Trials / Completed
CompletedNCT01520532
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
Evaluate Reduction in Asymptomatic Cerebral Embolism
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Magnetic Resonance Imaging (MRI) | MRI's will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at the Pre-Discharge will undergo an MRI at the 1 month follow-up visit. |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2012-01-30
- Last updated
- 2018-10-16
- Results posted
- 2013-03-14
Locations
7 sites across 5 countries: Belgium, Canada, Germany, Italy, Netherlands
Source: ClinicalTrials.gov record NCT01520532. Inclusion in this directory is not an endorsement.