Heart Failure study: IVC Sensor
Official title NORM-HF Pivotal Study
ClinicalTrials.gov ID: NCT07574593
What this study is testing
- What it's testing
- This study is testing whether a new heart monitor works better than usual care. It looks at how well it prevents serious heart problems and death.
- Who it's for
- You may be able to join if you have heart failure that limits your daily activities.
- What's involved
- You would be picked by chance to get the new monitor or usual care. You would also get help managing your heart condition.
- Time commitment
- The study lasts for a set time with regular check-ins to see how you are doing.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults 18 years of age or older.
- Provide informed consent for participation in the clinical study and be willing and able to comply with the required assessments, treatment...
- NYHA functional class II with documented HF decompensation within the previous 12 months resulting in a primary HF hospitalization, HF treatment in a...
- NYHA functional class III with documented HF decompensation within the previous 12 months resulting in a primary HF hospitalization, HF treatment in...
- NYHA functional class III AND NT-proBNP ≥1000 pg/mL. For patients presenting with atrial fibrillation or flutter, NT-proBNP ≥1,600 pg/mL.
You likely can't join if
- Persistent NYHA functional class IV HF (ACC/AHA/ESC).
- Current treatment with intravenous vasopressors or inotropes.
- Received, or are likely to receive in the next 6 months, an advanced therapy (e.g., mechanical circulatory support or cardiac transplant or...
- Receiving end of life HF care.
- Severe right sided valvular disease or a right sided mechanical valve.
- Patients with abdominal circumference of greater than 143 cm (56 inches) at screening.
See the full eligibility criteria
Who can join
- Adults 18 years of age or older.
- Provide informed consent for participation in the clinical study and be willing and able to comply with the required assessments, treatment instructions, and clinical follow-up visits according to the specified schedule.
- NYHA functional class II with documented HF decompensation within the previous 12 months resulting in a primary HF hospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare...
- NYHA functional class III with documented HF decompensation within the previous 12 months resulting in a primary HF hospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare...
- NYHA functional class III AND NT-proBNP ≥1000 pg/mL. For patients presenting with atrial fibrillation or flutter, NT-proBNP ≥1,600 pg/mL.
- Patients must be prescribed a daily dose of loop diuretic of 40mg or more furosemide, or equivalent, for the two weeks prior to screening.
- Patients must be able to have their daily dose of loop diuretic be increased by at least 1.5 times.
- IVC diameter within the landing zone of between 14mm and 28mm.
- Minimum IVC landing zone length of 60 mm.
- Patients have sufficient cellular and/or Wi-Fi Internet coverage at home and can access the internet on a phone or a computer at home.
What rules you out
- Persistent NYHA functional class IV HF (ACC/AHA/ESC).
- Current treatment with intravenous vasopressors or inotropes.
- Received, or are likely to receive in the next 6 months, an advanced therapy (e.g., mechanical circulatory support or cardiac transplant or previously listed for transplant).
- Receiving end of life HF care.
- Severe right sided valvular disease or a right sided mechanical valve.
- Patients with abdominal circumference of greater than 143 cm (56 inches) at screening.
- Patients with an estimated Glomerular Filtration Rate (eGFR) \< 25 mL/min/1.73m2 or receiving ultrafiltration or chronic dialysis.
- Presence of end stage hypertrophic cardiomyopathy, end stage restrictive cardiomyopathy, end stage pericardial constriction, end stage cardiac amyloidosis, or other infiltrative cardiomyopathy such as hemochromatosis or...
- Significant congenital heart disease that would impair ability to implant the IVC sensor or complicate interpretation of the reading (e.g., fontan circulation physiology).
- Major non-heart-failure-related CV event (i.e., unstable angina, Type 1 myocardial infarction (MI), percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent.
- Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P), CRT Defibrillator (CRT-D), Cardiac Contractility Modulation (CCM), or implantable neuromodulation devices used to treat HF symptoms within 90...
- Implanted or planned implantation of a pulmonary artery pressure (PAP) monitor.
- Patients that are pregnant, nursing or planning a pregnancy within 1 year of screening.
- Anticipated life expectancy \< 12 months due to another etiology or severity of HF.
- Any condition that, in the opinion of the Investigator, would not allow for implantation or utilization of IVC sensor.
- Current or anticipated participation in any other clinical study during the duration of this study not pre-approved by the Sponsor.
- Patients with active systemic infection at screening.
- Patients with hypersensitivity or allergy to antiplatelet agents or Sensor components (Nitinol, Polyurethane [PU], Nylon, Polyethylene Terephthalate [PET], and Gold) or contrast media that will not be managed with a...
- Unable to tolerate dual antiplatelet therapy for at least 30 days following implant of the respective sensor or unable to continue oral anticoagulation if currently prescribed.
- Patients with an in vivo IVC filter, abnormal IVC or femoral venous anatomy, known congenital malformation or absence of IVC, or occlusive or free-floating thrombus in the IVC, iliac, or common femoral veins.
- Patients who have procedures planned that require venous femoral access within 3 months of the Sensor implantation.
- Patients with pulmonary embolism, venous thrombosis, or thromboembolism in the 6 months prior to screening and/or with ongoing concerns of hypercoagulability due to underlying conditions e.g., thrombophilia.
The study team makes the final eligibility decision.
Where it is enrolling
- Chula Vista, California, United States
- Sacramento, California, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Baton Rouge, Louisiana, United States
- Boston, Massachusetts, United States
- Kansas City, Missouri, United States
- Omaha, Nebraska, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Colombus, Ohio, United States
- Toledo, Ohio, United States
- Tulsa, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Columbia, South Carolina, United States
- Greenville, South Carolina, United States
- Sioux Falls, South Dakota, United States
- Dallas, Texas, United States
- Plano, Texas, United States
- Round Rock, Texas, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chula Vista, California, United States; Sacramento, California, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Baton Rouge, Louisiana, United States; Boston, Massachusetts, United States and 15 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.