Clinical trial NCT02064764: Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
Official title: Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Hypertension
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Subjects in Each Arm That Experience Safety Composite Events
timeFrame: Up to one or six months post procedure depending on the event
measure: Proportion of Patients With Chronic Treatment Success
timeFrame: Minimum of six months
Secondary outcomes:
measure: Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline
timeFrame: 6 months
measure: Difference in Heart Rate at 6 Months and Baseline
timeFrame: 6 months
measure: Procedural Measures
timeFrame: Procedure
measure: Proportion of Participants With Symptoms at 6 Months Between Study Arms
timeFrame: 6 months
measure: Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period.
timeFrame: 6 months
measure: Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period
timeFrame: 91 days after the cryoablation procedure date until the last Reveal LINQ device data date.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Mercy Medical Group-Cardiology
state: California
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Marquette
country: United States
facility: UPHS-Marquette
state: Michigan
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center Cherry Hill
state: Washington
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
Study officials:
affiliation: NYU Langone Health
name: Larry Chinitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Younis A, Steinberg JS. Renal Denervation for Patients With Atrial Fibrillation. Curr Cardiol Rep. 2021 Jul 16;23(9):126. doi: 10.1007/s11886-021-01558-4.