Trial Outcomes & Findings for THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS (NCT NCT01639495)
NCT ID: NCT01639495
Last Updated: 2018-05-15
Results Overview
Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures
COMPLETED
PHASE3
148 participants
Day 91-361
2018-05-15
Participant Flow
This study enrolled 148 subjects at 15 clinical sites in the U.S. over the course of approximately 8 months. The first subject was enrolled on July 26, 2012, and the last subject was enrolled on March 18, 2013. The study's last index ablation procedure was on April 24, 2013.
Participant milestones
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
|
|---|---|
|
Overall Study
STARTED
|
148
|
|
Overall Study
Safety Cohort
|
144
|
|
Overall Study
Primary Effectiveness Cohort
|
138
|
|
Overall Study
COMPLETED
|
132
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
|
|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Consented but didn't have study catheter
|
4
|
|
Overall Study
Not meeting inclusion/exclusion criteria
|
4
|
|
Overall Study
No radiofrequency energy applied
|
2
|
Baseline Characteristics
All subjects who signed informed consent.
Baseline characteristics by cohort
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=148 Participants
THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
|
|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants • All subjects who signed informed consent.
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants • All subjects who signed informed consent.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants • All subjects who signed informed consent.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants • All subjects who signed informed consent.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • All subjects who signed informed consent.
|
|
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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
147 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
148 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 91-361Population: 137 Study-eligible subjects with per-protocol procedure. CENSORED: 1 lost to follow-up subject without recurrence
Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=138 Participants
THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
|
|---|---|
|
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias
Primary Effectiveness Cohort
|
60.6 Percentage of participants
Interval 51.9 to 68.8
|
|
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias
Male
|
60.8 Percentage of participants
Interval 50.4 to 70.6
|
|
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias
Female
|
60 Percentage of participants
Interval 43.3 to 75.1
|
PRIMARY outcome
Timeframe: 12 months post procedurePopulation: 144 subjects that had study catheter inserted into their body; INCLUDES study ineligible \& untreated subjects
Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=144 Participants
THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
|
|---|---|
|
Incidence of Primary Adverse Events Within Specified Study Period
Primary Safety Cohort
|
17.4 percentage of subjects with primary AE
Interval 11.6 to 24.6
|
|
Incidence of Primary Adverse Events Within Specified Study Period
Male
|
13.7 percentage of subjects with primary AE
Interval 7.7 to 22.0
|
|
Incidence of Primary Adverse Events Within Specified Study Period
Female
|
26.2 percentage of subjects with primary AE
Interval 13.9 to 42.0
|
SECONDARY outcome
Timeframe: Within 8-30 days post procedurePopulation: Safety cohort, including Enrolled subjects who underwent insertion of the study catheter.
Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=144 Participants
THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
|
|---|---|
|
Peri-procedural Serious Adverse Events
Number of subjects had peri-procedural SAEs
|
2 Number of participants
|
|
Peri-procedural Serious Adverse Events
Possibly procedure related
|
2 Number of participants
|
|
Peri-procedural Serious Adverse Events
Not-related to procedure or device
|
1 Number of participants
|
SECONDARY outcome
Timeframe: 5 hours of procedure timePopulation: Effectiveness cohort, defined as those enrolled subjects who underwent insertion of the study catheter and an AF ablation procedure. Subjects without RF energy delivery will be excluded (i.e. discontinued subjects).
Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=142 Participants
THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
|
|---|---|
|
Percentage of Subjects Achieved Acute Effectiveness
|
97.2 Percentage of participants
Interval 95.6 to 98.2
|
SECONDARY outcome
Timeframe: From 31 days post procedure to month 12Population: Safety cohort, including Enrolled subjects who underwent insertion of the study catheter.
Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure
Outcome measures
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=144 Participants
THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
|
|---|---|
|
Late Onset Serious Adverse Events
Number of subjects had late onset SAEs
|
27 Number of participants
|
|
Late Onset Serious Adverse Events
Procedure related
|
1 Number of participants
|
|
Late Onset Serious Adverse Events
Not-related to procedure or device
|
26 Number of participants
|
Adverse Events
THERMOCOOL® SMARTTOUCH™ Catheter
Serious adverse events
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=144 participants at risk
THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Arrhythmia
|
11.1%
16/144 • Number of events 26 • 12 months post procedure
|
|
Cardiac disorders
Atrial fibrillation
|
2.8%
4/144 • Number of events 4 • 12 months post procedure
|
|
Cardiac disorders
Atrial flutter
|
2.1%
3/144 • Number of events 3 • 12 months post procedure
|
|
Cardiac disorders
Atrioventricular block
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Cardiac disorders
Cardiac failure
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Cardiac failure congestive
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Cardiomyopathy
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Chest pain
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Cardiac disorders
Dyspnoea
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Mitral valve disease
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Palpitations
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Pericardial effusion
|
2.1%
3/144 • Number of events 3 • 12 months post procedure
|
|
Cardiac disorders
Pericarditis
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Cardiac disorders
Pulmonary oedema
|
2.1%
3/144 • Number of events 3 • 12 months post procedure
|
|
Gastrointestinal disorders
Abdominal abscess
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Gastrointestinal disorders
Appendicitis
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
General disorders
Pyrexia
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Infections and infestations
Pneumonia
|
2.8%
4/144 • Number of events 4 • 12 months post procedure
|
|
Infections and infestations
Sepsis
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Renal and urinary disorders
Haematuria
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.69%
1/144 • Number of events 1 • 12 months post procedure
|
|
Vascular disorders
Arteriovenous fistula
|
2.1%
3/144 • Number of events 3 • 12 months post procedure
|
|
Vascular disorders
Haematoma
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Vascular disorders
Hypertension
|
2.1%
3/144 • Number of events 3 • 12 months post procedure
|
Other adverse events
| Measure |
THERMOCOOL® SMARTTOUCH™ Catheter
n=144 participants at risk
THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation
|
|---|---|
|
Cardiac disorders
Fluid overload
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Cardiac disorders
Oedema peripheral
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Cardiac disorders
Palpitations
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Cardiac disorders
Syncope
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Infections and infestations
Sepsis
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Infections and infestations
Sinusitis
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Infections and infestations
Urinary tract infection
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Vascular disorders
Arteriovenous fistula
|
1.4%
2/144 • Number of events 2 • 12 months post procedure
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
3/144 • Number of events 3 • 12 months post procedure
|
|
Cardiac disorders
Chest pain
|
2.1%
3/144 • Number of events 3 • 12 months post procedure
|
|
Renal and urinary disorders
Haematuria
|
2.1%
3/144 • Number of events 3 • 12 months post procedure
|
|
Cardiac disorders
Pericardial effusion
|
2.8%
4/144 • Number of events 4 • 12 months post procedure
|
|
Vascular disorders
Haematoma
|
2.8%
4/144 • Number of events 4 • 12 months post procedure
|
|
Cardiac disorders
Arrhythmia
|
13.2%
19/144 • Number of events 32 • 12 months post procedure
|
Additional Information
Robert Stagg, PhD, Manager, Clinical Franchise
Biosense Webster, Inc.
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