Is NCT06174103 recruiting in Durham, NC?

Yes, NCT06174103 is currently recruiting participants at its Durham, NC location. This heart failure clinical trial is actively enrolling qualified participants.

How do I join the heart failure clinical trial in Durham?

To join this clinical trial in Durham, 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 Durham 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 Durham, NC

About This Heart Failure Study in Durham

The purpose of this study is to assess the feasibility of using the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life. The BiVACOR TAH System is intended for use as a bridge to transplant (BTT). Feasibility will be assessed by evaluating safety and performance of the BiVACOR TAH System in study subjects.

Sponsor: BiVACOR Inc.

Who Can Participate

Inclusion Criteria

Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the International Society of Heart and Lung Transplantation (ISHLT) guidelines or has univentricular heart failure in which LVAD support is not recommended. ISHLT Guidelines for Biventricular Support:

Biventricular failure with at least two of the following hemodynamic and/or echocardiographic measurements.

Right ventricular ejection fraction (RVEF) ≤ 30%

Right ventricular stroke work index (RVSWI) ≤ 0.25 g/m/beat/m2

Tricuspid annular plane systolic excursion (TAPSE) ≤ 14 mm

Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio \> 0.72

Central venous pressure (CVP) \> 15mmHg

CVP to pulmonary capillary wedge pressure (PCWP) ratio \> 0.63

Tricuspid insufficiency grade 4

Pulmonary artery pressure index (PAPi) \< 2

Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.

Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative heart disease).

Patient is categorized as INTERMACS Patient Profile Classification 2 or 3.

Patient is classified as NYHA Class IV.

Patient has a left ventricular ejection fraction (LVEF) ≤ 25%, with the exception of patients with restrictive or constrictive physiology.

Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 L/min/m2 without inotropes if inotropes are contraindicated (e.g., restrictive or constrictive heart failure), and meets one of the following criteria:

Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond or is not able to tolerate OMM; or

Has advanced heart failure for at least 14 days and is dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support device (MCSD) for at least seven days.

Patient is eligible for cardiac transplantation as determined by the implanting center.

Patient has adequate room in the chest as determined by 3-D imaging or other standard clinical assessments.

Patient has read and understands the informed consent form (ICF) and has voluntarily provided informed consent.

Exclusion Criteria

Patient has contraindications to anticoagulation or antiplatelet therapies.

Patient has coagulopathy defined by a platelet count \< 50 k/µl.

Patient has insufficient space in the chest to accommodate the BiVACOR pump.

Patient has a body mass index (BMI) ≥ 35 kg/m2.

Patient is highly pre-sensitized prior to pump implantation.

Patient is unconscious and unresponsive.

Patient is on pre-implant extracorporeal membrane oxygenation (ECMO) for \> 7 days.

Patient is on pre-implant temporary MCSD for more than 21 days \[e.g., Intra-aortic balloon pump (IABP), Impella, CentriMag, etc.\] unless ambulatory and free from adverse effects associated with the MCSD.

Patient is implanted with durable mechanical circulatory support (LVAD or RVAD).

Patient experienced cerebrovascular accident (CVA) within three months of eligibility evaluation.

Patient has severe end-organ dysfunction as evidenced by:

Total bilirubin \> 4.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy, and/or

Glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 or renal replacement therapy dependence.

Patient has severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease requiring home oxygen.

Patient has primary pulmonary hypertension ≥ 8 Wood units.

Patient has severe systemic light-chain amyloidosis.

Patient has been diagnosed with severe cardiac cachexia or irreversible frailty.

Patient has diabetes with advanced diabetic neuropathy with accompanying skin ulceration.

Patient has a blood-borne infection within seven days of eligibility evaluation. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.

Patient is pregnant or planning pregnancy.

Patient has a co-morbidity or illness that would limit survival to less than two years.

Patient has a current drug and/or alcohol addiction or known substance abuse.

Patient has insufficient social support or a history of non-compliance with medical instructions as determined by the Investigator.

Patient is participating in another clinical trial that may impact or confound the results of the BiVACOR TAH EFS.

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 Durham?

Yes, this clinical trial (NCT06174103) has an active research site in Durham, NC 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 Durham, NC

If you're searching for heart failure treatment options in Durham, NC, this clinical trial (NCT06174103) 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 Durham 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 Durham, NC

Expert Care in Durham

IRB Approved

No-Cost Care

Apply for This Durham Location

Why Participate?

Simple Process