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

• ClinicalTrials.gov Identifier: NCT02878213
• Recruitment Status: Completed
• First Posted: August 25, 2016
• Results First Posted: November 18, 2019
• Last Update Posted: November 18, 2019
• Sponsor: EPD Solutions, A Philips Company
• Information provided by (Responsible Party): EPD Solutions, A Philips Company

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	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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: N/A
• 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: November 16, 2017

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. ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy [ Time Frame: 30 days ]

   ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy. All patients underwent PVI at index procedure. The physicians were blinded to the D700 (KODEX-EPD) ETA function pairwise real-time lesion assessment readings.

   All patients were restudied at 1-mont, and ETA reading, which is the number of gaps as predicted by the system, were compared to the actual gaps as validated in the second procedure after one month.

2. 1-month Patient Analysis [ Time Frame: 30 days ]
   ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Russian Federation

Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology

Novosibirsk, Russian Federation, 630055

Sponsors and Collaborators

EPD Solutions, A Philips Company

Investigators

• Principal Investigator: Evgeny A Pokushalov, MD, PhD; State Research Institute of Circulation Pathology

  Study Documents (Full-Text)

Documents provided by EPD Solutions, A Philips Company:

Study Protocol and Statistical Analysis Plan  [PDF] September 18, 2016

More Information

• Responsible Party: EPD Solutions, A Philips Company
• ClinicalTrials.gov Identifier: NCT02878213
• Other Study ID Numbers: CLN-D700-004
• First Posted: August 25, 2016
• Results First Posted: November 18, 2019
• Last Update Posted: November 18, 2019
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes