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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by EP Dynamics Research Ltd
Sponsor:
Information provided by (Responsible Party):
EP Dynamics Research Ltd
ClinicalTrials.gov Identifier:
NCT02878213
First received: July 28, 2016
Last updated: November 22, 2016
Last verified: September 2016
  Purpose
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 Intervention
Atrial Fibrillation
Device: D700 System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness

Resource links provided by NLM:


Further study details as provided by EP Dynamics Research Ltd:

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


Estimated Enrollment: 24
Study Start Date: September 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Russia, 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
Study First Received: July 28, 2016
Last Updated: November 22, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

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

ClinicalTrials.gov processed this record on May 25, 2017