Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)

Description

Early Feasibility Study of the NORM™ System in Heart Failure Patients

Conditions

Heart Failure

Study Overview

Study Details

Study overview

Early Feasibility Study of the NORM™ System in Heart Failure Patients

Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)

Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center/ New York Presbyterian Hospital, New York, New York, United States, 10032

Rochester

Rochester General Hospital, Rochester, New York, United States, 14621

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Austin

Austin Heart Central at the Heart Hospital of Austin, Austin, Texas, United States, 78756

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Significant comorbidity that, in the investigator's opinion, would results in the patient being unable to safely undergo the procedure or participate in the clinical investigation.
  • * Patients with an estimated Glomerular Filtration Rate (eGFR) \< 25 ml/min/1.73m2
  • * Patients with an in vivo IVC filter, abnormal IVC or femoral venous anatomy or known congenital malformation or absence of IVC or occlusive or free-floating thrombus in the IVC.
  • * Patients who have severe right sided valvular disease or a right sided mechanical valve.
  • * Patients with a cardiac resynchronization therapy device implanted ≤ 3 months to prior to screening.
  • * Patients who have undergone invasive cardiac surgery in the 3 months prior to screening.
  • * Patients who have undergone percutaneous valve / structural heart intervention in in the 3 months prior to screening.
  • * Patients who have received heart transplant or a ventricular assist device or planned for advanced therapies within the next year.
  • * Patients with conditions associated with occlusion of the IVC, iliac or common femoral veins.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Foundry Innovation & Research 1, Limited (FIRE1),

Annette Kent, STUDY_DIRECTOR, Director Clinical US

Study Record Dates

2026-01