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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)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02064764
Recruitment Status : Active, not recruiting
First Posted : February 17, 2014
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Hypertension Device: Renal nerve denervation Device: Cryoablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
Actual Study Start Date : February 2015
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

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Arm Intervention/treatment
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 nerve denervation
Device: Renal nerve denervation
Other Name: Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter

Device: Cryoablation
Other Name: Arctic Front Advance™ Cardiac Cryoablation System




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064764


Locations
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United States, California
Mercy Medical Group-Cardiology
Sacramento, California, United States, 95819
United States, Massachusetts
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Michigan
UPHS-Marquette
Marquette, Michigan, United States, 49855
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Swedish Medical Center Cherry Hill
Seattle, Washington, United States, 98122-5711
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum des Saarlandes
Homburg, Germany, 66421
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Larry Chinitz, MD NYU Langone Health
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02064764    
Other Study ID Numbers: Symplicity AF
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hypertension
Atrial Fibrillation
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes