Clinical trial NCT01907828: A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
Official title: A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Hypertension
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-07-25
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ablation will result in improved outcomes as compared to ablation alone in patients with uncontrolled hypertension being treated for Atrial Fibrillation

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 paroxysmal or persistent atrial fibrillation and uncontrolled hypertension will be enrolled in the study. All subjects will undergo cardiac ablation for the treatment of atrial fibrillation. Per the 2:1 randomization, a minimum of 50 or 2/3 of the total patient cohort will also undergo renal artery ablation. Subjects will be followed up to years (2) years post procedure.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Freedom From Atrial Fibrillation at 12 Month
timeFrame: 12 months
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 7 days, 6 months, 12 months, and 24 months post procedure
measure: Percentage of Participants Who Experience Peri-procedural Events
timeFrame: 30 days post procedure
measure: Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation
timeFrame: 6 months and 12 months post procedure
measure: Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months
timeFrame: Baseline and 6 months
measure: Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months
timeFrame: Baseline and 12 months
measure: Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.
timeFrame: 3 months, 6 months, 12 months, 24 months
measure: Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg
timeFrame: 6 months post procedure
measure: Change in Ambulatory Blood Pressure at 12 Months
timeFrame: Baseline and 12 months post procedure
measure: Change in Ambulatory Blood Pressure at 24 Months
timeFrame: Baseline and 24 months post procedure
measure: Change in Office Blood Pressure at 12 Months
timeFrame: Baseline and 12 months post procedure
measure: Change in Office Blood Pressure at 24 Months
timeFrame: Baseline and 24 months post procedure
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
Study officials:
affiliation: Herzzentrum Dresden GmbH Universitätsklinik
name: Christopher Piorkowski, MD
role: PRINCIPAL_INVESTIGATOR
References: