DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness

NCT ID: NCT02878213

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-23
• Study Completion Date: 2017-11-16

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

D700 System

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

Group Type: EXPERIMENTAL

D700 System

Intervention Type: DEVICE

Atrial Fibrillation Ablation Procedure

Interventions

D700 System

Atrial Fibrillation Ablation Procedure

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EPD Solutions, A Philips Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evgeny A Pokushalov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

State Research Institute of Circulation Pathology

Locations

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

Novosibirsk, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLN-D700-004

Identifier Type: -

Identifier Source: org_study_id