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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives.
Transcatheter edge-to-edge repair (TEER) procedures have increasingly been used to improve the severity of both MR and TR, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. The standard of care in the UK, and particularly in Oxford, emphasises fewer investigations before the TEER procedure and shorter length of hospital stay.
This prospective, observational cohort study will examine the safety and feasibility of this practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with either mitral TEER, tricuspid TEER or both | Patients treated with either mitral TEER, tricuspid TEER or both, at John Radcliffe Hospital, Oxford |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early discharge protocol | Behavioral | Patients admitted for transcatheter edge-to-edge repair to either mitral or tricuspid valve and then discharged within 36 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients discharged 'early' after edge -to-edge repair | defined as < 36 hours after completion of procedure | up to 30 days |
| All - cause rehospitalisation after completion of procedure | Any hospital admission after discharge from the index procedure | 30 days, 1 year |
| All cause death after completion of procedure | All patient death following discharge after the index procedure | 30 days, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | Length of hospital stay from admission to discharge for outpatient procedures, or from procedure to discharge for inpatient procedures | Up to 3 months |
| Proportion of patients requiring intensive care unit care |
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Inclusion Criteria:
Exclusion Criteria:
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Participants aged ≥18 years referred for either mitral or tricuspid TEER (or both) and found to be eligible candidates after review by the Oxford Heart Team.
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| Name | Affiliation | Role |
|---|---|---|
| Sam Dawkins, MBBS MRCP BSc DPhil | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D014262 | Tricuspid Valve Insufficiency |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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The proportion of patients admitted to intensive care unit after their procedure
| Up to 3 months |
| Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days | Evaluating safety a. Major adverse events (procedure/device related) at the time of procedure b. Major adverse events (procedure/device related) up to 30 days (including unplanned surgery relating to a device/procedural complication) | During index admission up to 30 days post procedure. |
| Symptomatic improvement | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from pre-procedure to post-procedure (validated score for assessing symptoms, physical and social limitations, and quality of life in patients with heart failure, score 0-100, where 100 = no symptoms). | 3 months, 1 year |
| Heart failure hospitalisation | Any heart failure related hospitalisations after the index procedure | 30 days, 1 year |