Autopsy report · 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®)

“Biosense stopped Study enrollment following publications that reported PVAC ablation is linked with a higher incidence of asymptomatic cerebral embolic lesions”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 1 year 8 months before it stopped.
• 79 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

Biosense Webster, Inc.

Sponsor type

Industry

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation procedure; Radiofrequency Ablation procedure

Participants

79

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.