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

N/ACompletedNCT02064764

Medtronic Vascular102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Atrial Fibrillation Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (10)

Mercy Medical Group-Cardiology

Sacramento, California, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

UPHS-Marquette

Marquette, Michigan, United States

NYU Langone Medical Center

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Doylestown Hospital

Doylestown, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Swedish Medical Center Cherry Hill

Seattle, Washington, United States

Universitätsklinikum des Saarlandes

Homburg, Germany

Outcomes

Primary Outcomes

Proportion of Subjects in Each Arm That Experience Safety Composite Events

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.

Time frame: Up to one or six months post procedure depending on the event

Proportion of Patients With Chronic Treatment Success

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.

Time frame: Minimum of six months

Secondary Outcomes

Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline

Compare the difference of office systolic and diastolic blood pressure at 6 months and baseline between study arms.

Time frame: 6 months

Difference in Heart Rate at 6 Months and Baseline

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.

Time frame: 6 months

Procedural Measures

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.

Time frame: Procedure

Proportion of Participants With Symptoms at 6 Months Between Study Arms

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

Time frame: 6 months

Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period.

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.

Time frame: 6 months

Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period

Compare the Percent of time in AF burden over all follow-up occurring after the blanking period between study arms.

Time frame: 91 days after the cryoablation procedure date until the last Reveal LINQ device data date.