Back to results

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Withdrawn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

About this trial

This is an interventional treatment trial for Atrial Flutter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

We'll reach out to this number within 24 hrs