Trial Outcomes & Findings for NAVISTAR® THERMOCOOL® SF Catheter: Observational Study (NCT NCT01585961)
NCT ID: NCT01585961
Last Updated: 2015-01-26
Results Overview
The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.
Recruitment status
COMPLETED
Target enrollment
511 participants
Primary outcome timeframe
Day 0 (procedure)
Results posted on
2015-01-26
Participant Flow
Participant milestones
| Measure |
Catheter Ablation
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Overall Study
STARTED
|
511
|
|
Overall Study
Safety
|
508
|
|
Overall Study
COMPLETED
|
478
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
Catheter Ablation
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Decision to use non-study catheter
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
23
|
|
Overall Study
Ablation cancelled for slow-heal wound
|
1
|
Baseline Characteristics
NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
Baseline characteristics by cohort
| Measure |
Catheter Ablation
n=511 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
265 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
246 Participants
n=5 Participants
|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
317 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
494 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
477 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
511 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (procedure)Population: Subset of Safety Population with non-missing endpoint data.
The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.
Outcome measures
| Measure |
Catheter Ablation
n=506 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Total Fluoroscopy Time
|
26.4 minutes
Standard Deviation 21.4
|
PRIMARY outcome
Timeframe: Day 0 (procedure)Population: Subset of Safety Population with non-missing endpoint data.
Outcome measures
| Measure |
Catheter Ablation
n=507 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Total Procedure Time
|
169.8 minutes
Standard Deviation 82.9
|
PRIMARY outcome
Timeframe: Day 0 (procedure)Population: Safety population
Confirmation of entrance and/or exit block across all targeted pulmonary veins.
Outcome measures
| Measure |
Catheter Ablation
n=508 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Acute Procedural Success
|
488 participants
|
SECONDARY outcome
Timeframe: Day 0 (procedure)Population: Subset of Safety Population with non-missing endpoint data.
RF applications is defined as the number of times RF energy is delivered during the procedure.
Outcome measures
| Measure |
Catheter Ablation
n=489 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Mean Number of Radiofrequency (RF) Applications
|
45.0 number of applications
Standard Deviation 35.1
|
SECONDARY outcome
Timeframe: Day 0 (procedure)Population: Subset of Safety Population with non-missing endpoint data.
Total RF time is defined as the total time that RF energy is delivered during the procedure.
Outcome measures
| Measure |
Catheter Ablation
n=505 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Total Radiofrequency (RF) Time
|
57.9 minutes
Standard Deviation 37.0
|
SECONDARY outcome
Timeframe: Day 0 (procedure)Population: Subset of Safety Population with non-missing endpoint data.
Outcome measures
| Measure |
Catheter Ablation
n=495 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Fluid Volume Delivered Via Ablation Catheter
|
974.2 mL
Standard Deviation 481.8
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Safety Population
Outcome measures
| Measure |
Catheter Ablation
n=508 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Number of Patients With Repeat Ablations
|
74 participants
|
SECONDARY outcome
Timeframe: 12 Month VisitPopulation: Subset of Safety Population with non-missing endpoint data.
Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit
Outcome measures
| Measure |
Catheter Ablation
n=470 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Post-procedure AF Symptoms
|
155 participants
|
SECONDARY outcome
Timeframe: 12 Month VisitPopulation: Subset of Safety Population with non-missing endpoint data.
Outcome measures
| Measure |
Catheter Ablation
n=477 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit
|
20 participants
|
SECONDARY outcome
Timeframe: 12 Month VisitPopulation: Population with Utilization Data
Outcome measures
| Measure |
Catheter Ablation
n=489 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation
|
73 participants
|
SECONDARY outcome
Timeframe: 12 Month VisitPopulation: Population with Utilization Data
Outcome measures
| Measure |
Catheter Ablation
n=489 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation
|
56 participants
|
SECONDARY outcome
Timeframe: Screening to 12 Month VisitPopulation: Subset of Safety Population with non-missing AFEQT data at 12 months.
Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.
