CVRx Barostim Hypertension Pivotal Trial
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by CVRx, Inc.
Sponsor:
CVRx, Inc.
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT01679132
First received: August 31, 2012
Last updated: February 4, 2015
Last verified: February 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Uncontrolled Hypertension |
Device: Neo Baroreflex Activation Therapy System |
| Study Type: | Interventional |
| 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:
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.
| Estimated Enrollment: | 310 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Names:
|
|
No Intervention: Medical Management Arm
Patients are randomized to receive optimal medical management alone.
|
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria Highlights:
- Age at least 21 years and no more than 80 years at the time of randomization.
- On four or more maximally tolerated anti-hypertensive medications, one of which is a diuretic. The antihypertensive medication regimen must remain unchanged for 4 weeks prior to screening and must be expected to remain unchanged for at least 6 months during follow-up.
- Protocol defined systolic blood pressure greater than or equal to 160 mmHg.
- Protocol defined 24-hour Ambulatory Blood Pressure Monitoring (ABPM) greater than or equal to 135 mmHg.
- Serum estimated glomerular filtration rate (eGFR) > 29 mL/min/1.73 m^2.
- Appropriate surgical candidate.
- Women of childbearing potential must use a medically accepted method of birth control and agree to continue use of this method for the duration of the study. Women of childbearing potential must have a negative pregnancy test within 14 days prior to randomization.
Exclusion Criteria Highlights:
- Known or suspected baroreflex failure or autonomic neuropathy.
- Myocardial infarction, hypertensive crisis, symptomatic orthostatic hypotension, unstable angina, syncope, or cerebral vascular accident within the 3 months.
- Hypertension secondary to an identifiable and treatable cause other than sleep apnea.
- Prior surgery, radiation, or endovascular stent placement in the carotid sinus region.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679132
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679132
Contacts
| Contact: Tom Moore | 763-416-2352 | tmoore@cvrx.com |
Locations
| United States, Arizona | |
| Arizona Heart Rhythm Research Center | Recruiting |
| Phoenix, Arizona, United States, 85006 | |
| Contact: Wendy Schwoegler 602-456-2342 wschwoegler@azheartrythm.com | |
| Principal Investigator: Vijay Swarup | |
| United States, California | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Christian Romero 323-442-5322 romeroch@usc.edu | |
| Principal Investigator: Karen Woo | |
| United States, District of Columbia | |
| George Washington University | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact: Cathy Garey 202-741-3168 cgarey@mfa.gwu.edu | |
| Principal Investigator: Gregory Trachiotis | |
| United States, Florida | |
| Florida Hospital Cardiovascular Institute | Recruiting |
| Orlando, Florida, United States, 32803 | |
| Contact: Carol Stastny 407-303-5600 ext 1103439 carol.stastny@flhosp.org | |
| Principal Investigator: Harischandra Karunaratne | |
| Florida Cardiovascular Institute | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Courtney Lee 813-353-8535 courtneyelee@tgh.org | |
| Principal Investigator: Fadi Matar | |
| United States, Louisiana | |
| Cardiovascular Institute of the South | Recruiting |
| Houma, Louisiana, United States, 70361 | |
| Contact: Deanna Benoit 985-873-5613 deanna.benoit@cardio.com | |
| Principal Investigator: Richard Abben | |
| United States, Michigan | |
| Cardiac and Vascular Research Center of Northern Michigan | Recruiting |
| Petosky, Michigan, United States, 49770 | |
| Contact: Jennifer LaLonde 231-487-9185 jlalonde@cvrcnm.com | |
| Principal Investigator: Harry Colfer | |
| Michigan CardioVascular Institute | Recruiting |
| Saginaw, Michigan, United States, 48601 | |
| Contact: Tacey Gauthier 989-907-8031 tgauthier@mcvi.com | |
| Principal Investigator: Naveed Akhtar | |
| United States, Nevada | |
| University Medical Center of Southern Nevada | Recruiting |
| Las Vegas, Nevada, United States, 89102 | |
| Contact: Luzviminda Dizon 702-383-2585 luzviminda.dizon@umcsn.com | |
| Principal Investigator: Chowdhury Ahsan | |
| United States, Oklahoma | |
| Oklahoma Heart hospital | Recruiting |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Contact: Bonnie Miller 405-608-1280 bmiller@okheart.com | |
| Principal Investigator: Branislov Schifferdecker | |
| United States, Pennsylvania | |
| Allegheny General Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Sheila Bernardini 412-359-5600 ext 1103439 sbernard@wpahs.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 jeff.kaliebe@aspirus.org | |
| Principal Investigator: German Larrain | |
Sponsors and Collaborators
CVRx, Inc.
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | CVRx, Inc. |
| ClinicalTrials.gov Identifier: | NCT01679132 History of Changes |
| Other Study ID Numbers: | 360039 |
| Study First Received: | August 31, 2012 |
| Last Updated: | February 4, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by CVRx, Inc.:
|
Hypertension High Blood Pressure Blood Pressure Cardiovascular Disease Resistant Hypertension |
Additional relevant MeSH terms:
|
Hypertension Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015