Atrial Fibrillation Clinical Trial
— DURABLE-IOfficial title:
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
Verified date | May 2018 |
Source | EP Dynamics Research Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | November 16, 2017 |
Est. primary completion date | January 25, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology | Novosibirsk |
Lead Sponsor | Collaborator |
---|---|
EP Dynamics Research Ltd |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 1-month Patient Analysis | ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy | 30 days |
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