Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-19 @ 2:19 AM
Study NCT ID:
NCT02275260
Status:
TERMINATED
Last Update Posted:
2019-11-01
First Post:
2014-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study
Sponsor:
Biotronik SE & Co. KG
Organization:
Study Overview
Official Title:
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study (REDUCE-TE Pilot)
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The required number of endpoints will be obtained with a sample size lower than initially planned.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: