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.
Phase 4
- Conditions
- Health Condition 1: null- Recent-onset (=2 weeks), objectively diagnosed, symptomatic (NYHA class II-IV) left-sided prosthetic valve dysfunction
- Registration Number
- CTRI/2017/10/010159
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>2) One year follow-up