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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Renal artery denervation using the EnligHTN™ Renal Denervation System
Safire BLU™ Duo or Therapy Cool Path Duo Irrigated Ablation Catheter or Therapy Cool Flex Irrigated Ablation Catheter EnSite Velocity System Agilis NxT Guiding Introducer
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Number of Participants With Freedom From Atrial Fibrillation at 12 Month
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).
Time frame: 12 months
Major Adverse Cardiac Events (MACE)
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).
Time frame: 7 days, 6 months, 12 months, and 24 months post procedure
Percentage of Participants Who Experience Peri-procedural Events
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)
Time frame: 30 days post procedure
Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation
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).
Time frame: 6 months and 12 months post procedure
Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months
Time frame: Baseline and 6 months
Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months
Time frame: Baseline and 12 months
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Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.
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)
Time frame: 3 months, 6 months, 12 months, 24 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg
Time frame: 6 months post procedure
Change in Ambulatory Blood Pressure at 12 Months
Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14)
Time frame: Baseline and 12 months post procedure
Change in Ambulatory Blood Pressure at 24 Months
Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12)
Time frame: Baseline and 24 months post procedure
Change in Office Blood Pressure at 12 Months
Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15)
Time frame: Baseline and 12 months post procedure
Change in Office Blood Pressure at 24 Months
Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16).
Time frame: Baseline and 24 months post procedure