DORAYA-HF Early Feasibility Study

Not Applicable

Recruiting

• Conditions: Acute Decompensated Heart Failure

• Registration Number: NCT05206422
• Lead Sponsor: Revamp Medical Inc.

Brief Summary

The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Study Start: 2022-10-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events	30 days	Device or procedure related SAEs rate (including MACE) based on CEC adjudication.
Urine Output	baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours]	Change in rate of urine output

Trial Locations

Locations (11)

Zuckerberg San Francisco General; 🇺🇸 San Francisco, California, United States

San Francisco VA; 🇺🇸 San Francisco, California, United States

UCSF; 🇺🇸 San Francisco, California, United States

Cleveland Clinic; 🇺🇸 Weston, Florida, United States

Henry Ford; 🇺🇸 Detroit, Michigan, United States

Christian Hospital; 🇺🇸 Saint Louis, Missouri, United States

UMC of Southern Nevada; 🇺🇸 Las Vegas, Nevada, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

The MetroHealth System; 🇺🇸 Cleveland, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

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