Post market surveillance enrolling all consented patients receiving the MitraClip device

Mitra Clip India Post Market Surveillance - n/a

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/08/027441

Enrollment

110

Registered

2020-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: I340- Nonrheumatic mitral (valve) insufficiency

Interventions

Intervention1: MitraClip: Post market surveillance enrolling all consented patients receiving the MitraClip device per the current indications for use Control Intervention1: N/A: N/A

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject must provide written informed consent prior to any PMS-related procedure. 2.Subject who are eligible to receive the MitraClip per the approved IFU in India

Exclusion criteria

Exclusion criteria: N/A There is no specified exclusion criteria for the patients. All patients eligible for a MitraClip procedure per the approved IFU in India, and who provide their consent for participation will be enrolled in the surveillance

Design outcomes

Primary

Measure	Time frame
The primary objective of this surveillance is to confirm the acute safety and effectiveness of the MitraClip System in Indian Population.Timepoint: n/a	—

Secondary

Measure	Time frame
Adverse Events or device deficiencies (discharge, 30 days) All AEs and device deficiencies including SLDAs, stenosis, device embolization etc.Timepoint: Discharge & 30days post implant;All-cause mortality (discharge, 30 days)Timepoint: Discharge & 30days post implant;Freedom from Major Adverse Events (MAE) (30 days) MAE is defined as composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal accessTimepoint: 30days post implant;MR Severity (baseline, discharge, 30 days)Timepoint: Baseline, Discharge & 30days post implant;NYHA Functional ClassTimepoint: Baseline, discharge, and 30 days;Reintervention (discharge, 30 days) Mitral valve surgery or re-intervention with MitraClipTimepoint: Discharge & 30days post implant	—

Measure

Time frame

Adverse Events or device deficiencies (discharge, 30 days) All AEs and device deficiencies including SLDAs, stenosis, device embolization etc.Timepoint: Discharge & 30days post implant;All-cause mortality (discharge, 30 days)Timepoint: Discharge & 30days post implant;Freedom from Major Adverse Events (MAE) (30 days) MAE is defined as composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal accessTimepoint: 30days post implant;MR Severity (baseline, discharge, 30 days)Timepoint: Baseline, Discharge & 30days post implant;NYHA Functional ClassTimepoint: Baseline, discharge, and 30 days;Reintervention (discharge, 30 days) Mitral valve surgery or re-intervention with MitraClipTimepoint: Discharge & 30days post implant

—

Countries

India

Contacts

Public ContactDr Sumit Anand

St Jude Medical India Pvt.Ltd.

sumit.anand@abbott.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026