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Trial record 1 of 3 for:    SYMPLICITY AF
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Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation (Symplicity AF)

This study is currently recruiting participants.
Verified October 2017 by Medtronic Atrial Fibrillation Solutions
Sponsor:
ClinicalTrials.gov Identifier:
NCT02064764
First Posted: February 17, 2014
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
February 13, 2014
February 17, 2014
October 20, 2017
February 2015
January 2019   (Final data collection date for primary outcome measure)
  • Safety composite events [ Time Frame: Up to one or six months post procedure depending on the event ]
    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 ]
    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.
Same as current
Complete list of historical versions of study NCT02064764 on ClinicalTrials.gov Archive Site
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Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Hypertension
  • Drug: Renal nerve denervation
    Other Name: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter
  • Device: Cryoablation
    Other Name: Arctic Front Advance™ Cardiac Cryoablation System
  • Active Comparator: Cryoablation only
    Pulmonary vein isolation
    Intervention: Device: Cryoablation
  • Experimental: Cryoablation and renal nerve denervation
    Pulmonary vein isolation plus renal never denervation
    Interventions:
    • Drug: Renal nerve denervation
    • Device: Cryoablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
245
June 2019
January 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Dana Wigert 763-526-2802 dana.wigert@medtronic.com
Contact: Kristy Simmons 763-526-2353 kristy.simmons@medtronic.com
United States
 
 
NCT02064764
Symplicity AF
Yes
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Medtronic Atrial Fibrillation Solutions
Medtronic Atrial Fibrillation Solutions
Not Provided
Principal Investigator: Larry Chinitz, MD New York University School of Medicine
Medtronic Atrial Fibrillation Solutions
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP