Trials / Completed
CompletedNCT03723070
Cryoablation System FIM/CE Mark Study
Cryterion Cardiac Cryoablation System CE Mark Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System
Detailed description
This is a single-arm, open-label clinical study using a cryoablation balloon device to isolate pulmonary veins during an atrial fibrillation ablation procedure. Cryo is a scientifically proven energy source used to create a thermal injury during endocardial ablation. The investigational device uses current technology with minor design modifications and will be studied to validate similarities in the safety and performance parameters compared to literature.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | The Cryterion Cardiac Cryoablation System | Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins |
Timeline
- Start date
- 2018-05-15
- Primary completion
- 2020-12-22
- Completion
- 2020-12-22
- First posted
- 2018-10-29
- Last updated
- 2025-04-04
- Results posted
- 2021-07-19
Locations
4 sites across 3 countries: Croatia, Netherlands, New Zealand
Source: ClinicalTrials.gov record NCT03723070. Inclusion in this directory is not an endorsement.