18 and older, any sex, with Heart Diseases or Arrhythmia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)Primary· The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.
Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.
Group
Value
95% CI
NAVISTAR® THERMOCOOL® Catheter
66
Antiarrhythmic Drug
16
The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse EventsPrimary· Within 7 Days of Ablation Procedure
The Percentage of Subjects Who Achieved Acute Success.Secondary· 90 days post study procedure
Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.
Group
Value
95% CI
NAVISTAR® THERMOCOOL® Catheter
100
Antiarrhythmic Drug
94
Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.Secondary· During the two years of post procedure
At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Group
Value
95% CI
NAVISTAR® THERMOCOOL® Catheter
29.3
Antiarrhythmic Drug Subjects Undergoing Ablation
28.6
Antiarrhythmic Drug
53.3
Percentage of Subjects Responded to Each of the Four Health Status Categories.Secondary· During the two years of post procedure
At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Two-Year Health Status: Improved
Group
Value
95% CI
NAVISTAR® THERMOCOOL® Catheter
65.2
Antiarrhythmic Drug Subjects Undergoing Ablation
60.0
Antiarrhythmic Drug
53.3
Two-Year Health Status: Unchanged
Group
Value
95% CI
NAVISTAR® THERMOCOOL® Catheter
29.3
Antiarrhythmic Drug Subjects Undergoing Ablation
37.1
Antiarrhythmic Drug
33.3
Two-Year Health Status: Worsened
Group
Value
95% CI
NAVISTAR® THERMOCOOL® Catheter
5.4
Antiarrhythmic Drug Subjects Undergoing Ablation
2.9
Antiarrhythmic Drug
6.7
Two-Year Health Status: Missing
Group
Value
95% CI
NAVISTAR® THERMOCOOL® Catheter
0.0
Antiarrhythmic Drug Subjects Undergoing Ablation
0.0
Antiarrhythmic Drug
6.7
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07288216 — Transition to KPL-387 Monotherapy Dosing & Administration Study
· Phase 2
· recruiting
NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO
· NA
· recruiting
NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under
· NA
· recruiting
NCT06954610 — Cardiac Assessment for Recurrent Stroke Risk Evaluation in Atrial Fibrillation
· recruiting
NCT06769880 — Use of Bedside Imaging and Community Health Workers for Early Screening and Referral of Pre-symptomatic Stage B Heart Fa
· NA
· recruiting
Other Biosense Webster, Inc. trials
Trials by the same sponsor.
NCT07527299 — A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior
· NA
· not yet recruiting
NCT07523750 — A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants Wit
· NA
· not yet recruiting
NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
· NA
· recruiting
NCT07428564 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF
· NA
· not yet recruiting
NCT07227532 — A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Cathe
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biosense Webster, Inc.
Last refreshed: 24 October 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00116428.