Ignite Creation Date:
2025-12-18 @ 9:57 AM
Ignite Modification Date:
2025-12-18 @ 9:57 AM
Study NCT ID:
NCT00972114
Status:
None
Last Update Posted:
2009-12-10 00:00:00
First Post:
2009-09-03 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CABG Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Ischemic Cardiomyopathy
Sponsor:
None
Organization:
Study Overview
Official Title:
Coronary Artery Bypass Graft Surgery Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Patients With Ischemic Cardiomyopathy: a Prospective Randomized Controlled Clinical Trial
Status:
None
Status Verified Date:
2009-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase I/II, randomized controlled trial to evaluate the use of CABG combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty for patients with ischemic cardiomyopathy. The study hypothesis is that the combined surgical technique to perform pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty as adjunct to CABG, is safe to patients with severe ischemic heart failure and can improve regional myocardial perfusion contractility, which resulting in improved systolic and diastolic left ventricular function.
The primary object of this study will be to evaluate the safety and efficacy of this novel combined surgical technique. The efficacy will be assessed changes in left ventricular ejection fraction by MRI. The secondary endpoint of the study is to assess the effects of this novel combined surgical technique on cardiac contractile function and functional outcome. The effects will be assessed on the basis of clinical status and imaging rests in 6 month follow-up after enrollment. A maximum of 60 patients between 20 and 70 years will be enrolled in the study. These participants will be randomized to receive CABG, pedicled omentum graft combined CABG, or pedicled omentum graft autologous atrial tissue patch cardiomyoplasty combined CABG. The objective evaluations will be performed at baseline and during 6 months follow-up.
The primary object of this study will be to evaluate the safety and efficacy of this novel combined surgical technique. The efficacy will be assessed changes in left ventricular ejection fraction by MRI. The secondary endpoint of the study is to assess the effects of this novel combined surgical technique on cardiac contractile function and functional outcome. The effects will be assessed on the basis of clinical status and imaging rests in 6 month follow-up after enrollment. A maximum of 60 patients between 20 and 70 years will be enrolled in the study. These participants will be randomized to receive CABG, pedicled omentum graft combined CABG, or pedicled omentum graft autologous atrial tissue patch cardiomyoplasty combined CABG. The objective evaluations will be performed at baseline and during 6 months follow-up.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: