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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 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: August 15, 2014
Last verified: August 2014
  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 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: 265
Study Start Date: November 2014
Estimated Primary Completion Date: March 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™ Renal Denervation System
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

Inclusion Criteria:

  • Drug refractory recurrent symptomatic paroxysmal atrial fibrillation. Drug refractory is defined as: failed (drug is ineffective or patient is intolerant) at least one Class I or III anti-arrhythmic drug.
  • Office-based systolic blood pressure of ≥150 mm Hg based on average of three blood pressure readings despite treatment with 2 or more antihypertensive medications of different classes (one of these must be a diuretic) at highest labeled dose according to the medication's labeling, highest usual dose per clinical guidelines (i.e., JNC-7 Guidelines), highest tolerated dose or highest appropriate dose for the subject per the Principal Investigator's best clinical judgment.
  • Ambulatory Blood Pressure Monitoring 24 hour average systolic blood pressure ≥135 mmHg.
  • Age 18 years to 80 years old.
  • Willing to give informed consent and agree to all study procedures, and is competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

  • Active systemic infection
  • Condition where manipulation of the catheter within the heart would be unsafe (e.g. intracardiac mural thrombus).
  • Cryoglobulinemia
  • One or more pulmonary vein stents
  • Type I Diabetes
  • NYHA Class IV heart failure with in the past 6 months
  • Renal artery anatomy that is ineligible for treatment including: a) Lacks at least one renal artery for each kidney with ≥4 mm diameter and with ≥20 mm treatable length prior to a significant arterial branch (NOTE: All renal arteries with ≥4 mm diameter and with ≥20 mm treatable length should be treated, including dual renal arteries meeting these morphologic criteria.). b) Renal artery stenosis (>50%) or renal artery aneurysm in either renal artery. c) A history of prior renal artery intervention including balloon angioplasty or stenting. d) Renal arteries which contain calcification which does not allow at least four radio frequency ablations to be delivered. e) 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. f) Unilateral kidney.
  • Estimated Glomerular Filtration Rate of <30 mL/min/1.73m2.
  • Primary pulmonary hypertension.
  • Pheochromocytoma, Cushing's Disease, coarctation of the aorta, untreated hyperthyroidism, primary hyperparathyroidism or hyperaldosteronism (Note: treated hyperthyroidism is permissible).
  • Myocardial infarction, unstable angina pectoris, syncope, PCI/PTCA, or coronary artery stenting within 3 months prior to signing the consent form, or has widespread atherosclerosis with documented intravascular thrombosis or unstable plaques.
  • Cerebrovascular accident or TIA within 1 month prior to signing the consent form.
  • Prior ablation for atrial fibrillation in the left atrium.
  • Presence of a permanent pacemaker, biventricular pacemaker, loop recorder, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function).
  • Cardiac valve stenosis for which a significant reduction of blood pressure is contraindicated.
  • A condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic blood pressure monitor (e.g., arm diameter too large for the cuff).
  • Serious medical condition, which may adversely affect the safety and/or effectiveness of the participant or the trial (e.g., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia).
  • 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).
  • Known history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
  • Previous organ transplant.
  • 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

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: August 15, 2014
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 November 25, 2014