We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness (DURABLE-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02878213
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric sensing compared with customary electrical isolation tests and Adenosine infusion at the end of the procedure. Furthermore, safety, usability and clinical applicability of the system for guided AF ablation will be confirmed.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: D700 System

Detailed Description:

Prospective, single-center, non-randomized, non-blinded, open label, and single arm study.

All procedures will be performed under CARTO-3 guidance for the treatment of atrial fibrillation (AF). The EPD D700 system will be used in-tandem, to record pre-, during and immediate post-ablation tissue characteristics and compute likelihood of lesion transmurality and permanency. Additionally, D700 system safety, feasibility, usability and clinical applicability will be documented.

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 EPD D700 system. The physician will neither use nor rely on any of the D700 system output for clinical decision making and will be blinded to the D700 lesion assessment forecasts. After 30 days following the initial procedure, a repeated procedure will be performed for gap detection and its results will be correlated with the D700 predictions.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: D700 System
Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).
Device: D700 System
Atrial Fibrillation Ablation Procedure


Outcome Measures

Primary Outcome Measures :
  1. Gap detection [ Time Frame: 30 days ]
    Evaluation of ablation gap detection using EPD D700 system.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients, age ≥ 18 and ≤ 80 years.
  2. Paroxysmal atrial fibrillation (PAF)
  3. Able to provide written informed consent form to participate in the study, prior to any study related procedures.
  4. Able and willing to comply with the study protocol requirements.
  5. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.

Exclusion Criteria:

  1. Any planned surgical or endovascular intervention within 30 days before or after the index procedures.
  2. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
  3. Previous AF ablation therapy.
  4. Clinical evidence of active coronary ischemia, significant Valvular heart disease, or hemodynamically significant congenital cardiac abnormality.
  5. Patient had experienced myocardial infarction (MI), stroke (CVA) or transient ischemic attack (TIA) or other neurological disturbances.
  6. Patient has a pacemaker.
  7. Thrombi detected in the heart.
  8. Life expectancy less than 12 months.
  9. Known severe renal insufficiency.
  10. Known allergy to Iodine.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878213


Contacts
Contact: Marina M Nikitenko +7-913-720-06-79 nikitenko.marina.maratovna@gmail.com
Contact: Andrei Bazarov, MD +7 495 956 1309 ext 308 abazarov@ameruss.com

Locations
Russian Federation
Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Alexander Romanov    +73833327655      
Sponsors and Collaborators
EP Dynamics Research Ltd
Investigators
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology
More Information

Responsible Party: EP Dynamics Research Ltd
ClinicalTrials.gov Identifier: NCT02878213     History of Changes
Other Study ID Numbers: CLN-D700-004
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes