AcQBlate Force Confirmatory Study for Atrial Arrhythmias
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04429464|
Recruitment Status : Withdrawn (Due to restrictions related to COVID the sponsor has decided not to move forward with this study)
First Posted : June 12, 2020
Last Update Posted : October 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Atrial Arrhythmias||Device: AcQBlate Force Sensing Ablation Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo or repeat left-sided atrial ablation for symptomatic paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PerAF).|
|Masking:||None (Open Label)|
|Official Title:||AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||November 15, 2020|
|Estimated Study Completion Date :||November 15, 2020|
All subjects will be treated using the Acutus Medical's AcQBlate Force Sensing Ablation Catheter in combination with the Qubic Force Sensing Module (AcQBlate Force Sensing System) to treat their arrhythmia.
Device: AcQBlate Force Sensing Ablation Catheter
Confirmation that the AcQBlate Force System is safe and effective for the treatment of atrial arrhythmias
- Subjects that demonstrate electrical isolation of the intended ablation [ Time Frame: At the end of their ablation procedure ]The Primary Endpoint for Performance is an analysis of the proportion of subjects that demonstrate electrical isolation (block) of the intended ablation targets.
- Proportion of subjects who are free from device/procedure related Major Adverse Events [ Time Frame: Through 30-days post procedure ]The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 30-days.
- Subjects with freedom from an atrial arrhythmia [ Time Frame: 30-days post index procedure ]The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 30-days post index procedure.
- Analysis of all identified SAEs, SADEs, and UADEs. [ Time Frame: Through 30-days post procedure ]The Secondary Endpoint for Safety is a recording and analysis of all identified serious adverse events (SAEs), serious adverse device effects (SADEs), and unanticipated adverse device effects (UADEs) through 30-days post-procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429464
|Na Homolce Hospital|
|Prague, Czechia, 150 30|
|Principal Investigator:||Petr Neuzil, MD||Na Homolce Hospital|