First In Human Study of the Doraya Catheter for the Treatment of AHF Patients

• ClinicalTrials.gov Identifier: NCT03234647
• Recruitment Status: Completed
• First Posted: July 31, 2017
• Last Update Posted: May 6, 2021
• Sponsor: Revamp Medical Ltd.
• Information provided by (Responsible Party): Revamp Medical Ltd.

Tracking Information

• First Submitted Date: July 19, 2017
• First Posted Date: July 31, 2017
• Last Update Posted Date: May 6, 2021
• Actual Study Start Date: January 1, 2018
• Actual Primary Completion Date: April 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 26, 2017)

Device or procedure related Serious Adverse Event (SAE) rate through 60 days [ Time Frame: 60 days ]

SAE as defined by ISO 14155

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
• Official Title: First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
• Brief Summary: Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.
• Detailed Description: The purpose of this clinical investigation is to evaluate the safety and performance of the Doraya catheter in patients admitted with AHF, presenting persistent volume over load and poor response to diuretic treatment.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Heart Failure

Intervention

Device: Doraya catheter

Temporary deployment of the Doraya catheter in AHF patients.

Study Arms

Experimental: AHF patients

AHF patient treatment with the Doraya catheter

Intervention: Device: Doraya catheter

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 4, 2021): 9
• Original Estimated Enrollment (submitted: July 26, 2017): 15
• Actual Study Completion Date: April 30, 2021
• Actual Primary Completion Date: April 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• AHF subjects with poor diuretic response

Exclusion Criteria:

• AHF subjects with sufficient diuretic response

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Israel, Poland

Administrative Information

• NCT Number: NCT03234647
• Other Study ID Numbers: Doraya FIH Study for AHF
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Revamp Medical Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Revamp Medical Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tal Hasin, MD; Shaare Zedek Medical Center

• PRS Account: Revamp Medical Ltd.
• Verification Date: September 2018