Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension (WAVE_IV)
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ClinicalTrials.gov Identifier: NCT02029885 |
Recruitment Status : Unknown
Verified January 2016 by Kona Medical Inc..
Recruitment status was: Recruiting
First Posted : January 8, 2014
Last Update Posted : January 8, 2016
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Sponsor:
Kona Medical Inc.
Information provided by (Responsible Party):
Kona Medical Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | January 6, 2014 | |||
First Posted Date ICMJE | January 8, 2014 | |||
Last Update Posted Date | January 8, 2016 | |||
Study Start Date ICMJE | August 2014 | |||
Estimated Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Safety at 3 weeks follow-up [ Time Frame: 3 weeks ] Safety will be assessed by incidence of Major Adverse Events (MAE), defined as a composite of the following events at 3-weeks follow-up.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Change in ABPM [ Time Frame: 6 months ] Change in average 24-hour ambulatory blood pressure from screening to the 6 month follow-up visit
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Original Secondary Outcome Measures ICMJE |
Efficacy [ Time Frame: 24 months ] Long term performance (efficacy) is evaluated by comparing the change in Office Systolic blood pressure from screening through the 24-month evaluation
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
Long term Safety [ Time Frame: 24 months ] Chronic safety is assessed by incidence and evaluation by any serious adverse events associated with the Kona Medical Surround Sound non-invasive system through the 24 week follow-up period
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Descriptive Information | ||||
Brief Title ICMJE | Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension | |||
Official Title ICMJE | Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension | |||
Brief Summary | To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension. | |||
Detailed Description | This study is a sham controlled, double blind study of subjects with uncontrolled hypertension consisting of two arms, sham and therapy. Bilateral renal denervation will be performed non-invasively using the Kona Medical Surround Sound System which delivers focused ultrasound therapy to ablate the nerves surrounding the renal artery utilizing real time ultrasound for targeting and tracking. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Saxena M, Shour T, Shah M, Wolff CB, Julu POO, Kapil V, Collier DJ, Ng FL, Gupta A, Balawon A, Pheby J, Zak A, Rull G, O'Brien B, Schmieder RE, Lobo MD. Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success. J Am Heart Assoc. 2018 Jun 12;7(12):e009151. doi: 10.1161/JAHA.118.009151. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
132 | |||
Original Estimated Enrollment ICMJE |
50 | |||
Estimated Study Completion Date ICMJE | March 2018 | |||
Estimated Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Austria, Colombia, Czech Republic, Germany, New Zealand, Poland, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02029885 | |||
Other Study ID Numbers ICMJE | KM14-001 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Kona Medical Inc. | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Kona Medical Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Kona Medical Inc. | |||
Verification Date | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |