Overview

This trial is active, not recruiting.

Conditions persistent atrial fibrillation, paroxysmal atrial fibrillation, hypertension
Treatments renal artery ablation, cardiac ablation
Sponsor St. Jude Medical
Start date July 2013
End date August 2017
Trial size 61 participants
Trial identifier NCT01907828, SJM-CIP-0009

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Renal artery ablation with the EnligHTN™ Renal Denervation System
renal artery ablation
Renal artery denervation using the EnligHTN™ Renal Denervation System
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
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

Primary Outcomes

Measure
Freedom from atrial fibrillation in patients with hypertension
time frame: 12 months

Secondary Outcomes

Measure
Major adverse cardiac events
time frame: 7 days, 6 months, and 12 months post procedure
Percent of patients who experience a procedural related event
time frame: 30 days post procedure
Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation
time frame: 6 months, 12 months
Renal function change based on eGFR (renal denervation group only)
time frame: 6 months,12 months
Recurrence of AF based on electrocardiographic data up to 2 years following the initial cardiac ablation procedure.
time frame: 2 years
Percentage of subjects achieving office Systolic Blood Pressure < 140
time frame: 6 months post procedure
Change in Office and Ambulatory Blood Pressure parameters
time frame: 6 month, 12 month, 24 month post procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
Principal investigator Christopher Piorkowski, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.