Is NCT07574593 recruiting in Sioux Falls, SD?

Yes, NCT07574593 is currently recruiting participants at its Sioux Falls, SD location. This heart failure clinical trial is actively enrolling qualified participants.

How do I join the heart failure clinical trial in Sioux Falls?

To join this clinical trial in Sioux Falls, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Sioux Falls clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Heart Failure Clinical Trial in Sioux Falls, SD

About This Heart Failure Study in Sioux Falls

This is an international, multi-center, prospective, randomized, open-label blinded endpoint study designed to demonstrate that use of the FIRE1 NORM™ System in the management of New York Heart Association Class II/III HF patients is superior for reducing the combined endpoint of worsening HF events and cardiovascular mortality compared to standard of care treatment. Patients will be randomized in a 1:1 ratio to receive either NORM™ System and guided heart failure management (intervention group) or usual standard of care with guided heart failure management (control group).

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

Who Can Participate

Inclusion Criteria

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.

Patients meeting diagnostic criteria for HF diagnosis for greater than 90 days and are on optimally tolerated medical therapy for at least 30 days, as recommended according to current AHA/ACC/HFSA or ESC HF guidelines with any intolerance or contraindications documented, regardless of ejection fraction, as evidenced by meeting either 3a, 3b OR 3c criterion below:

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 provider for administration of an intravenous diuretic to treat HF AND NT-proBNP ≥1000 pg/mL. For those patients presenting with atrial fibrillation or flutter, NT-proBNP ≥1,600 pg/mL. OR

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 provider for administration of an intravenous diuretic to treat HF AND NT-proBNP ≥ 600 pg/mL. For patients presenting with atrial fibrillation or flutter, NT-pro BNP ≥900 pg/mL. OR

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.

Exclusion Criteria

Presence of advanced end stage HF, suggested by but not limited to:

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 sarcoidosis.

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 days prior to consent.

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 clinical site-specific allergy protocol.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Sioux Falls?

Yes, this clinical trial (NCT07574593) has an active research site in Sioux Falls, SD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure Treatment Options in Sioux Falls, SD

If you're searching for heart failure treatment options in Sioux Falls, SD, this clinical trial (NCT07574593) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Sioux Falls research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure clinical trials near you to find additional studies recruiting in your area.

Heart Failure Clinical Trial in Sioux Falls, SD

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