RecruitingNot Applicable

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

United States320 participantsStarted 2023-08-23

Plain-language summary

Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy. Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.

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.

Exclusion criteria

✕. 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,
✕. GI bleeding within 6 months requiring hospitalization and/or transfusion,
✕. Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,
✕. Procedure with arterial ilio-femoral access \> 6 FR within 30 days,
✕. Platelet count \<75,000 cells/mm3,
✕. Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;
✕. Inability to tolerate anticoagulation therapy for up to 7 days.
✕. Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\],

What they're measuring

Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.

Timeframe: Baseline to 30 day Follow-Up

Primary Effectiveness Endpoint: Combined composite of clinically significant reduction in net fluid loss over 7 days and freedom from mortality or heart failure re-hospitalization/therapy escalation from the baseline visit to the 30-day follow-up visit.

Timeframe: Baseline to 30 day Follow-Up

Trial details

NCT IDNCT05677100

SponsorProcyrion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Rubi Reyes-Fuentez

832-536-1601 rubi@procyrion.com

View on ClinicalTrials.gov More Heart Failure trials

Plain-language summary

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.

Exclusion criteria

✕. 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,
✕. GI bleeding within 6 months requiring hospitalization and/or transfusion,
✕. Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,
✕. Procedure with arterial ilio-femoral access \> 6 FR within 30 days,
✕. Platelet count \<75,000 cells/mm3,
✕. Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;
✕. Inability to tolerate anticoagulation therapy for up to 7 days.
✕. Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\],

What they're measuring

Primary Safety Endpoint: Incidence of Aortix Device / Procedural-Related Major Adverse Events (MAE) through 30 days of Follow-up.

Timeframe: Baseline to 30 day Follow-Up