group Description THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
Period Title: Overall Study
Started 172 [1]
Study Catheter Inserted 161
Undergoing Ablation 160
Completed 154
Not Completed 18
Reason Not Completed
Lost to Follow-up             6
Not Eligible             11
Withdrawn             1
[1]
Per protocol, enrolled subjects were defined as those who signed inform consent form.
Arm/Group Title THERMOCOOL® SMARTTOUCH™ Catheter
Hide Arm/Group Description THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
Overall Number of Baseline Participants 172
Hide Baseline Analysis Population Description
All enrolled subjects, including all who signed inform consent form.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants
58.8  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
Female
48
  27.9%
Male
124
  72.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   2.3%
White
165
  95.9%
More than one race
0
   0.0%
Unknown or Not Reported
3
   1.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
Hispanic or Latino
4
   2.3%
Not Hispanic or Latino
168
  97.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 172 participants
172
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
Overall Number of Participants Analyzed 114
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70.2
(60.9 to 78.4)
Show Statistical Analysis 1 Hide 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 [Not Specified]
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
Estimation Comments The confidence intervals above are the 95% exact binomial confidence intervals.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection THERMOCOOL® SMARTTOUCH™ Catheter
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Primary effectiveness rate
Estimated Value 74
Confidence Interval (2-Sided) 95%
66 to 82
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety cohort includes all enrolled subjects who had the study catheter inserted.
Arm/Group Title THERMOCOOL® SMARTTOUCH™ Catheter
Hide Arm/Group Description:
THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
Overall Number of Participants Analyzed 161
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients with primary AE
9.9
(5.8 to 15.6)
3.Secondary Outcome
Title Rate of Acute Success
Hide Description Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
Time Frame End of procedure
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 122 38
Measure Type: Number
Unit of Measure: percentage of participants
100 94.7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title THERMOCOOL® SMARTTOUCH™ Catheter
Hide Arm/Group Description THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
All-Cause Mortality
THERMOCOOL® SMARTTOUCH™ Catheter
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
THERMOCOOL® SMARTTOUCH™ Catheter
Affected / at Risk (%) # Events
Total   38/161 (23.60%)    
Cardiac disorders   
ATRIAL FLUTTER   1/161 (0.62%)  1
CARDIAC TAMPONADE   4/161 (2.48%)  5
HEART BLOCK   1/161 (0.62%)  1
HOSPITALIZATION, INTIAL AND PROLONGED   12/161 (7.45%)  17
