Trials / Completed
CompletedNCT04658940
AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Acutus Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AcQBlate® Force Sensing Ablation System | Percutaneous catheter ablation of the cavotricuspid isthmus |
Timeline
- Start date
- 2021-03-25
- Primary completion
- 2022-05-12
- Completion
- 2022-06-12
- First posted
- 2020-12-09
- Last updated
- 2023-09-28
- Results posted
- 2023-09-28
Locations
24 sites across 3 countries: United States, Belgium, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04658940. Inclusion in this directory is not an endorsement.