Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)

January 21, 2023 updated by: CVRx, Inc.

Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System

The purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Summary:

The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the registry.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Recruiting
        • Grandview Medical Center
        • Contact:
        • Principal Investigator:
          • Anil Rajendra
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Chan Heart Rhythm Institute
        • Contact:
        • Principal Investigator:
          • Rodrigo Chan
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Principal Investigator:
          • Michael Fong
      • Norco, California, United States, 92860
        • Recruiting
        • Dr. Truong Duong a Medical Corporation
        • Contact:
        • Principal Investigator:
          • Truong Duong
      • Oxnard, California, United States, 93030
        • Recruiting
        • Cabrillo Cardiology Research Group
        • Contact:
        • Principal Investigator:
          • Richard Rothschild
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • The George Washington University Medical Faculty Associates
        • Contact:
        • Principal Investigator:
          • Gurusher Panjrath
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Recruiting
        • Orlando Heart and Vascular Institute
        • Contact:
        • Principal Investigator:
          • Nandkishore Ranadive
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • CardioVascular Solutions Institute
        • Contact:
        • Principal Investigator:
          • Gino Sedillo
      • Cape Coral, Florida, United States, 33914
        • Recruiting
        • Cardiac Care Group
        • Contact:
        • Principal Investigator:
          • Joseph Freedman
      • Daytona Beach, Florida, United States, 32114
        • Recruiting
        • Daytona Heart Group
        • Contact:
        • Principal Investigator:
          • Surya Rao
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Florida Heart Rhythm Specialists
        • Contact:
        • Principal Investigator:
          • David Kenigsberg
      • Naples, Florida, United States, 34119
        • Recruiting
        • Naples Heart Rhythm Specialists, PA
        • Contact:
        • Principal Investigator:
          • Kenneth Plunkett
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Contact:
        • Principal Investigator:
          • Hector Lozano
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Cardiovascular Interventions
        • Contact:
        • Principal Investigator:
          • Pradipkumar Jamnadas
    • Nevada
      • Las Vegas, Nevada, United States, 89118
        • Recruiting
        • Nevada Heart and Vascular Center
        • Contact:
        • Principal Investigator:
          • Sanjay Malhorta
    • New Jersey
      • Glen Ridge, New Jersey, United States, 07028
        • Recruiting
        • DeGregorio Cardiology
        • Contact:
        • Principal Investigator:
          • Asad Cheema
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • Valley Hospital
        • Contact:
        • Principal Investigator:
          • Suneet Mittal
      • S. River, New Jersey, United States, 08882
        • Recruiting
        • Cardio Vascular Health Associates
        • Contact:
        • Principal Investigator:
          • Rakesh Passi
    • New York
      • Albany, New York, United States, 12211
        • Recruiting
        • Capital Cardiology
        • Contact:
        • Principal Investigator:
          • Rizwan Alimohammad
      • Kew Gardens, New York, United States, 11415
        • Recruiting
        • Marian David, M.D., P.C
        • Contact:
        • Principal Investigator:
          • Marian David
    • Virginia
      • Manassas, Virginia, United States, 20109
        • Recruiting
        • Carient Heart & Vascular
        • Contact:
        • Principal Investigator:
          • Aysha Arshad
    • Wisconsin
      • Weston, Wisconsin, United States, 54479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients can be included in the registry if they were implanted with a de novo Barostim System.

Description

Inclusion Criteria:

  • Patients can be included in the registry if they were implanted with a de novo Barostim System. Patients must sign an informed consent form after implantation with the Barostim System in order to participate in the registry.

Indications:

The Barostim System is indicated for the improvement of symptoms of heart failure - quality of life, six-minute hall walk and functional status - for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

Contraindications:

  • Bilateral carotid bifurcations located above the level of the mandible
  • Baroreflex failure or autonomic neuropathy
  • Uncontrolled, symptomatic cardiac bradyarrhythmias
  • Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation greater than 50%
  • Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
  • Known allergy to silicone or titanium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of serious adverse events related to the system or implant procedure
Time Frame: 36 months post-implant
Serious adverse events related to the system or implant procedure through 36 months post-implant
36 months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of heart failure hospitalizations
Time Frame: 36 months post-implant
Number of heart failure hospitalizations through 36 months post-implant
36 months post-implant
Duration of heart failure hospitalizations
Time Frame: 36 months post-implant
Duration of heart failure hospitalizations through 36 months post-implant
36 months post-implant
Change NYHA Classification
Time Frame: 36 months post-implant
Changes in NYHA Classification through 36 months post-implant
36 months post-implant
Change in NT-proBNP
Time Frame: 36 months post-implant
Changes in NT-proBNP through 36 months post-implant
36 months post-implant
Change in LVEF
Time Frame: 36 months post-implant
Changes in LVEF through 36 months post-implant
36 months post-implant
Change in Six Minute Hall Walk
Time Frame: 36 months post-implant
Changes in Six Minute Hall Walk distance through 36 months post-implant
36 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CVRx, Inc.

Investigators

  • Study Chair: Thomas Deering, Piedmont Heart Institute
  • Study Chair: Bradley Knight, Northwestern Medicine
  • Study Chair: Larry Chinitz, NYU Heart Rhythm Center
  • Study Chair: Michael Gold, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2020

Primary Completion (Anticipated)

June 1, 2028

Study Completion (Anticipated)

June 1, 2028

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 21, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 360059-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Barostim™ System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe