DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness

NCT02878213 | Completed Results

• 1 other identifier: CLN-D700-004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy

  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.

  30 days

• 1-month Patient Analysis

  ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy

  30 days

Study Arms (1)

D700 System

EXPERIMENTAL

Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).

Device: D700 System

Interventions

D700 System DEVICE

Atrial Fibrillation Ablation Procedure

D700 System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• EPD Solutions, A Philips Company: lead

Study Sites (1)

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

Novosibirsk, 630055, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chen Sagy Bross
• Organization: EPD Solutions

chensb@epd-medical.com

+972-50-5560073

Study Officials

• Evgeny A Pokushalov, MD, PhD

  State Research Institute of Circulation Pathology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 25, 2016
• Study Start: September 23, 2016
• Primary Completion: January 25, 2017
• Study Completion: November 16, 2017
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)