Trial Outcomes & Findings for NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation (NCT NCT00116428)
NCT ID: NCT00116428
Last Updated: 2017-10-24
Results Overview
Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
167 participants
Primary outcome timeframe
The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.
Results posted on
2017-10-24
Participant Flow
This pivotal study was closed to enrollment on October 12, 2007 with a total of 167 subjects enrolled at 19 investigational sites (15 US and 4 outside US).
Participant milestones
| Measure |
NAVISTAR® THERMOCOOL® Catheter
Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
Antiarrhythmic Drug
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
61
|
|
Overall Study
Underwent Study Ablation Procedure
|
103
|
36
|
|
Overall Study
COMPLETED
|
103
|
56
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
NAVISTAR® THERMOCOOL® Catheter
Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
Antiarrhythmic Drug
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Did not meet inclusion criteria
|
1
|
0
|
Baseline Characteristics
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
NAVISTAR® THERMOCOOL® Catheter
n=106 Participants
Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
Antiarrhythmic Drug
n=61 Participants
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
103 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Arab ethnicity
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
17 participants
n=5 Participants
|
10 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
31 participants
n=5 Participants
|
19 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
24 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Number of documented symptomatic Atrial Fibrillation episodes
|
62.3 Number of episodes
STANDARD_DEVIATION 89.2 • n=5 Participants
|
64.9 Number of episodes
STANDARD_DEVIATION 98.0 • n=7 Participants
|
63.24 Number of episodes
STANDARD_DEVIATION 93.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.
Outcome measures
| Measure |
NAVISTAR® THERMOCOOL® Catheter
n=106 Participants
Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
Antiarrhythmic Drug
n=61 Participants
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
|
Antiarrhythmic Drug
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
|
|---|---|---|---|
|
The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)
|
66 Percentage of participants
|
16 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days of Ablation ProcedurePopulation: Analysis population includes those enrolled subjects undergoing a study ablation procedure. A total of 139 underwent the procedure, including 36 AAD (control) group subjects who underwent the procedure after failing the effectiveness endpoint. The remaining 25 AAD (control) subjects didn't have the ablation procedure.
Catheter-related 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,hospitalization (initial and prolonged), and heart block.
Outcome measures
| Measure |
NAVISTAR® THERMOCOOL® Catheter
n=139 Participants
Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
Antiarrhythmic Drug
n=25 Participants
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
|
Antiarrhythmic Drug
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
|
|---|---|---|---|
|
The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events
|
10.1 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: 90 days post study procedurePopulation: This analysis population is based on the first study ablation procedure.
Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.
Outcome measures
| Measure |
NAVISTAR® THERMOCOOL® Catheter
n=103 Participants
Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
Antiarrhythmic Drug
n=36 Participants
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
|
Antiarrhythmic Drug
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
|
|---|---|---|---|
|
The Percentage of Subjects Who Achieved Acute Success.
|
100 Percentage of participants
|
94 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: During the two years of post procedurePopulation: Subjects who completed two years follow up
At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Outcome measures
| Measure |
NAVISTAR® THERMOCOOL® Catheter
n=92 Participants
Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
Antiarrhythmic Drug
n=35 Participants
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
|
Antiarrhythmic Drug
n=15 Participants
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
|
|---|---|---|---|
|
Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.
|
29.3 Percentage of Participants
|
28.6 Percentage of Participants
|
53.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: During the two years of post procedurePopulation: Subjects who completed the two-year health survey.
At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Outcome measures
| Measure |
NAVISTAR® THERMOCOOL® Catheter
n=92 Participants
Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
Antiarrhythmic Drug
n=35 Participants
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
|
Antiarrhythmic Drug
n=15 Participants
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
|
|---|---|---|---|
|
Percentage of Subjects Responded to Each of the Four Health Status Categories.
Two-Year Health Status: Improved
|
65.2 Percentage of Participants
|
60.0 Percentage of Participants
|
53.3 Percentage of Participants
|
|
Percentage of Subjects Responded to Each of the Four Health Status Categories.
