# Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)

> **NCT01116557** · PHASE4 · TERMINATED · sponsor: **Biosense Webster, Inc.** · enrollment: 79 (actual)

## Conditions studied

- Atrial Fibrillation

## Interventions

- **DEVICE:** Radiofrequency Ablation procedure
- **DEVICE:** Radiofrequency Ablation procedure

## Key facts

- **NCT ID:** NCT01116557
- **Lead sponsor:** Biosense Webster, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2010-04
- **Primary completion:** 2011-12
- **Final completion:** 2011-12
- **Target enrollment:** 79 (ACTUAL)
- **Why stopped:** Biosense stopped Study enrollment following publications that reported PVAC ablation is linked with a higher incidence of asymptomatic cerebral embolic lesions
- **Last updated:** 2025-02-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01116557

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01116557, "Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01116557. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*