N/A
Completed N=39
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
Source: ClinicalTrials.gov NCT02878213 ↗Enrolled (actual)
39
Serious AEs
2.6%
Results posted
Nov 2019
Primary outcomePrimary: ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy — 231; 1549; 48; 13 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy |
231; 1549; 48; 13 | — |
| PRIMARY 1-month Patient Analysis |
18; 9; 9; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02878213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.