NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study (AFTX)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases Arrhythmia Atrial Fibrillation||Device: Radiofrequency Ablation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
|Experimental: NaviStar ThermoCool||
Device: Radiofrequency Ablation
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. [ Time Frame: From study day 91 through day 361 ]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).
- The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events. [ Time Frame: within 7 days of 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.
- Percentage of Subjects Who Achieved Acute Success [ Time Frame: Day 91 - 361 ]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.
- 24-hour Holter Data [ Time Frame: 1 year ]
- TTM Data [ Time Frame: 1 year ]
- Percentage of Subjects Who Responded to Quality of Life Assessment [ Time Frame: 1 year ]SF 36 Symptom Frequency and Severity Checklist
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721149
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||David Wilber, MD||Loyola University Medical Center Chicago|