Doraya Catheter for Heart Failure
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Revamp Medical Inc.
Must not be taking: High dose inotropes
Disqualifiers: Low blood pressure, Recent heart attack, Severe renal dysfunction, Advanced liver disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing the Doraya Catheter, a device that helps manage fluid levels, in heart failure patients who do not respond well to typical treatments. The catheter works by controlling and managing excess fluid in the body.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that participants should not have been treated with high-dose IV inotropes (medications that help the heart pump more effectively) within 2 days prior to enrollment.
What data supports the effectiveness of the Doraya Catheter treatment for heart failure?
The research suggests that device-based therapies, like the Doraya Catheter, offer promise for improving symptoms and prognosis in heart failure patients, as they can address structural heart issues that drugs alone cannot. Similar devices have shown potential in relieving symptoms and improving outcomes in heart failure.
12345How is the Doraya Catheter treatment for heart failure different from other treatments?
The Doraya Catheter is unique because it is a specialized device used to manage heart failure by potentially improving blood flow dynamics, unlike traditional drug therapies that primarily focus on altering heart function or fluid balance.
678910Eligibility Criteria
This trial is for hospitalized patients with acute decompensated heart failure (ADHF) who aren't responding well to IV diuretics. They must have fluid overload and high levels of certain heart-related biomarkers. It's not for those with very low blood pressure, recent heart attacks or interventions, complex congenital heart disease, severe valve disorders, active infections, or critical damage in multiple body systems.Inclusion Criteria
I am in the hospital because of acute heart failure.
IV diuretics do not work well for me.
You have signs of having too much fluid in your body.
+1 more
Exclusion Criteria
Your blood pressure is too low (less than 90 mmHg) when checked at the screening.
I have a severe heart valve problem or need surgery for it.
I have a serious heart condition like myocarditis or cardiomyopathy.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the Doraya Catheter with diuretics or diuretics only
24 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
30 days
Participant Groups
The DORAYA-HF study is testing the Doraya Catheter's ability to manage fluid overload in ADHF patients who don't respond adequately to standard diuretic therapy. The goal is to assess how feasible and safe this catheter is when used in a real-world clinical setting.
2Treatment groups
Experimental Treatment
Active Control
Group I: Doraya CatheterExperimental Treatment1 Intervention
Doraya Catheter with diuretics
Group II: Control ArmActive Control1 Intervention
Diuretics only
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UnityPoint HealthDavenport, IA
The MetroHealth SystemCleveland, OH
The Ohio State UniversityColumbus, OH
UCSFSan Francisco, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Revamp Medical Inc.Lead Sponsor
References
Early pulmonary artery catheterization is not associated with survival benefits in critically ill patients with cardiac disease: An analysis of the MIMIC-IV database. [2022]Many studies demonstrated no improved survival in patients with pulmonary artery catheter placement. However, no consistent conclusions have been drawn regarding the impact of pulmonary artery catheter in critically ill patients with heart disease. This study aimed to investigate the association of early pulmonary artery catheter use with 28-day mortality in that population.
The new concept of ''interventional heart failure therapy'': part 2--inotropes, valvular disease, pumps, and transplantation. [2010]Recent advances in heart failure therapy include a variety of mechanical and device-based technologies that target structural aspects of heart failure that cannot be treated with drug therapy alone; these newer therapies can collectively be described as interventional heart failure therapy. This article is the second in a 2-part series reviewing interventional heart failure therapy. Interventions included in this discussion include those indicated for the treatment of end-stage refractory heart failure, including interventional medical therapy, interventional treatment of valvular disease, mechanical assist devices, and heart transplantation. Also included is a review of the currently available catheter-based pumps, which are intended to provide temporary support in patients with acute hemodynamic compromise. The use of cellular or stem cell therapy for the treatment of heart failure is an emerging interventional therapy and data supporting its use for the treatment heart failure will also be presented, as will a discussion of the role of palliative care and self-care in heart failure therapy.
Long-term vasodilator therapy for heart failure: clinical response and its relationship to hemodynamic measurements. [2019]To assess the clinical efficacy of chronic vasodilator therapy for refractory congestive heart failure, the long-term follow-up (mean 13 months, range 3-30 months) was evaluated in 56 patients treated with hydralazine, usually in combination with nitrates. In the first 6 months, 73% improved subjectively and 59% improved by one or two New York Heart Association classifications; early improvement was usually sustained. Mortality was high, 22% at 6 months and 37% at 12 months, but was significantly lower in patients who had a clinical response to vasodilators (21% in responders vs 55% in nonresponders at 1 year). The only clinical indicator that differentiated responders from nonresponders was the presence or absence of symptomatic progression before initiation of vasodilator therapy. Pulmonary artery pressure, pulmonary capillary wedge (PCW) pressure and stroke work index (SWI) before and during vasodilator therapy correlated with clinical response and survival. Fifteen of 20 patients with PCW
The Heartpod implantable heart failure therapy system. [2022]Congestive heart failure has been described as the new epidemic, despite advances in drug therapy a 2-year mortality of up to 50% persists. This is despite recent improvements in drug therapy. There are limitations to the current drug treatments and cardiac resynchronization devices. The treatment of diastolic dysfunction can be suboptimal. The Savacor Company developed the Heartpod device to directly measure left atrial pressure in patients with congestive heart failure via an implantable device. The patient can in real time, download their intra-cardiac pressure measurements to a hand-held device. With this information, they can titrate their own treatment in a very precise manner.
