CompletedNot Applicable

The Aortix CRS Pilot Study

United States21 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 range21 Years

SexALL

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,
✕. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury;

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 range21 Years

SexALL

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,
✕. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury;

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