Clinical trial NCT02878213: DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
Official title: DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: EPD Solutions, A Philips Company
Sponsor class: INDUSTRY
First posted: 2016-08-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
timeFrame: 30 days
measure: 1-month Patient Analysis
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny A Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: