Study of Dafodil Pericardial Bioprosthesis in patients who require replacement of their natural or artificial heart valve for evaluation of its safety and performance.
Scientific Title of Study
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.
Department of Cardiothoracic Surgery, Ansari Nagar, New Delhi, Delhi 110029, India New Delhi
9811763740
shivchoudhary@hotmail.com
Dr Nityanand Thakur
Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals
Department of Cardiothoracic Surgery, Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Jai Prakash Narayan Road, Near Pune Railway Station, Pune, Maharashtra – 411001, India Pune
9822830642
nityanandt@hotmail.com
Dr Dhaval Naik
Care Institute of Medical Sciences (CIMS)
Department of Cardiothoracic and Vascular Surgery, Opposite Panchamrut Bunglows, Near Shukan Mall, Off Science City Road, Sola, Ahmedabad-380060, Gujarat, India Ahmadabad
9099111133
dhaval.naik@cims.me
Dr Manish Porwal
CHL Hospitals
Department of Cardiothoracic Surgery, A.B. Road, Near L.I.G Square,
Indore, Madhya Pradesh 452008, India
Indore
9827055997
mporwal@hotmail.com
Dr Anurag Garg
Dr. D. Y. Patil Medical College, Hospital and Research Centre
Department of Cardiovascular & Thoracic Surgery, Dr. D. Y. Patil Medical College, Hospital and Research Centre,
Pimpri, Sant Tukaram Nagar,
Pune-411018, Maharashtra, India
Pune
9921999321
gargjunior@hotmail.com
Dr Vijay Gupta
Dr. Ram Manohar Lohia Hospital
Department of Cardiovascular Thoracic Surgery, Baba Kharak Singh Marg, New Delhi-110001, India New Delhi
Fortis Escorts Heart Institute and Research Centre
Department of Cardiovascular Surgery, Fortis Escorts Heart Institute and Research Centre Okhla Road, Opposite Holy Family Hospital, New Delhi-110025, Delhi, India New Delhi
9810149301
zile.meharwal@fortishealthcare.com
Dr P Chandrasekar
G Kuppuswamy Naidu Memorial Hospital
Department of Cardiothoracic Surgery, A-Block-2nd floor, G Kuppuswamy Naidu Memorial Hospital, Pappanaicken Palayam, Coimbatore, Tamil Nadu- 641037, India Coimbatore
9443047152
chanpad@gmail.com
Dr Prashant Vaijayanath
Kovai Medical Center and Hospital Limited
Department of Cardiothoracic and Vascular Surgery, 99, Avanashi Road, Coimbatore-641014, India Coimbatore
0422-4324530
vaijyanath3@gmail.com
Dr Devi Prasad Shetty
Narayana Health
Department of Cardiac Surgery, 258/A, Anekal Taluk, Hosur Road, Bommasandra Industrial Area, Bengaluru, Karnataka 560099 Bangalore
8027835333
devishetty@nhhospitals.org
Dr Atul Maslekar
Narayana Multispeciality Hospital
Department of Cardiothoracic and Vascular Surgery, Nr. Chakudiya Mahadev, Rakhial Cross Road, Opp. Rakhial Police Station, Rakhial, Ahmedabad-380023, Gujarat, India Ahmadabad
9723817370
atulmaslekar@hotmail.com
Dr Anand Sancheti
NewEra Hospital And Research Institute
Department of Cardiothoracic and Vascular Surgery, Lakadganj, Nagpur, Maharashtra 440008, India Nagpur
9325544778
dranandsancheti@gmail.com
Dr Binay Krishna Sarkar
NRS Medical College and Hospital
Department of Cardiovascular and Thoracic Surgery, NRS Medical College and Hospital, 138 AJC Bose Road, Kokalta-700014 Kolkata
9674700136
binayskr@hotmail.com
Dr S S Rajput
Ram Manohar Lohia Institute of Medical Sciences
Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomati Nagar, Lucknow - 226010 Lucknow
8176007067
drssrajput60@gmail.com
Dr Nirmal Gupta
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Department of Cardiothoracic and Vascular Surgery, Raebareli Road, Lucknow-226014, India Lucknow
9415024422
drnirmalgupta@gmail.com
Dr Seetharama Bhta
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Department of Cardiothoracic surgery, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bannerghatta Main Road, Jayanagara 9th Block, Bengaluru, Karnataka 560069, India Bangalore
08022977395
pssbhat@gmail.com
Dr C S Hiremath
Sri Sathya Sai Institution of Higher Medical Sciences
Department of Cardiothoracic and Vascular Surgery, Whitefield, Bangalore-560066, Karnataka, India Bangalore
9481119696
cs.hiremath_18@yahoo.co.in
Dr S Rajan
The Madras Medical Mission
Department of Cardiothoracic and Vascular Surgery, 4-A, Dr. J. Jayalalitha Nagar, Mogappair,Chennai - 600 037, Tamil Nadu, India
Chennai
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:
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 mitral valve disease requiring valve replacement based on pre-operative evaluation (Medical history, physical examination, echocardiography and CBC).
