Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. To assess safety, the study will measure the occurrence of a composite safety endpoint and, to assess effectiveness, the study will measure freedom of chronic treatment failure through a minimum of six months of follow-up.

Official Title
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Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation, Hypertension

Intervention / Treatment
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* Device: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter
* Device: Arctic Front Advance™ Cardiac Cryoablation System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Drug refractory recurrent symptomatic paroxysmal or persistent atrial fibrillation Office-based systolic blood pressure of ≥140 mm Hg based despite treatment with 1 or more antihypertensive medications Age 18 years to 80 years old. Key Exclusion Criteria: Renal artery anatomy that is ineligible for treatment including: Lacks at least one renal artery for each kidney with ≥3 mm diameter and minimum treatable length per the Spyral Instructions for Use, Renal artery stenosis (>50%) or renal artery aneurysm in either renal artery, A history of prior renal artery intervention including balloon angioplasty or stenting, Renal artery which contain calcification which does not allow at least four radio frequency ablations to be delivered , Diffuse fibromuscular dysplasia (FMD) or FMD which does not allow at least four radio frequency ablations to be delivered; FMD defined as visible beading of the artery on angiography , Unilateral kidney. Estimated Glomerular Filtration Rate of <30 mL/min/1.73m2. Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography). Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cryoablation only<br>Pulmonary vein isolation | Device: Arctic Front Advance™ Cardiac Cryoablation System<br> <br> |
| Experimental: Cryoablation and renal nerve denervation<br>Pulmonary vein isolation plus renal nerve denervation | Device: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter<br> <br> Device: Arctic Front Advance™ Cardiac Cryoablation System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety composite events | The objective characterizes the rate of safety composite events, adjudicated as a serious adverse event, within each of the two study arms and also characterizes the difference in the rates between study arms. Each event in the composite has its own time frame, either one month or six months post procedure. | Up to one or six months post procedure depending on the event | 
| Rate of chronic treatment success between study arms | Chronic treatment success is freedom from chronic treatment failure. Chronic treatment failure is defined as the occurrence of either a documented episode of AF lasting 30 seconds or longer or an intervention for AF. | Minimum of six months |