Active — Not RecruitingNot Applicable

CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial

United States343 participantsStarted 2021-06-30

Plain-language summary

Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment Treatment Group: Subjects treated with aBMC using the CardiAMP cell therapy system Sham Control Group: Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)

Who can participate

Age range21 Years – 80 Years

SexALL

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

Inclusion criteria

✓. Male or female 21 to 80 years of age
✓. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
✓. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
✓. Evidence of inducible myocardial ischemia on baseline stress testing
✓. Obstructive coronary disease unsuitable for conventional revascularization
✓. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
✓. Able to complete an exercise tolerance test on the treadmill
✓. Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.

What they're measuring

Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol

Timeframe: Baseline and 6 months visit

Trial details

NCT IDNCT03455725

SponsorBioCardia, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-19

View on ClinicalTrials.gov More Refractory Angina trials