6. Patient has significant Mitral Stenosis or Mitral Regurgitation or patient is subjected for Mitral Valve replacement due to combine mitral lesion (stenosis and regurgitation).
(Reference: European society of Cardiology (ESC)/ American Society of Echocardiography (ASE) Guidelines - 2017)
7. Scheduled to undergo planned mitral valve replacement with or without concomitant bypass surgery or other valvular surgeries.
ExclusionCriteria
Details
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.
9. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation.
10. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery.
11. Documented leukopenia (WBC less than 3.5 x 10³ per microlitre), acute anemia (Hgb less than 10.0 grams per deciliter or 6 milimoles per litre) or thrombocytopenia (platelet count less than 50 x 10³ per microlitre) accompanied by history of bleeding diathesis and coagulopathy.
12. Has prior organ transplant or is currently an organ transplant candidate.
13. The patient is currently participating in a study of an investigational drug or device.
14. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in study.
15. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant material.
16. Requires concomitant left ventricular assist device (LVAD) placement.
17. Currently unable to give voluntary informed consent
18. A known hypersensitivity or contraindication to bivalirudin, nitinol, prasugrel, heparin, clopidogrel, acetyl salicylic acid, or contrast material.
Exclusion Criteria for Mitral 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 mitral valve 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.
9. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation.
10. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery.
11. Documented leukopenia (WBC less than 3.5 x 10³ per microlitre), acute anemia (Hgb less than 10.0 gram per deciliter or 6 milimoles per litre) or thrombocytopenia (platelet count less than 50 x 10³ per microlitre) accompanied by history of bleeding diathesis and coagulopathy.
12. Has prior organ transplant or is currently an organ transplant candidate.
13. The patient is currently participating in a study of an investigational drug or device.
14. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in study.
15. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant material.
16. Requires concomitant left ventricular assist device (LVAD) placement.
17. Currently unable to give voluntary informed consent.
18. A known hypersensitivity or contraindication to bivalirudin, nitinol, prasugrel, heparin, clopidogrel, acetyl salicylic acid, or contrast material.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
MACE, Cardiovascular mortality, Stroke and Transient Ischemic Attack (TIA), Major bleeding, Minor bleeding, Acute kidney injury(AKIN classification), Valve thrombosis, Structural valve deterioration, Prosthetic valve Endocarditis, Major paravalvular leak, Conduction disturbances and arrhythmias, Nonstructural valve dysfunction, Mitral valve apparatus damage or dysfunction, Aortic valve apparatus damage or dysfunction, Explant, Hemolysis, Trial valve-related reoperation
Baseline, 1 month, 6 months, 1 year, 2 years,3 years,4 years and 5 years
Secondary Outcome
Outcome
TimePoints
NYHA, Quality of life, Hemodynamic performance, Device success
Baseline, 1 month, 6 months, 1 year, 2 years,3 years,4 years ,and 5 years
Target Sample Size
Total Sample Size="60" Sample Size from India="60"
This is a prospective, multi-center, single-arm clinical study to evaluate safety and performance of the Dafodil Pericardial Bioprosthesis for the replacement of natural or prosthetic aortic or mitral valve in approximately 60 patients (30 patients will be
enrolled in prosthetic aortic valve and 30 patients will be enrolled in mitral valve replacement procedure) in India at more than 5 sites.
The main objective of the study is to evaluate safety and performance of the Dafodil Pericardial Bioprosthesis in high risk, symptomatic patients with severe aortic stenosis at different time points [Baseline, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years].
All eligible subjects based on inclusion/exclusion will be approached to sign Informed Consent Form approved by respective Ethics Committee before starting the study related process. Subjects will be kept treated with Dafodil Pericardial Bioprosthesis in patients who require replacement of their natural or prosthetic aortic or mitral valve as per standard guidelines and practices. The subject will be kept on a standard regimen in post operative and follow-up period. Subject’s clinical follow-up will be taken at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
