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

NCT ID: NCT02064764

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2021-04-19

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.

Conditions

Atrial Fibrillation; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoablation only

Pulmonary vein isolation

Group Type: ACTIVE_COMPARATOR

Arctic Front Advance™ Cardiac Cryoablation System

Intervention Type: DEVICE

Cryoablation and renal nerve denervation

Pulmonary vein isolation plus renal nerve denervation

Group Type: EXPERIMENTAL

Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter

Intervention Type: DEVICE

Arctic Front Advance™ Cardiac Cryoablation System

Intervention Type: DEVICE

Interventions

Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter

Intervention Type: DEVICE

Arctic Front Advance™ Cardiac Cryoablation System

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry Chinitz, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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

Countries

United States; Germany

References

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.

Reference Type: DERIVED

PMID: 34269911 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Symplicity AF

Identifier Type: -

Identifier Source: org_study_id