The Aortix CRS Pilot Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04145635 |
Recruitment Status :
Completed
First Posted : October 30, 2019
Results First Posted : April 17, 2024
Last Update Posted : April 17, 2024
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | October 25, 2019 | ||||||||
First Posted Date ICMJE | October 30, 2019 | ||||||||
Results First Submitted Date ICMJE | October 20, 2023 | ||||||||
Results First Posted Date ICMJE | April 17, 2024 | ||||||||
Last Update Posted Date | April 17, 2024 | ||||||||
Actual Study Start Date ICMJE | February 5, 2021 | ||||||||
Actual Primary Completion Date | October 7, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||
Original Primary Outcome Measures ICMJE |
|
||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE |
|
||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | The Aortix CRS Pilot Study | ||||||||
Official Title ICMJE | An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients With Cardiorenal Syndrome | ||||||||
Brief Summary | The Aortix CRS Pilot Study: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome | ||||||||
Detailed Description | The study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and performance of the Aortix System in patients hospitalized with acute decompensated heart failure (ADHF) and worsening renal function refractory to medical management with persistent congestion. The Aortix system consists of the Aortix Delivery System, Introducer Set, the Aortix Pump, the Aortix Control System, and the Aortix Retrieval System. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
Condition ICMJE |
|
||||||||
Intervention ICMJE | Device: Aortix System
Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) with worsening renal function.
|
||||||||
Study Arms ICMJE | Experimental: Aortix Device
Aortix Pump, Aortix Delivery System, Introducer Set, Aortix Control System, Aortix Retrieval System
Intervention: Device: Aortix System
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Actual Enrollment ICMJE |
21 | ||||||||
Original Estimated Enrollment ICMJE |
45 | ||||||||
Actual Study Completion Date ICMJE | March 9, 2023 | ||||||||
Actual Primary Completion Date | October 7, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: 1) Admitted to the hospital with a primary diagnosis of acute decompensated heart failure, either heart failure with reduced or preserved ejection fraction (HFrEF, HFpEF or HFmEF); 2) Worsening renal function (serum creatinine increase by ≥0.3 mg/dl [≥27 μmol/L]) despite 48 hours of intravenous diuretic therapy Increase can be compared to a baseline value taken within 90 days of hospitalization or during hospitalization; 3) Objective measure of congestion (Elevated PCWP [≥20 mmHg] OR Elevated CVP [≥12 mmHg]) obtained via catheter measurement; 4) Persistent clinical signs and/or symptoms of congestion despite diuretic therapy (one or more of the following):
a) 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 7 days, b) GI bleeding within 6 months requiring hospitalization and/or transfusion, c) Recent major surgery within 6 months if the surgical wound is judged to be associated with an increased risk of bleeding, d) Endovascular procedure with ilio-femoral access > 6 FR within 30 days, e) Platelet count <75,000 cells/mm3, f) Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy); 18) Current endovascular stent graft in the descending aorta or any femoro-iliac vessels; 19) Contraindicated Anatomy:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 21 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Listed Location Countries ICMJE | Australia, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04145635 | ||||||||
Other Study ID Numbers ICMJE | PVP017 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE |
|
||||||||
Current Responsible Party | Procyrion | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Procyrion | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Procyrion Australia Pty Ltd | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Procyrion | ||||||||
Verification Date | April 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |