BAROSTIM NEO Hypertension Pivotal Trial

• ClinicalTrials.gov Identifier: NCT01679132
• Recruitment Status: Suspended
• First Posted: September 5, 2012
• Last Update Posted: September 10, 2019
• Sponsor: CVRx, Inc.
• Information provided by (Responsible Party): CVRx, Inc.

Tracking Information

• First Submitted Date: August 31, 2012
• First Posted Date: September 5, 2012
• Last Update Posted Date: September 10, 2019
• Study Start Date: April 12, 2013
• Estimated Primary Completion Date: March 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2019)

To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System. [ Time Frame: For the duration of the study, up to ten years. ]

Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.

Original Primary Outcome Measures (submitted: August 31, 2012)

• To demonstrate the safety of the Neo system by evaluating the Type 1 system and procedure related complication free rate through 30 days post-procedure. [ Time Frame: 30 days ]
• To demonstrate a significant reduction of BpTRU systolic blood pressure (SBP) at 3 months post activation. [ Time Frame: 3 months ]

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: August 31, 2012)

• To demonstrate a significant reduction of BpTRU systolic blood pressure (SBP) at 6 months post activation. [ Time Frame: 6 months ]
• To demonstrate a significant reduction of 24-hour ambulatory systolic blood pressure (SBP) at 6 months post-activation. [ Time Frame: 6 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: BAROSTIM NEO Hypertension Pivotal Trial
• Official Title: BAROSTIM NEO Hypertension Pivotal Trial
• Brief Summary: The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).

Detailed Description

The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.

All subjects are now in long term follow-up and are required to have at least one annual visit.

Parameters assessed during visits are:

• Office Cuff Blood Pressure
• Physical Assessment
• Subject Medications
• Serious adverse events

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Uncontrolled Hypertension

Intervention

Device: BAROSTIM NEO System and Medical Management

Experimental: Device and Medical Management

Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators.

Other Name: Neo System

Study Arms

Experimental: BAROSTIM NEO System

Subjects implanted with the BAROSTIM NEO System.

Intervention: Device: BAROSTIM NEO System and Medical Management

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Actual Enrollment (submitted: September 6, 2019): 10
• Original Estimated Enrollment (submitted: August 31, 2012): 600
• Estimated Study Completion Date: March 2026
• Estimated Primary Completion Date: March 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.
• Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria:

• Treating physician decision that the subject should not continue with therapy.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01679132
• Other Study ID Numbers: 360039
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Responsible Party: CVRx, Inc.
• Study Sponsor: CVRx, Inc.
• Collaborators: Not Provided

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

• PRS Account: CVRx, Inc.
• Verification Date: September 2019