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Trial record 1 of 1 for:    NCT02439749
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SPYRAL HTN-OFF MED Study

This study is currently recruiting participants.
Verified November 2017 by Medtronic Vascular
Sponsor:
ClinicalTrials.gov Identifier:
NCT02439749
First Posted: May 12, 2015
Last Update Posted: November 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 Vascular
  Purpose
The purpose of this study is to obtain an assessment of the efficacy and safety of renal denervation in the absence of antihypertensive medications.

Condition Intervention
Hypertension Vascular Diseases Cardiovascular Diseases Device: Symplicity Spyral™ multi-electrode renal denervation system Procedure: Sham Procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL HTN-OFF MED)

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Acute and chronic safety by evaluating incidence of Major Adverse Events [ Time Frame: From baseline to 36 months post-procedure ]
  • Change in systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 36 months post-procedure ]

Secondary Outcome Measures:
  • Change in office systolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  • Incidence of achieving target office systolic blood pressure (SBP<140 mmHg or <130 mmHg for patients with diabetes or renal disease) [ Time Frame: From 1 month to 36 months post-procedure ]
  • Change in office diastolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  • Change in diastolic blood pressure as measured by 24-hour ABPM [ Time Frame: From baseline to 36 months post-procedure ]

Estimated Enrollment: 170
Actual Study Start Date: June 2015
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Device: Symplicity Spyral™ multi-electrode renal denervation system
After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Other Names:
  • Renal angiography
  • Renal Denervation
Sham Comparator: Sham Procedure
Renal angiography
Procedure: Sham Procedure
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Other Name: Renal angiography

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
  • Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.
  • Individual is willing to discontinue current antihypertensive medications.

Exclusion Criteria:

  • Individual lacks appropriate renal artery anatomy.
  • Individual has estimated glomerular filtration rate (eGFR) of <45.
  • Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
  • Individual has one or more episodes of orthostatic hypotension.
  • Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
  • Individual has primary pulmonary hypertension.
  • Individual is pregnant, nursing or planning to become pregnant.
  • Individual is being treated chronically (e.g. daily use) with non-steroidal anti-inflammatory drugs (NSAIDs). Aspirin therapy is allowed.
  • Individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within three months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
  • Individual works night shifts.
  Contacts and Locations
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): NCT02439749


Contacts

  Show 25 Study Locations
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Raymond Townsend, MD University of Pennsylvania
Principal Investigator: David Kandzari, MD Piedmont Hospital
Principal Investigator: Michael Böhm, MD Universitätskliniken des Saarlandes
Principal Investigator: Kazuomi Kario, MD Jichi Medical University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT02439749     History of Changes
Other Study ID Numbers: SPYRAL HTN-OFF MED
First Submitted: April 28, 2015
First Posted: May 12, 2015
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by Medtronic Vascular:
Uncontrolled hypertension
Renal denervation

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases