Trial Outcomes & Findings for NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study (NCT NCT00721149)

Last Updated: 2025-02-04

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

10 participants

Primary outcome timeframe

From study day 91 through day 361

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	NAVISTAR® THERMOCOOL® Catheter 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 Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	NAVISTAR® THERMOCOOL® Catheter 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 Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NAVISTAR® THERMOCOOL® Catheter n=10 Participants 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.
Age, Continuous	59.2 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
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	0 Participants n=5 Participants
Race (NIH/OMB) White	10 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	10 participants n=5 Participants
Hypertension Condition With Hypertension	3 Participants n=5 Participants
Hypertension Condition Without Hypertension	7 Participants n=5 Participants
Atrial Flutter Condition With Atrial Flutter	2 Participants n=5 Participants
Atrial Flutter Condition Without Atrial Flutter	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: From study day 91 through day 361

Population: The subjects who had a study ablation procedure.

Outcome measures

Outcome measures
Measure	NAVISTAR® THERMOCOOL® Catheter n=9 Participants 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.
Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.	66.7 Percentage of participants

PRIMARY outcome

Timeframe: within 7 days of ablation procedure

Population: The subjects who had a study 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

Outcome measures
Measure	NAVISTAR® THERMOCOOL® Catheter n=9 Participants 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.
The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 91 - 361

Population: The subjects who had a study ablation procedure.

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.

Outcome measures

Outcome measures
Measure	NAVISTAR® THERMOCOOL® Catheter n=9 Participants 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.
Percentage of Subjects Who Achieved Acute Success	100 Percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.

SF 36 Symptom Frequency and Severity Checklist

Outcome measures

Outcome data not reported

Adverse Events

NAVISTAR® THERMOCOOL® Catheter

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NAVISTAR® THERMOCOOL® Catheter n=9 participants at risk 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.
Blood and lymphatic system disorders Small hematoma - left groin	11.1% 1/9 • Number of events 1
Hepatobiliary disorders Gallstone, pancreatitis, cholelithiasis	11.1% 1/9 • Number of events 1

Additional Information

Diana Bordley, Director, Regulatory Affairs

Biosense Webster, Inc.

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