Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT02768051
Status:
WITHDRAWN
Last Update Posted:
2018-05-17
First Post:
2016-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures
Sponsor:
EPD Solutions, A Philips Company
Organization:
Study Overview
Official Title:
EP Dynamics (EPD) Research First In Man Clinical Study
Status:
WITHDRAWN
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision of the management
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter.
Prospective, single-center, non-randomized, open label, single arm study. Ten consented subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation procedure) and post procedure follow up. All subjects will have a follow up visit within 24 hours post procedure.
Prospective, single-center, non-randomized, open label, single arm study. Ten consented subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation procedure) and post procedure follow up. All subjects will have a follow up visit within 24 hours post procedure.
Detailed Description:
All procedures will be performed under standard fluoroscopic guidance for the treatment of atrial flutter ablation procedure, and the D700 system will be used additionally to demonstrate system safety, feasibility and usability.
The entire procedure will be conducted as customary, using standard and approved off- the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF generator and recording system), in a completely clinically independent manner from the D700 system that will merely be a 'silent witness'. The operator will neither use nor rely on any of the D700 system output for clinical decision making.
The entire procedure will be conducted as customary, using standard and approved off- the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF generator and recording system), in a completely clinically independent manner from the D700 system that will merely be a 'silent witness'. The operator will neither use nor rely on any of the D700 system output for clinical decision making.
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?: