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

NCT02064764 | Completed Results DMC FDA Device

• 1 other identifier: Symplicity AF
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 10

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Minimum of six months

Secondary Outcomes (6)

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

  6 months

• Difference in Heart Rate at 6 Months and Baseline

  6 months

• Procedural Measures

  Procedure

• Proportion of Participants With Symptoms at 6 Months Between Study Arms

  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.

  6 months

Study Arms (2)

Cryoablation only

ACTIVE COMPARATOR

Pulmonary vein isolation

Device: Arctic Front Advance™ Cardiac Cryoablation System

Cryoablation and renal nerve denervation

EXPERIMENTAL

Pulmonary vein isolation plus renal nerve denervation

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

Interventions

Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter DEVICE

Cryoablation and renal nerve denervation

Arctic Front Advance™ Cardiac Cryoablation System DEVICE

Cryoablation and renal nerve denervation; Cryoablation only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (10)

Mercy Medical Group-Cardiology

Sacramento, California, 95819, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

UPHS-Marquette

Marquette, Michigan, 49855, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Swedish Medical Center Cherry Hill

Seattle, Washington, 98122-5711, United States

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Related Publications (1)

• 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.

  PMID: 34269911 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Results Point of Contact

• Title: Vanessa DeBruin
• Organization: Medtronic, Inc.

vanessa.debruin@medtronic.com

6123607687

Study Officials

• Larry Chinitz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2015
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: February 23, 2024
• Results First Posted: February 23, 2024

Record last verified: 2024-01

Locations

US (9); DE (1)