Two-Year Health Status: Unchanged
|
29.3 Percentage of Participants
|
37.1 Percentage of Participants
|
33.3 Percentage of Participants
|
|
Percentage of Subjects Responded to Each of the Four Health Status Categories.
Two-Year Health Status: Worsened
|
5.4 Percentage of Participants
|
2.9 Percentage of Participants
|
6.7 Percentage of Participants
|
|
Percentage of Subjects Responded to Each of the Four Health Status Categories.
Two-Year Health Status: Missing
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
6.7 Percentage of Participants
|
Adverse Events
NAVISTAR® THERMOCOOL® Catheter
Serious events: 25 serious events
Other events: 23 other events
Deaths: 0 deaths
Antiarrhythmic Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NAVISTAR® THERMOCOOL® Catheter
n=139 participants at risk
Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization; OR received the Catheter after failing the effectiveness endpoint. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
Antiarrhythmic Drug
n=25 participants at risk
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame AND didn't undergo a study ablation procedure.
|
|---|---|---|
|
General disorders
Death
|
1.4%
2/139 • Number of events 2
|
0.00%
0/25
|
|
Cardiac disorders
Pericarditis
|
0.72%
1/139 • Number of events 1
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Pericardial Effusion
|
0.72%
1/139 • Number of events 1
|
0.00%
0/25
|
|
Vascular disorders
Vascular Access Complication
|
3.6%
5/139 • Number of events 5
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.72%
1/139 • Number of events 1
|
0.00%
0/25
|
|
Investigations
Hospitalization
|
5.0%
7/139 • Number of events 7
|
0.00%
0/25
|
|
Surgical and medical procedures
Tearing of atrial septum
|
0.72%
1/139 • Number of events 1
|
0.00%
0/25
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.72%
1/139 • Number of events 1
|
0.00%
0/25
|
|
Renal and urinary disorders
Hemoptysis/Right Kidney Stone
|
0.72%
1/139 • Number of events 1
|
0.00%
0/25
|
|
Renal and urinary disorders
Neoplasm/Kidney Nodule
|
1.4%
2/139 • Number of events 2
|
0.00%
0/25
|
|
Cardiac disorders
Emergency Department Visit
|
1.4%
2/139 • Number of events 2
|
0.00%
0/25
|
|
Renal and urinary disorders
Hematuria
|
0.72%
1/139 • Number of events 1
|
0.00%
0/25
|
Other adverse events
| Measure |
NAVISTAR® THERMOCOOL® Catheter
n=139 participants at risk
Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization; OR received the Catheter after failing the effectiveness endpoint. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
|
Antiarrhythmic Drug
n=25 participants at risk
The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame AND didn't undergo a study ablation procedure.
|
|---|---|---|
|
General disorders
Chest Pain
|
1.4%
2/139 • Number of events 2
|
0.00%
0/25
|
|
General disorders
Back pain
|
2.2%
3/139 • Number of events 3
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Hematoma
|
1.4%
2/139 • Number of events 2
|
0.00%
0/25
|
|
Renal and urinary disorders
Hematuria
|
2.2%
3/139 • Number of events 3
|
0.00%
0/25
|
|
Gastrointestinal disorders
Nausea, Vomiting/Rigors
|
1.4%
2/139 • Number of events 6
|
0.00%
0/25
|
|
Nervous system disorders
Neurologic Side Effects
|
2.2%
3/139 • Number of events 3
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Pericardial Effusion
|
1.4%
2/139 • Number of events 2
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Hematoma/Bleeding/groin pain
|
2.2%
3/139 • Number of events 5
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
2.2%
3/139 • Number of events 3
|
0.00%
0/25
|
Additional Information
Melissa Schultz, Project Manager, Regulatory Affairs
Biosense Webster
Phone: 800-729-9010
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is allowed to publish but must submit draft publication(s) to Biosense Webster, Inc. at least 30 days prior to submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER