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AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU) — AFL-EU  

Typical Atrial Flutter Clinical Trial

Official title:
AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter (AcQForce Flutter-EU)

Clinical Trial Summary

The Acutus Medical AcQForce Flutter-EU clinical study is a prospective, multi-center, non-randomized global study designed to confirm the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter. The AcQForce Flutter-EU study is a post-market study that will be run in parallel with a US IDE study of similar design. Data will be combined to support a pre-market approval (PMA) application to the US Food and Drug Administration (FDA).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04657055
Study type Interventional
Source Acutus Medical
Contact Jerald Cox, PA
Phone 762-529-6310
Email jerry.cox@acutus.com
Status Recruiting
Phase N/A
Start date April 23, 2021
Completion date February 28, 2022
View Details
See also
  Status Clinical Trial Phase
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Completed NCT01401361 - Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System Phase 3
Completed NCT00984204 - Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL) Phase 3
Withdrawn NCT01710150 - Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter N/A
Completed NCT01408485 - Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter N/A
Completed NCT04658940 - AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter) N/A
Recruiting NCT00750711 - Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters N/A
Recruiting NCT03867266 - Typical Atrial Flutter, Ablation Index and Point by Point Ablation
Not yet recruiting NCT06157437 - An Exploratory Study of Focal Pulse Ablation System in the Treatment of Typical Atrial Flutter N/A