CTRI/2017/07/009008
Active, not recruiting
Phase 2
A prospective, multi-center, single-arm clinical study to evaluate safety and performance of the Dafodil Pericardial Bioprosthesis in patients who require replacement of their natural or prosthetic aortic or mitral valve. - Dafodilâ?¢ â?? 1
Meril Life Sciences Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: I080- Rheumatic disorders of both mitraland aortic valves
- Sponsor
- Meril Life Sciences Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria for Aortic Valve:
- •1\. Patient must be 18 years or older.
- •2\. Patient must provide written informed consent prior to study procedures.
- •3\. STS scores should be less than 4 percent (Low Risk)
- •4\. Patient must agree to attend all follow\-up assessments for up to 5 years and is willing to comply with specified follow\-up evaluations at clinical investigational sites that are participating in the Dafodil\-1 study.
- •5\. Diagnosed with aortic disease requiring valve replacement based on pre\-operative evaluation (Medical history, physical examination, echocardiography and CBC).
- •6\.Patient has significant Aortic stenosis or Aortic regurgitation or patient is subjected for Aortic Valve replacement due to combine aortic lesion (stenosis and regurgitation).
- •(Reference: European society of Cardiology (ESC)/ American Society of Echocardiography (ASE) Guidelines \- 2017\)
- •7\. Scheduled to undergo planned aortic valve replacement with or without concomitant bypass surgery or other valvular surgeries.
- •Inclusion Criteria for Mitral Valve:
Exclusion Criteria
- •Exclusion Criteria for Aortic Valve:
- •A subject meeting any of the following criteria shall be excluded.
- •1\. Has active endocarditis / myocarditis or endocarditis / myocarditis within 3 months to the scheduled aortic replacement surgery.
- •2\. Has renal insufficiency as determined by creatinine (S\-Cr) level greater than or equal to 2\.5 gram per deciliter or end\-stage renal disease requiring chronic dialysis at screening visit.
- •3\. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or TIA within 6 months (180 days) prior to planned valve surgery.
- •4\. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery.
- •5\. Has presence of non\-cardiac disease limiting life expectancy to less than 5 years.
- •6\. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
- •7\. Diagnosed with abnormal calcium metabolism and hyperparathyroidism.
- •8\. Exhibits left ventricular ejection fraction less than or equal to 20 percent as validated by diagnostic procedure prior to planned valve surgery.
Outcomes
Primary Outcomes
Not specified
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