None listed
Conditions
Brief summary
The purpose of this research is to investigate a new heart therapy device for the treatment of acute decompensated heart failure (ADHF) with worsening renal function (WRF), to evaluate the device for providing support and recovery during unscheduled hospital admissions. This type of heart failure occurs because the heart is not pumping blood effectively leading to a sudden deteriorating or worsening heart failure, often requiring emergency hospital admission. Typically, a patient presents to hospital in an emergency with congestion and fluid retention, resulting in shortness of breath and lower limb swelling. Diuretics are used to remove fluid and reduce congestion which is only effective in around half of the patients treated. The QHeart TARR heart therapy device is a new treatment aiming to support patients who do not respond in a timely manner to diuretics. The QHeart TARR heart therapy device is a small balloon that is deployed inside the descending aorta, the large blood vessel running from of the heart supplying blood to organs and tissues throughout the body, including the kidneys. The TARR balloon device has shown very promising performance and safety data in pre-clinical studies. The TARR heart therapy device uses a small diameter balloon sized for low risk within the aorta. The device is inserted using a standard interventional procedure in under 30 minutes and can be safely removed at any time during use. The device balloon is inflated which then automatically works with your heart allowing your heart to pump more effectively. The study aims to show the TARR device therapy: 1) Provides a clinically significant improvement in heart performance during treatment, and 2) The TARR device and procedures for its insertion, use, and retrieval are as expected and without any adverse events.
Interventions
The QHeart Transcatheter Aortic Recoil Repair (TARR) implant is a low risk and high performance “pumpless” intra-aortic balloon therapy device for improving cardiac output and or reducing heart pressure loading.
The device will be administered by the interventional cardiologist.
The deployment procedure is likely to be under 30 minutes.
The TARR device use will be sequential according to the following duration of use with Group I recruitment being done first, followed by Group II and Group II
The QHeart Transcatheter Aortic Recoil Repair (TARR) implant is a low risk and high performance “pumpless” intra-aortic balloon therapy device for improving cardiac output and or reducing heart pressure loading. The device will be administered by the interventional cardiologist. The deployment procedure is likely to be under 30 minutes. The TARR device use will be sequential according to the following duration of use with Group I recruitment being done first, followed by Group II and Group III, with an anticipated patient enrolment period of 12 to 18 months. Participants will be enrolled in only one of the treatment groups and will have the same severity of acute decompensated heart failure (ADHF) with worsening renal function (WRF). The three patient groups of the study are as follows: i) Group 1: acute TARR use for up to 6 hours (up to 10 patients). Femoral artery (FA) access must be used for Group 1. A minimum of 5 cases must be completed with positive primary endpoints to progress to Group 2. ii) Group 2: acute TARR use for 24 to 48 hours (up to 10 patients per site). Either femoral or axillary artery access will be used. A minimum of 5 cases must be completed with positive primary endpoints to progress to Group 3. iii) Group 3: acute TARR use for 2 to 4 days up to a maximum of 7 days (up to 10 patients per site). Either femoral or axillary artery access will be used. If no patient improvements in the measured primary and secondary study variables are achieved by 48hr of use, the device should be removed. Where primary safety and efficacy endpoints are achieved after 48hr, consideration for patient need to extend treatment by additional 24 hr to 48 hr can be made. Antibiotics must be administered after 3 days of TARR use. Treatment beyond 96 hr (4 days) may be considered only if additional therapy is estimated to promote patient recovery within an additional 48 hours (total of 6 days). The maximum treatment period is 7 days. The measured primary and secondary study variables will be reviewed after every case by the Study Monitor (CRO Mobius) and the Sponsor. This will include review of the access site response, the duration of use, and any patient benefit or adverse events, identifying any change in risk or newly identified risks, and review of compliance with the protocol and TARR use, and correct recording and reporting of data on the case report forms.
Sponsors
QHeart Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Admitted to the hospital with a primary diagnosis of acute decompensated heart failure, with either heart failure with reduced or preserved ejection fraction. 2A) Worsening renal function (serum creatinine increase by greater than or equal to 0.3 mg/dl [greater than or equal to 27 µmol/L]) despite 24 hours of intravenous diuretic therapy (Increase can be compared to a baseline value taken within 90 days of hospitalization or during hospitalization); OR 2B) Projected need by the treating clinician for continued treatment with IV diuretic agents for more than 48 hours with the goal of significant fluid removal (more than 1L net fluid loss/24h). 3A) Objective measure of congestion (Elevated PCWP [greater than or equal to 20 mmHg] OR Elevated CVP [greater than or equal to 12 mmHg]) obtained via catheter measurement; OR 3B) Diuretic resistance defined as at least ONE of the following: i) Urine output of less than 1.5L over 12h following the last diuretic dose, OR ii) Net fluid loss of less than 1L over the last 24 hours, OR iii) Spot urinary sodium concentration of less than 70 mmol/L 2h following the last diuretic dose or cumulative 6-hour natriuresis of less than 100 mmol following the last diuretic dose, OR iv) Clinically unsatisfactory resolution of congestion. 4) Persistent clinical signs and/or symptoms of congestion despite diuretic therapy (one or more of the following): i) dyspnea at rest or with minimal exertion, ii) paroxysmal nocturnal dyspnea, iii) orthopnea, iv) lower extremity edema (greater than or equal to 2+), v) elevated jugular venous pressure, vi) pulmonary rales, vii) enlarged liver or ascites, viii) pulmonary vascular congestion on chest x-ray. 5) Age equal to or >18 years. 6) Patient has read and signed the informed consent prior to study related procedures. 7) Patient willing and able to comply with all required evaluations and follow-up assessments.
