Status:
COMPLETED
A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
Lead Sponsor:
Abbott Medical Devices
Conditions:
Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac abl...
Detailed Description
This is a post market, prospective, multicenter, 2:1 randomized study of the EnligHTN™ Renal Denervation System in conjunction with atrial fibrillation ablation. Up to one hundred subjects with paroxy...
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years of age at time of consent
- Subject must be able and willing to provide written informed consent
- Subject must be able and willing to comply with the required follow-up schedule
- Subject is a candidate for catheter ablation for the treatment of paroxysmal or persistent atrial fibrillation as per the hospital standard of care
- Subject has office Systolic Blood Pressure ≥ 140 mmHg at baseline visit
- Subject has a daytime mean Systolic Ambulatory Blood Pressure \> 135 mmHg within 90 days prior to procedure
- Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is taking \>3 anti-hypertensive medications, including 1 diuretic
- Subject has been on a stable unchanged anti-hypertensive medication regimen for a minimum of 4 weeks prior to the ablation procedure
Exclusion
- Subject has long standing atrial fibrillation
- Subject has had a previous ablation for atrial fibrillation
- Subject has had a previous renal denervation procedure
- Subject has had a CABG procedure within the last 180 days (six months)
- Subject has a left atrial thrombus
- Subject has a contraindication to anticoagulation (i.e. heparin or warfarin)
- Subject has unstable angina
- Subject has had a myocardial infarction within the previous two months
- Subject has a left ventricular ejection fraction (LVEF) \<40% as determined by pre-procedure TTE
- Subject has significant renovascular abnormalities such as renal artery stenosis \> 30%
- Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
- Subject has hemodynamically significant valvular heart disease as determined by study investigator
- Subject has a life expectancy less than 12 months, as determined by the study investigator
- Subject is participating in another clinical study which has the potential to impact his/her hypertension or atrial fibrillation management (pharmaceutical/device/homeopathic)
- Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
- Subject has active systemic infection
- Subject has renal arteries \< 4 mm in diameter
- Subject has an estimated GFR \<45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
- Subject had a renal transplant or is awaiting a renal transplant
- Subject has blood clotting or bleeding abnormalities
- Subject has secondary arterial hypertension
Key Trial Info
Start Date :
April 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2018
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01907828
Start Date
April 15 2014
End Date
October 15 2018
Last Update
May 22 2020
Active Locations (2)
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1
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Germany, 01307
2
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289