CVRx Barostim Hypertension Pivotal Trial
This study is currently recruiting participants.
Verified May 2013 by CVRx, Inc.
Information provided by (Responsible Party):
First received: August 31, 2012
Last updated: May 16, 2013
Last verified: May 2013
The Barostim™ Hypertension Pivotal Trial is a prospective, randomized, controlled trial to demonstrate the safety and efficacy of the Barostim Neo system in subjects with resistant hypertension.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CVRx Barostim Hypertension Pivotal Trial|
Resource links provided by NLM:
Drug Information available for: Phenylephrine Phenylephrine hydrochloride Oxymetazoline Oxymetazoline hydrochlorideU.S. FDA Resources
Further study details as provided by CVRx, Inc.:
Primary Outcome Measures:
- Primary Safety Objective [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]To demonstrate the safety of the Neo system by reporting all adverse events that are complications between implant and 30 days post-implant in the device arm. The incidence of adverse events will be categorized by relatedness.
- Primary Efficacy Objective [ Time Frame: 6 months ] [ Designated as safety issue: No ]To demonstrate a significant reduction between the two treatment arms of protocol defined automated office cuff systolic blood pressure (SBP) from baseline to 6 months post-activation.
Secondary Outcome Measures:
- Secondary Efficacy Objective 1 [ Time Frame: 12 months ] [ Designated as safety issue: No ]To demonstrate a significant reduction within the device arm of office cuff systolic blood pressure (SBP) between baseline and 12 months post-activation.
- Secondary Efficacy Objective 2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]To demonstrate a significant reduction within the device arm of 24-hour ambulatory systolic blood pressure (SBP) between baseline and 12 months post-activation.
- Secondary Safety Objective [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]To demonstrate the safety of the Neo system by reporting all hypertensive emergencies from activation to 6 months post activation. The incidence of hypertensive emergencies will be categorized by study arm.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Neo Baroreflex Activation Therapy System
Patients are randomized to receive Neo Baroreflex Activation Therapy System device plus optimal medical management.
Device: Neo Baroreflex Activation Therapy System
No Intervention: Medical Management Arm
Patients are randomized to receive optimal medical management alone.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679132
|Contact: Tom Moorefirstname.lastname@example.org|
|United States, California|
|University of Southern California||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Christian Romero 323-442-5322 email@example.com|
|Principal Investigator: Karen Woo|
|United States, Florida|
|Florida Hospital Cardiovascular Institute||Recruiting|
|Orlando, Florida, United States, 32803|
|Contact: Carol Stastny 407-303-5600 ext 1103439 firstname.lastname@example.org|
|Principal Investigator: Harischandra Karunaratne|
|United States, Louisiana|
|Cardiovascular Institute of the South||Recruiting|
|Houma, Louisiana, United States, 70361|
|Contact: Deanna Benoit 985-873-5613 email@example.com|
|Principal Investigator: Richard Abben|
|United States, Pennsylvania|
|Allegheny General Hospital||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15212|
|Contact: Sheila Bernardini 412-359-5600 ext 1103439 firstname.lastname@example.org|
|Principal Investigator: Srinivas Murali|
|United States, Wisconsin|
|Aspirus Wausau Hospital||Recruiting|
|Wausau, Wisconsin, United States, 54401|
|Contact: Jeff Kaliebe 715-847-2273 ext 52639 email@example.com|
|Principal Investigator: German Larrain|
Sponsors and Collaborators
|Study Chair:||George Bakris, MD||The University of Chicago Medicine|
|Study Chair:||John Bisognano, MD||University of Rochester|
|Study Chair:||Fred Weaver, MD||Keck School of Medicine of the University of Southern California|
|Study Chair:||William Abraham, MD||Ohio State University|