Trials / Terminated
TerminatedNCT02275260
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study (REDUCE-TE Pilot)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cerebral Diffusion-Weighted Magnetic Resonance Imaging | Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) |
| DEVICE | Transesophageal Echocardiography | Patients undergo a Transesophageal Echocardiography prior to the ablation itself |
| OTHER | Paperbased neurocognitive testing | To assess the impact of PVI on the patient's neurocognitive status |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2017-02-08
- Completion
- 2018-02-15
- First posted
- 2014-10-27
- Last updated
- 2019-11-01
Locations
14 sites across 5 countries: Czechia, Germany, Hungary, Netherlands, Switzerland
Source: ClinicalTrials.gov record NCT02275260. Inclusion in this directory is not an endorsement.