CompletedNot Applicable

The Aortix CRS Pilot Study

United States, Australia21 participantsStarted 2021-02-05

Plain-language 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

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. dyspnea at rest or with minimal exertion,
. paroxysmal nocturnal dyspnea,
. orthopnea,
. lower extremity edema (≥2+),
. elevated jugular venous pressure,
. pulmonary rales,
. enlarged liver or ascites,
. pulmonary vascular congestion on chest x-ray;

Exclusion criteria

. Descending aortic anatomy that would prevent safe placement of the device \[\<18mm or \>31mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\],
. Abnormalities of the aorta or iliac arteries that would prevent safe device placement, including aneurysms, significant tortuosity, or calcifications,
. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath including severe obstructive calcification or severe tortuosity,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serious Adverse Events

Timeframe: 30 days

Serious Procedure Related Adverse Events

Timeframe: 30 days

Device Performance

Timeframe: 7 days

Device Performance

Timeframe: 30 days

Effectiveness

Timeframe: 7 days

Urine Output

Timeframe: 7 day period starting from implant

NT-pro-BNP (Brain Natriuretic Peptide)

Timeframe: 7 days

Trial details

NCT IDNCT04145635

SponsorProcyrion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-07

Results submitted2023-10-20

View on ClinicalTrials.gov More Heart Failure; With Decompensation trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. dyspnea at rest or with minimal exertion,
. paroxysmal nocturnal dyspnea,
. orthopnea,
. lower extremity edema (≥2+),
. elevated jugular venous pressure,
. pulmonary rales,
. enlarged liver or ascites,
. pulmonary vascular congestion on chest x-ray;

Exclusion criteria

. Descending aortic anatomy that would prevent safe placement of the device \[\<18mm or \>31mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\],
. Abnormalities of the aorta or iliac arteries that would prevent safe device placement, including aneurysms, significant tortuosity, or calcifications,
. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath including severe obstructive calcification or severe tortuosity,

What they're measuring

Serious Adverse Events

Timeframe: 30 days

Serious Procedure Related Adverse Events

Timeframe: 30 days

Device Performance

Timeframe: 7 days

Device Performance

Timeframe: 30 days

Effectiveness

Timeframe: 7 days

Urine Output

Timeframe: 7 day period starting from implant

NT-pro-BNP (Brain Natriuretic Peptide)

Timeframe: 7 days