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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02878213
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
EP Dynamics Research Ltd

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 Phase
Atrial Fibrillation Device: D700 System Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
Actual Study Start Date : September 23, 2016
Actual Primary Completion Date : January 25, 2017
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine


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




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



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, Older Adult)
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.

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


Locations
Russian Federation
Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
EP Dynamics Research Ltd
Investigators
Principal Investigator: Evgeny A Pokushalov, MD, PhD State Research Institute of Circulation Pathology

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: May 11, 2018
Last Verified: May 2018
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