Trial Outcomes & Findings for THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (NCT NCT01385202)
NCT ID: NCT01385202
Last Updated: 2025-02-04
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
172 participants
Primary outcome timeframe
12-months
Results posted on
2025-02-04
Participant Flow
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.
Participant milestones
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
|
|---|---|
|
Overall Study
STARTED
|
172
|
|
Overall Study
Study Catheter Inserted
|
161
|
|
Overall Study
Undergoing Ablation
|
160
|
|
Overall Study
COMPLETED
|
154
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
|
|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Not Eligible
|
11
|
|
Overall Study
Withdrawn
|
1
|
Baseline Characteristics
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=172 Participants
THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
|
|---|---|
|
Age, Continuous
|
58.8 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
172 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-monthsPopulation: 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.
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).
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=114 Participants
THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
|
Calibration Roll-in
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.
|
|---|---|---|
|
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
|
70.2 percentage of participants
Interval 60.9 to 78.4
|
—
|
PRIMARY outcome
Timeframe: 7 days of the AF ablation procedurePopulation: Safety cohort includes all enrolled subjects who had the study catheter inserted.
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.
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=161 Participants
THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
|
Calibration Roll-in
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.
|
|---|---|---|
|
Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.
|
9.9 Percentage of patients with primary AE
Interval 5.8 to 15.6
|
—
|
SECONDARY outcome
Timeframe: End of procedurePopulation: 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.
Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=122 Participants
THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
|
Calibration Roll-in
n=38 Participants
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.
|
|---|---|---|
|
Rate of Acute Success
|
100 percentage of participants
|
94.7 percentage of participants
|
Adverse Events
THERMOCOOL® SMARTTOUCH™ Catheter
Serious events: 38 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=161 participants at risk
THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
|
|---|---|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
2.5%
4/161 • Number of events 5
|
|
Cardiac disorders
HEART BLOCK
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
HOSPITALIZATION, INTIAL AND PROLONGED
|
7.5%
12/161 • Number of events 17
|
|
Cardiac disorders
PAF ABLATION REDO
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
PERICARDITIS
|
1.9%
3/161 • Number of events 3
|
|
Cardiac disorders
VASOVAGAL SYNCOPE BECAUSE OF LEG CRAMPS
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
HOSPITALIZATION, INTIAL AND PROLONGED
|
0.62%
1/161 • Number of events 1
|
|
General disorders
FEVER
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
HOSPITALIZATION, INTIAL AND PROLONGED
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
VIRAL INFECTION RESULTING IN HOSPITALIZATION, PHLEBITIS FROM IV
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
WBC ELEVATED, ABDOMINAL PAIN, ILEUS AND LOSS OF CAPTURE IN RV LEAD POST-LASER LEAD EXTRACT
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
CHEST PAIN
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
HOSPITALIZATION, INTIAL AND PROLONGED
|
1.2%
2/161 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
LEFT KNEE INJURY
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
LEFT ARM PAIN
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
LOC
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
MIGRAINES
|
0.62%
1/161 • Number of events 1
|
|
Renal and urinary disorders
HOSPITALIZATION, INTIAL AND PROLONGED
|
0.62%
1/161 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HOSPITALIZATION, INTIAL AND PROLONGED
|
1.2%
2/161 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
LUNG MASS
|
0.62%
1/161 • Number of events 1
|
|
Vascular disorders
HOSPITALIZATION, INTIAL AND PROLONGED
|
2.5%
4/161 • Number of events 4
|
|
Vascular disorders
VASCULAR ACCESS COMPLICATIONS
|
1.9%
3/161 • Number of events 3
|
Other adverse events
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=161 participants at risk
THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
AF
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
AFLUTTER
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
AORTIC ROOT DILATION
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
ARRHYTHMIA -FLUTTER
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
ARRYTHMIA
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
ATRIAL FIBRILLATION RECURRENCE
|
1.2%
2/161 • Number of events 2
|
|
Cardiac disorders
ATRIAL FIBRILLATION, FLUTTER
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
ATRIAL FLUTTER
|
1.2%
2/161 • Number of events 3
|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
BILATERAL LOWER EXTREMITY EDEMA AND PAIN
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
BREAKTHROUGH A-FIB
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
CARDIOVERSION FOR ATRIAL TACH
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
CHEST DISCOMFORT
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
EXERTIONAL ANGINA
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
HEART RACING, LIGHTHEADED, CHEST PAIN
