The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Percutaneous catheter ablation of the cavotricuspid isthmus
AZ Cardiovascular Research Center
Phoenix, Arizona, United States
Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs)
Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)
Time frame: 7 days
Subjects Achieving Acute Procedural Success
Acute procedural success is defined as the demonstration of bidirectional cavotricuspid isthmus block at least 20 minutes following the last radiofrequency application at the cavotricuspid isthmus with the investigational System.
Time frame: 20 minutes post ablation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Arrhythmia Research Group
Jonesboro, Arkansas, United States
John Muir Health
Concord, California, United States
San Diego Cardiac Center Medical Group, Inc.
San Diego, California, United States
Hartford Hospital
Hartford, Connecticut, United States
BayCare Heath
Clearwater, Florida, United States
Celebration Hospital
Orlando, Florida, United States
Bayfront Health
St. Petersburg, Florida, United States
St Alphonsus Health System
Boise, Idaho, United States
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
...and 14 more locations