ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-06-19

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05763407

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Principal Investigator

Carolyn Borme

STUDY_DIRECTOR

Director Clinical US

Study Locations (Sites)

Columbia University Irving Medical Center/ New York Presbyterian Hospital

New York, New York, 10032

United States

Rochester General Hospital

Rochester, New York, 14621

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

Austin Heart Central at the Heart Hospital of Austin

Austin, Texas, 78756

United States

Collaborators and Investigators

Sponsor: Foundry Innovation & Research 1, Limited (FIRE1)

Carolyn Borme, STUDY_DIRECTOR, Director Clinical US

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 Registration Dates

Study Start Date2023-06-19

Study Completion Date2027-06

Study Record Updates

Study Start Date2023-06-19

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

Cardiovascular Disease

Additional Relevant MeSH Terms

Heart Failure