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CTRI Number  CTRI/2026/02/103828 [Registered on: 13/02/2026] Trial Registered Prospectively
Last Modified On: 09/09/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A Prospective Post market Clinical Follow-up Study of Intra-Aortic Balloon Counterpulsation Therapy for Supporting Heart Function. 
Scientific Title of Study   A prospective, observational, single-arm, open-label, multi-center, post-market clinical follow-up study to evaluate the safety and performance of the MYOSIST IAB Catheter. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MLS/MYOSIST IAB Catheter PMCF Study_V 1.0.0_23-Sep- 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kiran Kumar Shetty 
Designation  Additional General Manager– Product Performance Engineering and PMCF 
Affiliation  Meril LIfe Science Pvt. Ltd 
Address  Meril Life Sciences Pvt. Ltd., Survey No. 135/139, Bilakhia House, Muktanand Marg, Chala, Vapi.

Valsad
GUJARAT
396191
India 
Phone  9743700109  
Fax    
Email  kirankumar.shetty@merillife.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kiran Kumar Shetty 
Designation  Additional General Manager– Product Performance Engineering and PMCF 
Affiliation  Meril LIfe Science Pvt. Ltd 
Address  Meril Life Sciences Pvt. Ltd., Survey No. 135/139, Bilakhia House, Muktanand Marg, Chala, Vapi.


GUJARAT
396191
India 
Phone  9743700109  
Fax    
Email  kirankumar.shetty@merillife.com  
 
Details of Contact Person
Public Query  
Name  Dr Kiran Kumar Shetty 
Designation  Additional General Manager– Product Performance Engineering and PMCF 
Affiliation  Meril LIfe Science Pvt. Ltd 
Address  Meril Life Sciences Pvt. Ltd., Survey No. 135/139, Bilakhia House, Muktanand Marg, Chala, Vapi.


GUJARAT
396191
India 
Phone  9743700109  
Fax    
Email  kirankumar.shetty@merillife.com  
 
Source of Monetary or Material Support  
Meril Life Sciences Pvt. Ltd. MI1 Ground Floor, Muktanand Marg, Chala, Vapi, Valsad, Gujarat, 396191, India. 
 
Primary Sponsor  
Name  Meril Life Sciences Pvt. Ltd, 
Address  Survey No. 135/139, Bilakhia House, Muktanand Marg, Chala, Vapi – 396191, Gujarat, India. 
Type of Sponsor  Other [Medical Device] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suresh Kumar Paidi  Anil Neerukonda Hospital  Ground Floor, Department of Cardiology, Anil Neerukonda Hospital, Opposite: Three polamamba temple, Sangivalasa, Tagurapuvalasa, Visakhapatnam 531162, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 		 9866311341

kumar.has.suresh55@gmail.com 
Dr Ajeet Bana  Eternal Hospital, Unit of Eternal Care Centre & Research Institute   ground floor, Unit of Eternal Heart Care Centre & Research Institute Pvt. Ltd., 3A, Jagatpura Road, Near Jawahar Circle, Jaipur-302017 India
Jaipur
RAJASTHAN 		 9829018195

drajeet.bana@eternalheart.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Eternal Heart Care Centre Research Institute Institutional Ethics committee  Approved 
Institutional Ethics Committee NRI Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  98.00 Year(s)
Gender  Both 
Details  1. Participants having refractory unstable angina or AMI,
Impending infarction or refractory ventricular failure or
complication of acute MI or Cardiogenic shock.
2. Participants who require support for diagnostic or
percutaneous revascularization or interventional procedures
or ischemia-related intractable ventricular arrhythmias or
septic shock, or intraoperative pulsatile flow generation.
3. Participants who require weaning from cardiopulmonary
bypass, cardiac support for non-cardiac surgery.
4. Participants who require prophylactic support in preparation
for cardiac surgery, post-surgical myocardial dysfunction
cardiac output syndrome, myocardial contusion, mechanical
bridge to other assist devices, and cardiac support following
correction of anatomical defects.
5. The participants who are willing to be treated with the
MYOSIST Intra-Aortic Balloon Catheter and accessories 
 
