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

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Renal Artery Ablation; Device: Cardiac Ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Herzzentrum Dresden GmbH Universitätsklinik
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac ablation + renal artery ablation; Renal artery ablation with the EnligHTN™ Renal Denervation System	Device: Renal Artery Ablation; Renal artery denervation using the EnligHTN™ Renal Denervation System; Device: Cardiac Ablation; 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
Active Comparator: Cardiac ablation	Device: Cardiac Ablation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	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).	6 months and 12 months post procedure
Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months		Baseline and 6 months
Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months		Baseline and 12 months
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)	3 months, 6 months, 12 months, 24 months
Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg		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)	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)	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)	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).	Baseline and 24 months post procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Christopher Piorkowski, MD, Herzzentrum Dresden GmbH Universitätsklinik

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2014
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): October 15, 2018

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: SJM-CIP-0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO