Renal Nerve Denervation in Patients With Hypertension and Paroxysmal Atrial Fibrillation (Symplicity AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Medtronic Atrial Fibrillation Solutions
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT02064764
First received: February 13, 2014
Last updated: February 10, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Hypertension
Drug: Renal nerve denervation
Device: Cryoablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Nerve Denervation in Patients With Hypertension and Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:
  • Safety composite events [ Time Frame: Up to one or six months post procedure depending on the event ] [ Designated as safety issue: No ]
    The objective characterizes the rate of safety composite events, adjudicated as a serious adverse event, within each of the two study arms and also characterizes 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.

  • Rate of chronic treatment success between study arms [ Time Frame: Minimum of six months ] [ Designated as safety issue: No ]
    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 30 seconds or longer or an intervention for AF.


Estimated Enrollment: 245
Study Start Date: February 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cryoablation only
Pulmonary vein isolation
Device: Cryoablation
Other Name: Arctic Front Advance™ Cardiac Cryoablation System
Experimental: Cryoablation and renal nerve denervation
Pulmonary vein isolation plus renal never denervation
Drug: Renal nerve denervation
Other Name: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter
Device: Cryoablation
Other Name: Arctic Front Advance™ Cardiac Cryoablation System

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Drug refractory recurrent symptomatic paroxysmal or persistent atrial fibrillation
  • Office-based systolic blood pressure of ≥150 mm Hg based despite treatment with 2 or more antihypertensive medications of different classes (one of these must be a diuretic)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064764

Contacts
Contact: Dana Wigert 763-526-2802 dana.wigert@medtronic.com
Contact: William Prather 763-514-9897 william.c.prather@medtronic.com

Locations
United States, New York
NYU Langone Medical Center Not yet recruiting
New York, New York, United States, 10016
Contact: Larry Chinitz, MD    212-263-7149    larry.chinitz@nyumc.org   
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Ralph Augostini, MD    614-293-4967    Ralph.augostini@osumc.edu   
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Investigators
Principal Investigator: Larry Chinitz, MD New York University Langone Medical Center
  More Information

No publications provided

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT02064764     History of Changes
Other Study ID Numbers: Symplicity AF
Study First Received: February 13, 2014
Last Updated: February 10, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Hypertension
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on March 30, 2015