Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures

May 14, 2018 updated by: EPD Solutions, A Philips Company

EP Dynamics (EPD) Research First In Man Clinical Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is at least 18 years of age.
  2. Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures.
  3. Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
  4. Subject is generally in good health.
  5. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
  6. Subject is deemed amenable to therapeutic ablation for atrial flutter.

Exclusion Criteria:

  1. Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
  2. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
  3. Patient had experienced previous stroke (TIA or CVA).
  4. Patient has a pacemaker.
  5. Thrombi detected in the heart.
  6. Known marked valvar insufficiency.
  7. Life expectancy less than 12 months.
  8. Known severe renal insufficiency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AF Ablation Intervention
Subjects who are scheduled to undergo ablation procedure due to atrial flutter.
Procedure: AF Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Endpoint - Any intra-procedural or immediate post-procedure complications.
Time Frame: Intra-procedural or immediate post-procedure
Intra-procedural or immediate post-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Feasibility - Freedom from any impact on current workflow or clinical efficacy.
Time Frame: Intra-procedural or immediate post-procedure
Intra-procedural or immediate post-procedure
Usability - Correct visualization of the catheter spatial location (map reference).
Time Frame: Intra-procedural or immediate post-procedure
Intra-procedural or immediate post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EPD Solutions, A Philips Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 1, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-D700-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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