A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence

Not Applicable

Completed

Conditions: Persistent Atrial Fibrillation
Hypertension
Paroxysmal Atrial Fibrillation

Interventions: Device: Cardiac Ablation
Device: Renal Artery Ablation

Registration Number: NCT01907828

Lead Sponsor: Abbott Medical Devices

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac ablation	Cardiac Ablation	Cardiac ablation
Cardiac ablation + renal artery ablation	Renal Artery Ablation	Renal artery ablation with the EnligHTN™ Renal Denervation System
Cardiac ablation + renal artery ablation	Cardiac Ablation	Renal artery ablation with the EnligHTN™ Renal Denervation System

Primary Outcome Measures

Name	Time	Method
Number of Participants With Freedom From Atrial Fibrillation at 12 Month	12 months	The freedom from atrial fibrillation was assessed based on electrocardiographic data during nine months following the blanking period including the one week recording coinciding with the 12 month follow-up visit (9 months following the 3 month blanking period).

Secondary Outcome Measures

Name	Time	Method
Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.	3 months, 6 months, 12 months, 24 months	Recurrence of AF was summarized as a percentage based on the number of subjects who underwent the procedure (RDN+AF group= 39, AF group=20)
Change in Ambulatory Blood Pressure at 12 Months	Baseline and 12 months post procedure	Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14)
Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months	Baseline and 6 months
Percentage of Participants Who Experience Peri-procedural Events	30 days post procedure	Peri-procedural events within 30 days post procedure were summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22)
Change in Office Blood Pressure at 12 Months	Baseline and 12 months post procedure	Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15)
Change in Office Blood Pressure at 24 Months	Baseline and 24 months post procedure	Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16).
Major Adverse Cardiac Events (MACE)	7 days, 6 months, 12 months, and 24 months post procedure	Major adverse cardiac events (MACE) were summarized as a percentage based on number of subjects at baseline for each group (RDN+AF group = 39, AF group = 22).
Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation	6 months and 12 months post procedure	Renovascular safety (new renal artery stenosis or aneurysm) was summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22).
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg	6 months post procedure
Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months	Baseline and 12 months
Change in Ambulatory Blood Pressure at 24 Months	Baseline and 24 months post procedure	Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12)