Pivotal Trial of Doraya Catheter in HF Planned After Success in Feasibility Trial

Following successful results from the DORAYA-HF feasibility study, the Doraya catheter is primed to enter a pivotal trial in hospitalized patients with heart failure.1

These data were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix, Arizona, by Ulrich Jorde, MD, a professor in the department of medicine at Albert Einstein College of Medicine and Montefiore Einstein.1

“Hopefully, Doraya will enable clinically meaningful decongestion, accelerate the process, reduce lengths of stay, and then discharge the patient in a fully decongested state,” Jorde told HCPLive in an exclusive interview. “All of that, of course, is right now only in registries, in open-label studies with no control group. But we’re getting ready to refine the exact parameters for the trial, which I anticipate will start in early 2027.”

Patients hospitalized for heart failure typically exhibit volume overload, with roughly 1 in 3 dealing with inadequate diuretic response. Doraya is an implantable catheter deployed percutaneously in the inferior vena cava below the renal veins. The distal frame opening is adjusted to partially obstruct the venous flow, reducing cardiac preload and congestion. This, in turn, triggers a series of hemodynamic effects that begin with unloading the renal venous system, taking pressure off the renal veins and kidneys.2,3

DORAYA-HF was conducted across 14 locations and enrolled patients with a primary diagnosis of acute decompensated heart failure (ADHF), NT-proBNP ≥1000 pg/m, evidence of fluid overload, and insufficient response to intravenous diuretic therapy. Patients with systolic blood pressure <90 mmHg, acute myocardial infarction or acute coronary syndrome within 14 days, or complex congenital heart disease, among other criteria, were excluded from the trial.4

Patients were treated with either diuretics alone or the Doraya catheter with diuretics. The device was placed transfemorally in the IVC for ≤12 hours. The primary outcome was the change in urine output over 24 hours, while the primary safety endpoint was the incidence of device- or procedure-related serious adverse events within 30 days.2

The study ultimately enrolled 16 patients between 2022 and 2024, who were treated at 6 US sites. Mean age was 68 +/- 12 years, and 63% of patients were male. Mean left ventricular ejection fraction was 39 +/- 16%, and eGFR was 41 +/- 18 mL/min/1.73m2. The Doraya catheter was successfully implanted in all 16 patients; the investigators recorded no device-related adverse events and 1 procedure-related adverse event.2

Of the patients given the device, 3 required hospital readmission due to worsening heart failure out to 60 days. Urine output increased from 80 mL/hour at baseline to 224.1 mL/hour during device dwell (P <.01) and remained elevated at 24 hours, where it reached 153.2 mL/hour (P <.01). Central venous pressure and pulmonary capillary wedge pressure both decreased substantially, while urine sodium, dyspnea, jugular venous pressure, and edema grade all improved (P <.05).2

Ultimately, the investigators determined that the Doraya device demonstrated safety and efficacy in this patient population, with no device-related adverse events. The improvements noted in urine output, hemodynamics, and congestion symptoms supported ongoing research, which is expected to culminate with the pivotal trial planned for early 2027.2

“The pivotal trial is obviously a big step for patients, but also for the company to see where this is going in the spectrum of device therapy for cardiorenal syndrome,” Jorde said. “There are multiple devices at this moment, but I feel that this is probably the one that is the least invasive, possibly the safest, and we’ll see whether it’s also very efficacious.”

Editors’ Note: Jorde reports a relevant disclosure with Abbott.

References

1. Jorde U. Trial Tinder Trial #2: DORAYA-HF Pivotal Trial. Presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, Phoenix, AZ. October 9-12, 2026.

2. Klein L, Chung E, Cheng R, et al. Results of the early feasibility study of renal venous afterload modulation with the Doraya device in acute decompensated heart failure patients. Journal of Cardiac Failure. 2026;32(1):202. doi:10.1016/j.cardfail.2025.11.074

3. Zymliński R, Dierckx R, Biegus J, Vanderheyden M, Bartunek J, Ponikowski P. Novel IVC Doraya Catheter Provides Congestion Relief in Patients With Acute Heart Failure. JACC Basic Transl Sci. 2022;7(3):326-327. Published 2022 Apr 4. doi:10.1016/j.jacbts.2022.02.013

4. Revamp Medical Inc. DORAYA-HF Early Feasibility Study. ClinicalTrials.gov Identifier: NCT05206422. Updated August 13, 2026. Accessed October 10, 2026. https://clinicaltrials.gov/study/NCT05206422?term=NCT05206422&rank=1