ExclusionCriteria 
Details  1. Participants having aortic dissection.
2. Participants having an abdominal or aortic aneurysm.
3. Participants having aortic, iliac, or femoral vasculature with
high tortuosity or calcification.
4. Participants with serious abnormal blood coagulation (based
on clinical practice using INR or ACT).
5. Participants who are unwilling or unsuitable for postoperative
instructions.
6. The participant who is unwilling or unable to sign the
Informed Consent Document. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.Intra-Aortic Balloon Catheter (IABP) radiographic
position rate
2.Major Adverse Cardiac and Cerebrovascular Events
(MACCE)
3.Major Device-Related Adverse Events
 		 1. Time Frame: Intra-operative, through discharge, 1 week, 1 month, 3 months, 6 months, 1 year
2. Time Frame: Through discharge, 1 week, 1 month, 3 months, 6 months, 1 year.
3. Time Frame: Through discharge, 1 week, 1 month, 3 months, 6 months, 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1.All-cause mortality
2.Access-site complications
3.Major procedural complications
4.Hemodynamic Parameters
5. Ease of use
6.Length of Hospital Stay
7.SF-36  		 1.Time Frame: Intra operative,
through discharge, 1 week, 1 month, 3 months
2.Time Frame: Through
discharge, 1 week, 1 month, 3 months
3.Time Frame: Intraoperative
4. Time Frame: Pre-operative,
intra-operative, discharge
5. Time Frame: Intra-operative
6. Time Frame: Admission to
discharge
7.Time Frame: Pre-operative, through discharge, 1
week, 1 month, 3 months 
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   28/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   MYOSIST™ Intra-Aortic Balloon Catheter Kit (8F): A prospective, observational, single-arm, open-label, multi-center, post-market clinical follow-up study to evaluate the safety and performance of the MYOSIST IAB Catheter.

Study Design: A prospective, single-arm, open-label, multi-center, observational, real-world, post-market clinical follow-up.

Objective: To evaluate the safety and performance of MYOSIST™ IAB Catheter.

Indication: The Intra-Aortic Balloon Catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby the balloon inflates during diastole and deflates during systole, increases blood supply to the heart muscle and decreases the work of the left ventricle.
The MYOSIST™ Intra-Aortic Balloon Catheter has the following
indications for use:
 Refractory Unstable Angina.
 Acute Myocardial Infarction (AMI).
 Impending Infarction.
 Refractory Ventricular Failure.
 Complications of Acute MI
 Cardiogenic Shock.
 Support for diagnostic, percutaneous revascularization, and interventional procedures.
Ischemia-related intractable ventricular arrhythmias.
 Septic Shock.
 Intraoperative pulsatile flow generation.
 Weaning from cardiopulmonary bypass.
 Cardiac support for non-cardiac surgery.
 Prophylactic support in preparation for cardiac surgery.
 Post-surgical myocardial dysfunction/low cardiac output syndrome.
 Myocardial Contusion.
 Mechanical bridge to other assist devices.
 Cardiac support following correction of anatomical defects.

Rationale of the Study
The intra aortic balloon catheter (IABC) is a well-established mechanical circulatory support device designed to enhance coronary perfusion and reduce myocardial oxygen demand in Participants with compromised cardiac function. Despite its long-standing use, the clinical utility
of IABC remains debated, particularly in settings such as cardiogenic shock, high-risk PCI, and persistent ischemia following acute myocardial infarction. IABP features an easy implantation technique and can be rapidly deployed bedside under transthoracic or transesophageal echocardiographic guidance. This avoids the need for Participant transfer to the CathLab with the inherent risk of destabilization, and makes it an attractive approach in case of unstable hemodynamics [2]. Recent studies have produced mixed results regarding its impact on survival
and clinical outcomes, warranting further study. Despite certain advancements in technique and Participant selection, there is a need to reassess the performance and safety of IABC use in realworld clinical practice. This study aims to evaluate the hemodynamic benefits, procedural safety,
and impact on short- and long-term outcomes in Participants undergoing IABC support. Hence, the present study aims to evaluate the safety and performance of the MYOSIST™ IAB Catheter.
 
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