Trial Outcomes & Findings for CARTO® 3 System and Real Time Intracardiac Ultrasound (NCT NCT01716663)
NCT ID: NCT01716663
Last Updated: 2014-12-01
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.
Recruitment status
COMPLETED
Target enrollment
234 participants
Primary outcome timeframe
Day 0
Results posted on
2014-12-01
Participant Flow
Participant milestones
| Measure |
Experimental: Catheter Ablation
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
|
|---|---|
|
Overall Study
STARTED
|
234
|
|
Overall Study
Safety
|
230
|
|
Overall Study
COMPLETED
|
228
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Experimental: Catheter Ablation
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
|
|---|---|
|
Overall Study
Withdrawn prior to procedure
|
4
|
|
Overall Study
Treated with non-study catheter
|
2
|
Baseline Characteristics
CARTO® 3 System and Real Time Intracardiac Ultrasound
Baseline characteristics by cohort
| Measure |
Experimental: Catheter Ablation
n=234 Participants
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
114 Participants
n=5 Participants
|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
230 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
223 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Those patients with non-missing fluoroscopy time.
The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
Outcome measures
| Measure |
Experimental: Catheter Ablation
n=221 Participants
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
|
|---|---|
|
Total Fluoroscopy Time
|
28.3 minutes
Standard Deviation 29.71
|
SECONDARY outcome
Timeframe: Day 0Population: The number of patients with non-missing procedure time data.
The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
Outcome measures
| Measure |
Experimental: Catheter Ablation
n=225 Participants
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
|
|---|---|
|
Total Procedure Time
|
150.2 minutes
Standard Deviation 76.32
|
SECONDARY outcome
Timeframe: Day 0Population: Acute effectiveness and efficiency cohort
Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.
Outcome measures
| Measure |
Experimental: Catheter Ablation
n=228 Participants
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
|
|---|---|
|
Acute Procedural Success
|
226 participants
|
SECONDARY outcome
Timeframe: Day 0Population: Patients with non-missing RF application values
RF application is defined as the number of times RF energy is delivered during the procedure.
Outcome measures
| Measure |
Experimental: Catheter Ablation
n=227 Participants
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
|
|---|---|
|
Mean Number of Radiofrequency (RF) Applications
|
54.2 number of applications
Standard Deviation 43.95
|
SECONDARY outcome
Timeframe: Day 0Population: Patients with non-missing RF application time.
Total RF time is defined as the total time RF is delivered during the procedure.
Outcome measures
| Measure |
Experimental: Catheter Ablation
n=227 Participants
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
|
|---|---|
|
Total Radiofrequency (RF) Time
|
104.7 minutes
Standard Deviation 57.64
|
Adverse Events
Experimental: Catheter Ablation
Serious events: 22 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Catheter Ablation
n=230 participants at risk
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
|
|---|---|
|
Cardiac disorders
atrial fibrillation
|
0.43%
1/230 • 7 days
|
|
Cardiac disorders
atrial flutter
|
0.43%
1/230 • 7 days
|
|
Cardiac disorders
atrioventricular block
|
0.43%
1/230 • 7 days
|
|
Cardiac disorders
cardiac failure congestive
|
0.87%
2/230 • 7 days
|
|
Cardiac disorders
pericardial effusion/tamponade
|
1.3%
3/230 • 7 days
|
|
Cardiac disorders
pericarditis
|
1.3%
3/230 • 7 days
|
|
Ear and labyrinth disorders
vertigo positional
|
0.43%
1/230 • 7 days
|
|
General disorders
chest pain
|
0.43%
1/230 • 7 days
|
|
General disorders
puncture site hemorrhage
|
0.43%
1/230 • 7 days
|
|
Infections and infestations
pneumonia
|
0.43%
1/230 • 7 days
|
|
Injury, poisoning and procedural complications
post procedural hematoma
|
0.43%
1/230 • 7 days
|
|
Injury, poisoning and procedural complications
vascular pseudoaneurysm
|
0.87%
2/230 • 7 days
|
|
Investigations
cardiac telemetry abnormal
|
0.43%
1/230 • 7 days
|
|
Metabolism and nutrition disorders
fluid overload
|
0.43%
1/230 • 7 days
|
|
Nervous system disorders
migraine
|
0.43%
1/230 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm
|
0.43%
1/230 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.43%
1/230 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
0.43%
1/230 • 7 days
|
Other adverse events
| Measure |
Experimental: Catheter Ablation
n=230 participants at risk
These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
|
|---|---|
|
Cardiac disorders
atrial fibrillation
|
3.0%
7/230 • 7 days
|
|
Cardiac disorders
pericarditis
|
1.3%
3/230 • 7 days
|
|
General disorders
pyrexia
|
1.7%
4/230 • 7 days
|
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