Comparison of urgent surgery with clot dissolving drug therapy to find out a better treatment option for patient having symptoms and condition of blood clot in left sided artificially implanted valve.

Surgery compared to fibrinolytic therapy for symptomatic patients with left-sided prosthetic heart valve thrombosis - SAFE-PVT study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/10/010159

Enrollment

Registered

2017-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: null- Recent-onset (=2 weeks), objectively diagnosed, symptomatic (NYHA class II-IV) left-sided prosthetic valve dysfunction

Interventions

Intervention1: Fibrinolytic Therapy: Patients will receive streptokinase (SK) at a dose of 0.25MU over 30 minutes followed by a 0.1MU/ hour infusion. Infusions of SK will be continued for up to 72-96

Eligibility

Inclusion criteria

Inclusion criteria: All patients over 18 years of age with recent-onset (=2 weeks), objectively diagnosed, symptomatic (NYHA class II-IV) left-sided prosthetic valve dysfunction

Exclusion criteria

Exclusion criteria: i. Absolute contraindications to FT (any history of intracranial hemorrhage, active bleeding from any site, ischemic stroke in the preceding 3 months, left atrial thrombus on TTE) ii. Pregnant patients iii. Asymptomatic patients (incidentally detected valve thrombosis) iv. Inability to obtain (or refusal to provide) informed consent

Design outcomes

Primary

Measure	Time frame
The primary outcome is the occurrence of a complete clinical response, defined as discharge from hospital with completely restored valve function, in the absence of stroke, major bleeding or non-CNS systemic embolism. Complete restoration of valve function consists of (1) restoration of normal leaflet motion on fluoroscopy, and (2) normalization of transvalvular pressure gradients on Doppler echocardiography (mitral MDG6mmHg and EDG2mmHg, and aortic peak gradient30mmHg).Timepoint: At discharge	—

Measure

Time frame

The primary outcome is the occurrence of a complete clinical response, defined as discharge from hospital with completely restored valve function, in the absence of stroke, major bleeding or non-CNS systemic embolism. Complete restoration of valve function consists of (1) restoration of normal leaflet motion on fluoroscopy, and (2) normalization of transvalvular pressure gradients on Doppler echocardiography (mitral MDG6mmHg and EDG2mmHg, and aortic peak gradient30mmHg).Timepoint: At discharge

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Secondary

Measure	Time frame
The first secondary outcome is the occurrence of a composite of in-hospital death, stroke, major bleeding or non-CNS systemic embolism. This is the principal safety outcome. We will also determine the occurrence of a composite of death, recurrent PVT, stroke or non-CNS systemic embolism, and persistent abnormal valve function (or re-do surgery for persistent valve dysfunction), at one-year follow-up.Timepoint: 1) Hospital discharge 2) One year follow-up	—

Measure

Time frame

The first secondary outcome is the occurrence of a composite of in-hospital death, stroke, major bleeding or non-CNS systemic embolism. This is the principal safety outcome. We will also determine the occurrence of a composite of death, recurrent PVT, stroke or non-CNS systemic embolism, and persistent abnormal valve function (or re-do surgery for persistent valve dysfunction), at one-year follow-up.Timepoint: 1) Hospital discharge 2) One year follow-up

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Countries

India

Contacts

Public ContactDr G Karthikeyan

AIIMS

karthik2010@gmail.com011-26594464

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 8, 2026