PAF ABLATION REDO   1/161 (0.62%)  1
PERICARDITIS   3/161 (1.86%)  3
VASOVAGAL SYNCOPE BECAUSE OF LEG CRAMPS   1/161 (0.62%)  1
Gastrointestinal disorders   
DYSPHAGIA   1/161 (0.62%)  1
HOSPITALIZATION, INTIAL AND PROLONGED   1/161 (0.62%)  1
General disorders   
FEVER   1/161 (0.62%)  1
Infections and infestations   
HOSPITALIZATION, INTIAL AND PROLONGED   1/161 (0.62%)  1
PNEUMONIA   1/161 (0.62%)  1
VIRAL INFECTION RESULTING IN HOSPITALIZATION, PHLEBITIS FROM IV   1/161 (0.62%)  1
WBC ELEVATED, ABDOMINAL PAIN, ILEUS AND LOSS OF CAPTURE IN RV LEAD POST-LASER LEAD EXTRACT   1/161 (0.62%)  1
Musculoskeletal and connective tissue disorders   
CHEST PAIN   1/161 (0.62%)  1
HOSPITALIZATION, INTIAL AND PROLONGED   2/161 (1.24%)  2
LEFT KNEE INJURY   1/161 (0.62%)  1
Nervous system disorders   
LEFT ARM PAIN   1/161 (0.62%)  1
LOC   1/161 (0.62%)  1
MIGRAINES   1/161 (0.62%)  1
Renal and urinary disorders   
HOSPITALIZATION, INTIAL AND PROLONGED   1/161 (0.62%)  1
Respiratory, thoracic and mediastinal disorders   
HOSPITALIZATION, INTIAL AND PROLONGED   2/161 (1.24%)  2
LUNG MASS   1/161 (0.62%)  1
Vascular disorders   
HOSPITALIZATION, INTIAL AND PROLONGED   4/161 (2.48%)  4
VASCULAR ACCESS COMPLICATIONS   3/161 (1.86%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
THERMOCOOL® SMARTTOUCH™ Catheter
Affected / at Risk (%) # Events
Total   70/161 (43.48%)    
Blood and lymphatic system disorders   
ANEMIA   1/161 (0.62%)  1
Cardiac disorders   
AF   1/161 (0.62%)  1
AFLUTTER   1/161 (0.62%)  1
AORTIC ROOT DILATION   1/161 (0.62%)  1
ARRHYTHMIA -FLUTTER   1/161 (0.62%)  1
ARRYTHMIA   1/161 (0.62%)  1
ATRIAL FIBRILLATION   1/161 (0.62%)  1
ATRIAL FIBRILLATION RECURRENCE   2/161 (1.24%)  2
ATRIAL FIBRILLATION, FLUTTER   1/161 (0.62%)  1
ATRIAL FLUTTER   2/161 (1.24%)  3
ATRIAL TACHYCARDIA   1/161 (0.62%)  1
BILATERAL LOWER EXTREMITY EDEMA AND PAIN   1/161 (0.62%)  1
BREAKTHROUGH A-FIB   1/161 (0.62%)  1
CARDIOVERSION FOR ATRIAL TACH   1/161 (0.62%)  1
CHEST DISCOMFORT   1/161 (0.62%)  1
EXERTIONAL ANGINA   1/161 (0.62%)  1
HEART RACING, LIGHTHEADED, CHEST PAIN   1/161 (0.62%)  1
HOSPITALIZATION, INTIAL AND PROLONGED   2/161 (1.24%)  2
HYPOTENSION   2/161 (1.24%)  2
NEAR-SYNCOPAL EPISODES   1/161 (0.62%)  1
NEW DIAGNOSIS OF ATYPICAL ATRIAL FLUTTER   1/161 (0.62%)  1
PERICARDIAL EFFUSION   2/161 (1.24%)  2
PERICARDITIS   2/161 (1.24%)  2
PERICARDIUM STAIN   1/161 (0.62%)  1
RAPID ATRIAL FIB   1/161 (0.62%)  1
RAPID ATRIAL FLUTTER   1/161 (0.62%)  1
RECURRENCE AFIB REQUIRING CVS   1/161 (0.62%)  1
RECURRENCE OF AF REQUIRING CARDIOVERSION   2/161 (1.24%)  2
RECURRENCE OF AFIB REQUIRING REPEAT ABLATION   1/161 (0.62%)  1
RECURRENT AF REQUIRING CARDIOVERSION   1/161 (0.62%)  1
REPEAT PULMONARY VEIN ISOLATION   1/161 (0.62%)  1
RIGHT SIDED ATRIAL FLUTTER   1/161 (0.62%)  1
STRONG HEART BEAT   1/161 (0.62%)  1
VASOVAGAL EVENT   1/161 (0.62%)  1
VOLUME OVERLOAD   1/161 (0.62%)  1
Endocrine disorders   
ADRENAL GLAND MASS   1/161 (0.62%)  1
Eye disorders   