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
HOSPITALIZATION, INTIAL AND PROLONGED
|
1.2%
2/161 • Number of events 2
|
|
Cardiac disorders
HYPOTENSION
|
1.2%
2/161 • Number of events 2
|
|
Cardiac disorders
NEAR-SYNCOPAL EPISODES
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
NEW DIAGNOSIS OF ATYPICAL ATRIAL FLUTTER
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.2%
2/161 • Number of events 2
|
|
Cardiac disorders
PERICARDITIS
|
1.2%
2/161 • Number of events 2
|
|
Cardiac disorders
PERICARDIUM STAIN
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
RAPID ATRIAL FIB
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
RAPID ATRIAL FLUTTER
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
RECURRENCE AFIB REQUIRING CVS
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
RECURRENCE OF AF REQUIRING CARDIOVERSION
|
1.2%
2/161 • Number of events 2
|
|
Cardiac disorders
RECURRENCE OF AFIB REQUIRING REPEAT ABLATION
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
RECURRENT AF REQUIRING CARDIOVERSION
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
REPEAT PULMONARY VEIN ISOLATION
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
RIGHT SIDED ATRIAL FLUTTER
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
STRONG HEART BEAT
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
VASOVAGAL EVENT
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
VOLUME OVERLOAD
|
0.62%
1/161 • Number of events 1
|
|
Endocrine disorders
ADRENAL GLAND MASS
|
0.62%
1/161 • Number of events 1
|
|
Eye disorders
BLURRED VISION
|
0.62%
1/161 • Number of events 1
|
|
Eye disorders
BLURRY VISION, TINNITUS, HEADACHE
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
CHEST PAIN
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
DIAHRRHEA / STOMACH VIRUS
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHEA , GAS
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
GERD, TROUBLE SWALLOWING
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
HOSPITALIZATION, INTIAL AND PROLONGED
|
1.2%
2/161 • Number of events 2
|
|
Gastrointestinal disorders
INTERMITTENT GASTRIC BURNING
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
NEW ONSET DIABETES
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
STOMACH VIRUS
|
0.62%
1/161 • Number of events 1
|
|
General disorders
FEVER
|
0.62%
1/161 • Number of events 1
|
|
General disorders
INCREASED TEMPERATURE
|
0.62%
1/161 • Number of events 1
|
|
General disorders
WASHED OUT FEELING
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
BRONCHITIS
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
HOSPITALIZATION, INTIAL AND PROLONGED
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
SINUS INFECTION
|
1.2%
2/161 • Number of events 3
|
|
Infections and infestations
SINUSITIS/BRONCHITIS
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
1.2%
2/161 • Number of events 2
|
|
Infections and infestations
VIRAL INFECTION
|
1.2%
2/161 • Number of events 2
|
|
Injury, poisoning and procedural complications
FALL - DUE TO SLIP
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ADHESIVE CAPSULITIS OF SHOULDER
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BRONCHITIS
|
1.2%
2/161 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
CHEST PAIN
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
EAR INFECTION
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
HOSPITALIZATION, INTIAL AND PROLONGED
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER/ARM PAIN
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PARTIAL KNEE REPLACEMENT
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PINCHED NERVES
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PLANTER FASCIITIS
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
REPAIR OF BICEP TENDON
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL OSTEOCHONDROMATOSIS
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
UPPER SHOULDER/CERVICAL SPINE PAIN
|
0.62%
1/161 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN TUMOR FOUND
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
DIZZINESS
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
HEADACHE WITH BLURRED VISION
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
MIGRAINE HEADACHE WITH VISUAL FIELD LOSS
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
MIGRANE HEADACHE
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
PAIN, NUMBNESS -LEFT HAND/FINGERS LOSS OF STRENGTH
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
VASCULAR ACCESS COMPLICATIONS
|
0.62%
1/161 • Number of events 1
|
|
Psychiatric disorders
INSOMNIA
|
0.62%
1/161 • Number of events 1
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.62%
1/161 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
CHEST PAIN
|
0.62%
1/161 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ONGOING EXERTIONAL SHORTNESS OF BREATH
|
0.62%
1/161 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
2.5%
4/161 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
SOB AND BLOOD TRANSFUSION
|
0.62%
1/161 • Number of events 1
|
|
Vascular disorders
BLEEDING GUMS
|
0.62%
1/161 • Number of events 1
|
|
Vascular disorders
HEMATOMA
|
1.2%
2/161 • Number of events 2
|
|
Vascular disorders
HYPOTENSION
|
1.2%
2/161 • Number of events 2
|
|
Vascular disorders
POSSIBLE HEMATOMA
|
0.62%
1/161 • Number of events 1
|
|
Vascular disorders
RECTAL BLEEDING
|
0.62%
1/161 • Number of events 1
|
|
Vascular disorders
RIGHT GROIN HEMATOMA
|
0.62%
1/161 • Number of events 1
|
|
Vascular disorders
RT GROIN SEROMA/HEMATOMA
|
0.62%
1/161 • Number of events 1
|
|
Vascular disorders
SIDE EFFECTS FROM MEDICATION DOSING
|
0.62%
1/161 • Number of events 1
|
Additional Information
Robert Stagg, Manager, Clinical Operations
Biosense Webster, Inc.
Phone: (800) 729-9010
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER