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

Not Applicable

Completed

Conditions: Atrial Fibrillation
Hypertension

Interventions: Device: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter
Device: Arctic Front Advance™ Cardiac Cryoablation System

Registration Number: NCT02064764

Lead Sponsor: Medtronic Vascular

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoablation and renal nerve denervation	Arctic Front Advance™ Cardiac Cryoablation System	Pulmonary vein isolation plus renal nerve denervation
Cryoablation and renal nerve denervation	Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter	Pulmonary vein isolation plus renal nerve denervation
Cryoablation only	Arctic Front Advance™ Cardiac Cryoablation System	Pulmonary vein isolation

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Chronic Treatment Success	Minimum of six months	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 2 or more minutes (as measured by an implantable loop recorder) or an intervention for AF.
Proportion of Subjects in Each Arm That Experience Safety Composite Events	Up to one or six months post procedure depending on the event	Characterize the rate of safety composite events, (End stage renal disease, Death, Significant Embolic Event, Renal Artery Perforation or Dissection Requiring Intervention, Vascular Complications, Hospitalization for Hypertensive Crisis, New Renal Artery Stenosis, Cardiac Damage, Pulmonary Vein Stenosis, Atrio-Esophageal Fistula, Arrhythmia, Persistent Phrenic Nerve Palsy), within each of the two study arms and also characterize 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.

Secondary Outcome Measures

Name	Time	Method
Procedural Measures	Procedure	Elapsed fluoroscopy time and cryocatheter procedure time between study arms. Renal Denervation Procedure Time and Total Procedural Time will be reported only for the Cryoablation and Renal Denervation group.
Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline	6 months	Compare the difference of office systolic and diastolic blood pressure at 6 months and baseline between study arms.
Proportion of Participants With Symptoms at 6 Months Between Study Arms	6 months	The endpoints for this objective are presence of the following arrhythmic symptoms as recorded at the 6-month visit through discussion with the patient at the time of the visit: * Dizziness * Palpitations * Rapid heart beat * Dyspnea * Fatigue * Syncope * Other
Difference in Heart Rate at 6 Months and Baseline	6 months	Compare the difference in heart rate using the 6 month follow-up measurement and baseline visit measurement. These values will then be compared between study arms.
Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period.	6 months	Compare the rate of chronic treatment success (primary effectiveness endpoint) between study arms for subjects off of Class I and III anti-arrhythmic drugs following the blanking period.
Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period	91 days after the cryoablation procedure date until the last Reveal LINQ device data date.	Compare the Percent of time in AF burden over all follow-up occurring after the blanking period between study arms.

Trial Locations

Locations (10): The Ohio State University
🇺🇸
Columbus, Ohio, United States
Mercy Medical Group-Cardiology
🇺🇸
Sacramento, California, United States
Lahey Hospital and Medical Center
🇺🇸
Burlington, Massachusetts, United States
Virginia Mason Medical Center
🇺🇸
Seattle, Washington, United States
Doylestown Hospital
🇺🇸
Doylestown, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Swedish Medical Center Cherry Hill
🇺🇸
Seattle, Washington, United States
Universitätsklinikum des Saarlandes
🇩🇪
Homburg, Germany
NYU Langone Medical Center
🇺🇸
New York, New York, United States
UPHS-Marquette
🇺🇸
Marquette, Michigan, United States