Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells

NCT02735993 | Withdrawn

• 1 other identifier: CREATE
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This cardiac registry study will collect information from patients with ischemic or non-ischemic heart failure that have been treated with adipose-derived regenerative cells (ADRCs) delivered via intramyocardial injection.

Conditions

Heart Failure; Coronary Artery Disease

Keywords

Celution; ADRC; Heart Failure; Device

Outcome Measures

Primary Outcomes (1)

• Change in the Minnesota Living with Heart Failure Questionnaire.

  6 months

Secondary Outcomes (5)

• Heart Failure Symptoms

  Days 90, 180 and 360

• LVESV/LVEDV

  Day 180

• LVEF assessed by contrast Echocardiography

  Day 180

• Treadmill exercise test

  Day 180

• Angina Symptoms

  Days 90, 180 and 360

Other Outcomes (1)

• MACEs defined as cardiac death, myocardial infarction or hospitalization for heart failure.

  Ongoing evaluation from Day 1 through Month 60

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure due to non-ischemic disease (idiopathic cardiomyopathy) or coronary artery disease (CAD) that can not be revascularized.

You may qualify if:

• Males or females \> 20 and \< 80 years of age
• Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization OR idiopathic dilated cardiomyopathy
• Symptoms of heart failure (e.g. NYHA Stages of Heart Failure Class II or III)
• On maximal medical therapy for heart failure and if present, anginal symptoms
• Hemodynamic stability (SBP ≥ 90 mm/Hg, HR \<110 beats/min)
• Ejection fraction ≤ 45%
• Left ventricular wall thickness \> 5 mm at the target site(s) for cell injection, confirmed by Contrast Echo within 4 weeks prior to enrollment, and free of thrombus

You may not qualify if:

• Vascular anatomy and/or peripheral artery disease that prevents or impedes cardiac catheterization
• Aortic or mitral valve disease where valve replacement is indicated
• Presence of mechanical aortic or mitral valves
• Presence of aortic dissection
• Planned staged treatment of CAD or other therapeutic intervention on the heart within the subsequent 3 months
• TIA or stroke within 30 days prior to the procedure
• ICD placement or ablation therapy within 30 days prior to the procedure
• Acute coronary syndrome (ACS) or a myocardial infarction in the 30 days prior to the procedure
• Revascularization within 30 days prior to intramyocardial injection of ADRCs
• Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline.

Sponsors & Collaborators

• Cytori Therapeutics: lead

MeSH Terms

Conditions

Heart Failure; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Steven Kesten

  Cytori Therapeutics

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 13, 2016
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2020
• Last Updated: April 13, 2016

Record last verified: 2016-04