Outcome studies with device therapy in patients with heart failure. [2019]Heart failure is a common debilitating condition for which pharmacologic therapy thus far has provided only partial relief. Despite, and sometimes because of, medical therapy, the overall prognosis remains poor, with high rates of sudden death and death from progressive heart failure. Device-based therapies offer considerable promise for relief of symptoms and for improving prognosis. It is clear that implantable defibrillators should be considered for patients with heart failure who have been resuscitated from ventricular fibrillation or sustained ventricular tachycardia. Several large studies currently are investigating the effects of implantable defibrillators on total mortality in patients with major left ventricular systolic dysfunction but without other risk factors for sudden death. Cardiac resynchronization is a promising new therapy that may relieve the symptoms of heart failure in appropriately selected patients resistant to optimal pharmacologic therapy. Two large trials (CARE-HF and COMPANION) currently are investigating the effects of cardiac resynchronization therapy (CRT) on morbidity and mortality. It is important that those involved in these trials enroll patients quickly and minimize device implantation into patients who have not been assigned this therapy (cross-overs). Overenthusiasm for the benefits that doctors believe devices might bring could destroy the future basis for our clinical practice, denying future generations of patients and the doctors themselves access to what they believe to be effective treatments.
[Hemodynamics monitoring: correlations of clinical and invasive methods]. [2012]Cardiac failure is the main in-hospital cause of death in acute myocardial infarction. The present review demonstrates the possibilities and advantages of invasive monitoring. The Swan-Ganz catheter offers the possibility of measuring cardiac pressures, particularly pulmonary wedge pressure, cardiac O2 saturations and cardiac output. The main indications are severe left heart failure, right heart failure, complicated myocardial infarction, severe hypovolemia and vasodilator therapy.
Results of percutaneous catheter valvuloplasty for calcified aortic stenosis in the elderly. [2019]Percutaneous catheter valvuloplasty was performed in 37 patients between 60-88 years of age (mean age 74.5 years): 16 of these patients were in functional class IV, with pulmonary oedema at the time of the procedure. A good haemodynamic result was obtained in 32 patients, but 3 of them had to be operated upon subsequently, because of persistence of their symptoms. Two successfully dilated patients died in the hospital, one of cardiac failure following myocardial dysfunction caused by multiple infarcts which had no relation to the aortic dilatation, the other of neurological complications after dilatation. Thus, the primary success rate was 27/37 (73%). The first 10 patients with good initial results have been followed up for more than 6 months. The functional result has been maintained in 8 cases with moderate myocardial dysfunction (left ventricular ejection fraction 0.41 to 0.7), one with restenosis at Doppler assessment. Two patients with severe myocardial dysfunction (left ventricular ejection fraction 0.22 and 0.25) had recurrent cardiac failure, with valvular restenosis in one case. One of them died at home. Percutaneous aortic valvuloplasty is therefore an effective means of treating calcified aortic stenosis in elderly patients. The benefits of this procedure have been maintained for as long as 6 months provided myocardial dysfunction was moderate. At its present stage of development, the technique allows only partial reduction of the aortic stenosis, which may explain the absence of long-term improvement in patients with severe myocardial disease.
Pulmonary valvuloplasty using Inoue balloon catheter. [2019]We report balloon pulmonary valvuloplasty using the Inoue catheter in three patients with severe valvular pulmonic stenosis. The mean right ventricular systolic pressure and the pulmonary valvular peak to peak systolic gradients decreased from 140 +/- 23 to 40 +/- 26 mmHg (P
A new catheter design for use in patients with critical aortic stenosis. [2019]A new catheter that facilitates catheterization in patients with severe aortic stenosis is described. The catheter design is capable of high-pressure injections for left ventriculography, but it maintains maneuverability and has an end hole for use with a guide wire in traversing tightly stenotic valves. Experience with this catheter in 23 patients confirmed that good-quality ventriculograms are obtained after left ventricular entry. Twenty-two of 23 patients with aortic stenosis were studied entirely with this catheter; in only one case were attempts to cross the valve unsuccessful, both with this and other catheters. In conclusion, this new catheter is recommended for routine use in patients with suspected severe aortic stenosis.
[Transfemoral valvuloplasty in calcified aortic valve stenosis]. [2006]In a 55 year old male patient and a 67 year old woman with calcified aortic valve stenosis, a valvuloplasty was performed via the femoral approach using a large-lumen balloon catheter. The 55 year old patient, who had undergone an aortocoronary bypass operation some years ago, displayed the symptoms of a cardiogenic shock. A surgical intervention would have entailed an additional risk. In the second case, there was a raised risk for the operation in view of a coronary two-vessel disease and with regard to the patient's age. By filling the balloon catheter placed in the aortic valve, the pressure gradient could be reduced from 100 mm Hg to 40 mm Hg, and in the second case from 95 mm Hg to 45 mm Hg. The slight aortic insufficiency which had been previously present in the two cases did not increase appreciably. The symptoms of cardiogenic shock disappeared, and there was a distinct clinical improvement. Valvuloplasty is evidently a possible method of treatment (even if it is palliative) in calcified aortic valve stenosis.