Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation
NCT02839304 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2021-09-20
Summary
The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.
Conditions
- Atrial Fibrillation
- Atrial Flutter
Interventions
- DEVICE
-
Cryoablation System
Pulmonary Vein Isolation, Posterior Wall Isolation. May Include Mitral Line ablation, AF Driver ablation, and Cavo-tricuspid Isthmus ablation as indicated
Sponsors & Collaborators
-
Adagio Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2020-03-31
- Completion
- 2021-03-31
Countries
- Belgium
- France
- Netherlands
Study Locations
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