Outcome measures
| Measure |
Catheter Ablation
n=462 Participants
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
|
36.0 units on a scale
Standard Deviation 23.7
|
Adverse Events
Catheter Ablation
Serious events: 63 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Catheter Ablation
n=508 participants at risk
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
9/508 • Number of events 9 • Procedure through 7 days post-procedure
|
|
Cardiac disorders
Cardiac tamponade
|
0.79%
4/508 • Number of events 4 • Procedure through 7 days post-procedure
|
|
Cardiac disorders
Pericardial effusion
|
0.79%
4/508 • Number of events 4 • Procedure through 7 days post-procedure
|
|
Cardiac disorders
Pericarditis
|
0.39%
2/508 • Number of events 2 • Procedure through 7 days post-procedure
|
|
Cardiac disorders
Cardiac failure congestive
|
0.59%
3/508 • Number of events 3 • Procedure through 7 days post-procedure
|
|
Cardiac disorders
Atrial tachycardia
|
0.39%
2/508 • Number of events 2 • Procedure through 7 days post-procedure
|
|
Cardiac disorders
Atrial flutter
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Cardiac disorders
Cardiac perforation
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Cardiac disorders
Sick sinus syndrome
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.39%
2/508 • Number of events 2 • Procedure through 7 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Blood and lymphatic system disorders
Anemia
|
0.59%
3/508 • Number of events 3 • Procedure through 7 days post-procedure
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
General disorders
Catheter site hematoma
|
0.59%
3/508 • Number of events 3 • Procedure through 7 days post-procedure
|
|
General disorders
Device difficult to use (foley)
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
General disorders
Non-cardiac chest pain
|
0.39%
2/508 • Number of events 2 • Procedure through 7 days post-procedure
|
|
General disorders
Pyrexia
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Infections and infestations
Pneumonia
|
0.59%
3/508 • Number of events 3 • Procedure through 7 days post-procedure
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.39%
2/508 • Number of events 2 • Procedure through 7 days post-procedure
|
|
Investigations
International normalized ratio decreased
|
0.59%
3/508 • Number of events 3 • Procedure through 7 days post-procedure
|
|
Investigations
Electrocardiogram ST segment depression
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Investigations
Hematocrit decreased
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Investigations
Hemoglobin decreased
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.59%
3/508 • Number of events 3 • Procedure through 7 days post-procedure
|
|
Nervous system disorders
Syncope
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Nervous system disorders
Transient global amnesia
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Renal and urinary disorders
Hematuria
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Renal and urinary disorders
Proteinuria
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Renal and urinary disorders
Renal failure acute
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Renal and urinary disorders
Urinary retention
|
0.39%
2/508 • Number of events 2 • Procedure through 7 days post-procedure
|
|
Vascular disorders
Femoral artery aneurysm
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
|
Vascular disorders
Hypotension
|
0.39%
2/508 • Number of events 2 • Procedure through 7 days post-procedure
|
|
Vascular disorders
Intra-abdominal hematoma
|
0.20%
1/508 • Number of events 1 • Procedure through 7 days post-procedure
|
Other adverse events
| Measure |
Catheter Ablation
n=508 participants at risk
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.0%
15/508 • Number of events 15 • Procedure through 7 days post-procedure
|
|
Cardiac disorders
Pericarditis
|
1.8%
9/508 • Number of events 9 • Procedure through 7 days post-procedure
|
|
Gastrointestinal disorders
Nausea
|
1.6%
8/508 • Number of events 8 • Procedure through 7 days post-procedure
|
|
General disorders
Pyrexia
|
1.2%
6/508 • Number of events 6 • Procedure through 7 days post-procedure
|
|
Injury, poisoning and procedural complications
Catheter site hematoma
|
2.2%
11/508 • Number of events 11 • Procedure through 7 days post-procedure
|
|
Injury, poisoning and procedural complications
Catheter site hemorrhage
|
3.3%
17/508 • Number of events 17 • Procedure through 7 days post-procedure
|
|
Metabolism and nutrition disorders
Fluid Overload
|
1.4%
7/508 • Number of events 7 • Procedure through 7 days post-procedure
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
11/508 • Number of events 11 • Procedure through 7 days post-procedure
|
|
Nervous system disorders
Dizziness
|
1.4%
7/508 • Number of events 7 • Procedure through 7 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
7/508 • Number of events 7 • Procedure through 7 days post-procedure
|
|
Vascular disorders
Hypotension
|
1.2%
6/508 • Number of events 6 • Procedure through 7 days post-procedure
|
Additional Information
Ellen Harris, Project Manager, Clinical Operations
Biosense Webster
Phone: 909-839-7376
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 for additional information.
- Publication restrictions are in place
Restriction type: OTHER