Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study (AFTX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00721149
Recruitment Status : Terminated (Enrollment stopped after CDRH Advisory Panel (Nov 20, 2008) recommended NAVISTAR® THERMOCOOL® catheter approval.)
First Posted : July 23, 2008
Results First Posted : January 22, 2014
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Heart Diseases
Arrhythmia
Atrial Fibrillation
Intervention Device: Radiofrequency Ablation
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NAVISTAR® THERMOCOOL® Catheter
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 10 [1]
Completed 9
Not Completed 1
Reason Not Completed
Physician Decision             1
[1]
Enrollment was stopped after 10 subjects entered the trial.
Arm/Group Title NAVISTAR® THERMOCOOL® Catheter
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
59.2  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Hypertension Condition  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
With Hypertension 3
Without Hypertension 7
Atrial Flutter Condition  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
With Atrial Flutter 2
Without Atrial Flutter 8
1.Primary Outcome
Title Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.
Hide Description A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).
Time Frame From study day 91 through day 361
Hide Outcome Measure Data
Hide Analysis Population Description
The subjects who had a study ablation procedure.
Arm/Group Title NAVISTAR® THERMOCOOL® Catheter
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
66.7
2.Primary Outcome
Title The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.
Hide Description 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.
Time Frame within 7 days of ablation procedure
Hide Outcome Measure Data
Hide Analysis Population Description
The subjects who had a study ablation procedure.
Arm/Group Title NAVISTAR® THERMOCOOL® Catheter
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
0.0
3.Secondary Outcome
Title Percentage of Subjects Who Achieved Acute Success
Hide Description Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.
Time Frame Day 91 - 361
Hide Outcome Measure Data
Hide Analysis Population Description
The subjects who had a study ablation procedure.
Arm/Group Title NAVISTAR® THERMOCOOL® Catheter
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Percentage of participants
100
4.Secondary Outcome
Title 24-hour Holter Data
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.
Arm/Group Title NAVISTAR® THERMOCOOL® Catheter
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title TTM Data
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.
Arm/Group Title NAVISTAR® THERMOCOOL® Catheter
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percentage of Subjects Who Responded to Quality of Life Assessment
Hide Description SF 36 Symptom Frequency and Severity Checklist
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.
Arm/Group Title NAVISTAR® THERMOCOOL® Catheter
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NAVISTAR® THERMOCOOL® Catheter
Hide Arm/Group Description 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.
All-Cause Mortality
NAVISTAR® THERMOCOOL® Catheter
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NAVISTAR® THERMOCOOL® Catheter
Affected / at Risk (%) # Events
Total   0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
NAVISTAR® THERMOCOOL® Catheter
Affected / at Risk (%) # Events
Total   2/9 (22.22%)    
Blood and lymphatic system disorders   
Small hematoma - left groin   1/9 (11.11%)  1
Hepatobiliary disorders   
Gallstone, pancreatitis, cholelithiasis   1/9 (11.11%)  1
Indicates events were collected by systematic assessment
Because of early study termination, the study did not reach its targeted enrollment and study data analysis was not fully conducted, thus study results may not be interpretable.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Diana Bordley, Director, Regulatory Affairs
Organization: Biosense Webster, Inc.
Phone: 800-729-9010 ext 8604
EMail: dbordley@its.jnj.com
Layout table for additonal information
Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00721149     History of Changes
Other Study ID Numbers: BWI03130TXA
First Submitted: July 21, 2008
First Posted: July 23, 2008
Results First Submitted: February 8, 2013
Results First Posted: January 22, 2014
Last Update Posted: January 22, 2014