BLURRED VISION   1/161 (0.62%)  1
BLURRY VISION, TINNITUS, HEADACHE   1/161 (0.62%)  1
Gastrointestinal disorders   
CHEST PAIN   1/161 (0.62%)  1
DIAHRRHEA / STOMACH VIRUS   1/161 (0.62%)  1
DIARRHEA , GAS   1/161 (0.62%)  1
GERD, TROUBLE SWALLOWING   1/161 (0.62%)  1
HOSPITALIZATION, INTIAL AND PROLONGED   2/161 (1.24%)  2
INTERMITTENT GASTRIC BURNING   1/161 (0.62%)  1
NEW ONSET DIABETES   1/161 (0.62%)  1
STOMACH VIRUS   1/161 (0.62%)  1
General disorders   
FEVER   1/161 (0.62%)  1
INCREASED TEMPERATURE   1/161 (0.62%)  1
WASHED OUT FEELING   1/161 (0.62%)  1
Infections and infestations   
BRONCHITIS   1/161 (0.62%)  1
HOSPITALIZATION, INTIAL AND PROLONGED   1/161 (0.62%)  1
SINUS INFECTION   2/161 (1.24%)  3
SINUSITIS/BRONCHITIS   1/161 (0.62%)  1
UPPER RESPIRATORY INFECTION   2/161 (1.24%)  2
VIRAL INFECTION   2/161 (1.24%)  2
Injury, poisoning and procedural complications   
FALL - DUE TO SLIP   1/161 (0.62%)  1
Musculoskeletal and connective tissue disorders   
ADHESIVE CAPSULITIS OF SHOULDER   1/161 (0.62%)  1
BACK PAIN   1/161 (0.62%)  1
BRONCHITIS   2/161 (1.24%)  2
CHEST PAIN   1/161 (0.62%)  1
EAR INFECTION   1/161 (0.62%)  1
HOSPITALIZATION, INTIAL AND PROLONGED   1/161 (0.62%)  1
LEFT SHOULDER/ARM PAIN   1/161 (0.62%)  1
PARTIAL KNEE REPLACEMENT   1/161 (0.62%)  1
PINCHED NERVES   1/161 (0.62%)  1
PLANTER FASCIITIS   1/161 (0.62%)  1
REPAIR OF BICEP TENDON   1/161 (0.62%)  1
SYNOVIAL OSTEOCHONDROMATOSIS   1/161 (0.62%)  1
UPPER SHOULDER/CERVICAL SPINE PAIN   1/161 (0.62%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BENIGN TUMOR FOUND   1/161 (0.62%)  1
Nervous system disorders   
DIZZINESS   1/161 (0.62%)  1
HEADACHE WITH BLURRED VISION   1/161 (0.62%)  1
MIGRAINE HEADACHE WITH VISUAL FIELD LOSS   1/161 (0.62%)  1
MIGRANE HEADACHE   1/161 (0.62%)  1
PAIN, NUMBNESS -LEFT HAND/FINGERS LOSS OF STRENGTH   1/161 (0.62%)  1
SYNCOPE   1/161 (0.62%)  1
VASCULAR ACCESS COMPLICATIONS   1/161 (0.62%)  1
Psychiatric disorders   
INSOMNIA   1/161 (0.62%)  1
Renal and urinary disorders   
URINARY RETENTION   1/161 (0.62%)  1
Respiratory, thoracic and mediastinal disorders   
CHEST PAIN   1/161 (0.62%)  1
ONGOING EXERTIONAL SHORTNESS OF BREATH   1/161 (0.62%)  1
SHORTNESS OF BREATH   4/161 (2.48%)  4
SOB AND BLOOD TRANSFUSION   1/161 (0.62%)  1
Vascular disorders   
BLEEDING GUMS   1/161 (0.62%)  1
HEMATOMA   2/161 (1.24%)  2
HYPOTENSION   2/161 (1.24%)  2
POSSIBLE HEMATOMA   1/161 (0.62%)  1
RECTAL BLEEDING   1/161 (0.62%)  1
RIGHT GROIN HEMATOMA   1/161 (0.62%)  1
RT GROIN SEROMA/HEMATOMA   1/161 (0.62%)  1
SIDE EFFECTS FROM MEDICATION DOSING   1/161 (0.62%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Robert Stagg, Manager, Clinical Operations
Organization: Biosense Webster, Inc.
Phone: (800) 729-9010 ext 8611
Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01385202     History of Changes
Other Study ID Numbers: Smart-AF
First Submitted: June 27, 2011
First Posted: June 30, 2011
Results First Submitted: December 17, 2014
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015