Exclusion criteria
1) ADHF related to acute secondary disease (i.e., infection or terminal illness). 2) Active and ongoing hypotension defined as a systolic blood pressure < 90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) < 60 mmHg lasting more than 30 minutes and/or treatment with high dose inotropes (milrinone greater than or equal to 0.375 mcg/kg/min, dobutamine greater than or equal to 5mcg/kg/min or dopamine greater than or equal to 5mcg/kg/min) and/or treatment with vasopressors to maintain a systolic arterial blood pressure equal to or > 90 mmHg or mean arterial blood pressure equal to or >60 mmHg. 3) Current or previous support with a durable left ventricular assist device (LVAD) at any time or use of an extracorporeal membrane oxygenation (ECMO), percutaneous ventricular assist devices, intra-aortic balloon pump within the last 30 days. 4) Recent myocardial infarction. 5) Echocardiographic evidence of primarily right heart failure. 6) Heart failure due to rejection of a previous heart transplant, or planned heart transplantation. 7) Reanimated cardiac arrest in the last 30 days. 8) Suspected or known amyloid disease or other restrictive cardiomyopathy. 9) Severe bleeding risk precluding anticoagulation: i) Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for duration of device use, ii) Gastrointestinal (GI) bleeding within 1 month requiring hospitalization and/or transfusion, iii) Recent major surgery within 1 month if the surgical wound is judged to be associated with an increased risk of bleeding, iv) Platelet count of less than 50,000 cells/mm3, v) Uncorrectable bleeding diathesis or coagulopathy. 10) Contraindicated anatomy: i) Descending aortic anatomy that would prevent safe placement of the device (less than 18 mm or more than 28mm thoracoabdominal aorta diameter at TARR IAB deployment location), ii) Abnormalities of the vessels used for TARR placement and use: the descending aorta, including iliac or femoral arteries in the case of femoral access, the descending aorta including axillary and left subclavian arteries in the case of axillary access, where their condition would prevent safe device placement due to abnormalities of aneurysms, significant tortuosity, or calcifications, femoral artery diameters below 7 mm, left axillary artery diameters below 6 mm, iii) Femoral artery or axillary artery anatomy of severe obstructive calcification or severe tortuosity that would preclude safe placement of a 9Fr to 10F introducer, iv) Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury, v) Prior endovascular surgery or percutaneous intervention involving the thoracoabdominal aorta or history of aortic dissection. 11) Severe aortic stenosis. 12) Known or suspected contrast induced nephropathy. 13) Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication. 14) Absolute contraindications or allergy to unfractionated heparin (e.g., heparin-induced thrombocytopenia) or device materials (e.g. HDPE, PTFE, Pellethane) that cannot be adequately treated with pre-medication. 15) Known hematologic diseases such as leukemia, any coagulopathy or hypercoagulable state, sickle cell anemia or thalassemia. 16) Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: i) Liver disease (cirrhosis of the liver [Child-Pugh class B or C]) or shock liver, ii) History of severe chronic obstructive pulmonary disease (COPD), defined by FEV1/FVC less than 0.7, and FEV1 less than 50% predicted, iii) Prior kidney transplant, isolated single kidney, stage V Chronic Kidney Disease (eGFR greater than or equal to 15) at admission OR use of dialysis, continuous renal replacement therapy (CRRT) or aquapheresis (ultrafiltration) in last 90 days. 17) Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation. 18) Active infection not controlled with antibiotic therapy. 19) Suspected or known pregnancy. Women of child-bearing age must have a negative pregnancy test. 20) Body mass index (BMI) over 40 kg/m2. 21) Unable or unwilling to undergo screening, device implant and retrieval procedures, and 30-day follow-up. 22) Currently participating in an investigational drug or another device study that may influence the data collected for this study. Observational studies are not considered an exclusion. 23) Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject ability to give written informed consent and/or to comply with study procedures. 24) Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments.
Outcome results
None listed