Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures
Primary Purpose
Atrial Flutter
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AF Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter
Eligibility Criteria
Inclusion Criteria:
- Subject is at least 18 years of age.
- Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures.
- Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
- Subject is generally in good health.
- A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
- Subject is deemed amenable to therapeutic ablation for atrial flutter.
Exclusion Criteria:
- Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
- Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
- Patient had experienced previous stroke (TIA or CVA).
- Patient has a pacemaker.
- Thrombi detected in the heart.
- Known marked valvar insufficiency.
- Life expectancy less than 12 months.
- Known severe renal insufficiency.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AF Ablation Intervention
Arm Description
Subjects who are scheduled to undergo ablation procedure due to atrial flutter.
Outcomes
Primary Outcome Measures
Safety Endpoint - Any intra-procedural or immediate post-procedure complications.
Secondary Outcome Measures
Feasibility - Freedom from any impact on current workflow or clinical efficacy.
Usability - Correct visualization of the catheter spatial location (map reference).
Full Information
NCT ID
NCT02768051
First Posted
May 1, 2016
Last Updated
May 14, 2018
Sponsor
EPD Solutions, A Philips Company
1. Study Identification
Unique Protocol Identification Number
NCT02768051
Brief Title
Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures
Official Title
EP Dynamics (EPD) Research First In Man Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision of the management
Study Start Date
May 2016 (Anticipated)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EPD Solutions, A Philips Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AF Ablation Intervention
Arm Type
Experimental
Arm Description
Subjects who are scheduled to undergo ablation procedure due to atrial flutter.
Intervention Type
Procedure
Intervention Name(s)
AF Ablation
Primary Outcome Measure Information:
Title
Safety Endpoint - Any intra-procedural or immediate post-procedure complications.
Time Frame
Intra-procedural or immediate post-procedure
Secondary Outcome Measure Information:
Title
Feasibility - Freedom from any impact on current workflow or clinical efficacy.
Time Frame
Intra-procedural or immediate post-procedure
Title
Usability - Correct visualization of the catheter spatial location (map reference).
Time Frame
Intra-procedural or immediate post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is at least 18 years of age.
Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures.
Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
Subject is generally in good health.
A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
Subject is deemed amenable to therapeutic ablation for atrial flutter.
Exclusion Criteria:
Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
Patient had experienced previous stroke (TIA or CVA).
Patient has a pacemaker.
Thrombi detected in the heart.
Known marked valvar insufficiency.
Life expectancy less than 12 months.
Known severe renal insufficiency.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures
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