NCT02131337

TactiCath® Prospective Effectiveness Pilot Study

Efficacy Study on Atrial Fibrillation Percutaneous Catheter Ablation With Contact Force Support 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

EFFICAS II proposes to test the hypothesis that treatment efficacy correlates to contact force parameters applied for pulmonary vein isolation (PVI) during AF ablation.

Detailed description

EFFICAS II is a single-arm, prospective study, where the operator will have access to contact force information and use it actively to optimize the ablation result and adapting power if necessary. The endpoint will correlate contact force parameters initially applied in PV and 3 months PV isolation status, and compare results to those of EFFICAS I.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	Electrophysiology study	after 3 months to check for pulmonary vein isolation (PVI) status

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2014-05-06
• Last updated: 2019-01-30

Locations

3 sites across 2 countries: Czechia, Germany