A Prospective Post market Clinical Follow-up Study of Intra-Aortic Balloon Counterpulsation Therapy for Supporting Heart Function.

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. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/02/103828

Enrollment

Registered

2026-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.Intra-Aortic Balloon Catheter (IABP) radiographic position rate 2.Major Adverse Cardiac and Cerebrovascular Events (MACCE) 3.Major Device-Related Adverse Events Timepoint: 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	—

Measure

Time frame

1.Intra-Aortic Balloon Catheter (IABP) radiographic position rate 2.Major Adverse Cardiac and Cerebrovascular Events (MACCE) 3.Major Device-Related Adverse Events Timepoint: 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

Measure	Time frame
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-36Timepoint: 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	—

Measure

Time frame

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-36Timepoint: 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

—

Countries

India

Contacts

Public ContactDr Kiran Kumar Shetty

Meril LIfe Science Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026