Mitral RegurgitationEARLY-EdgeNCT06343363
Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety
An observational study of Mitral Regurgitation and Tricuspid Regurgitation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Tricuspid Regurgitation, Mitral Repair
- What is being tested?
- Early discharge protocol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 127 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2023to 11 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Aged ≥18 years
- Accepted by Heart Team for TEER (mitral and/or tricuspid)
- Willing and able to give informed consent for participation in the study.
- Regurgitation (mitral and/or tricuspid) grade ≥2+ as assessed by echocardiography
- Patient is willing and able to attend all follow-up visits
Who cannot join
- Patients in whom safety or clinical concerns preclude participation
- Patient declines to be involved in the study (unwilling to consent to enrolment or deemed by the patient advocate to be unwilling to consent)
- Patient in whom a TOE is contraindicated, or screening TOE is unsuccessful
- Pregnant or planning pregnancy within next 12 months
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- Patients requiring emergency TEER
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
About this study
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.
- Being tested
- Early discharge protocol
- Keywords
- transcatheter edge-to-edge repair, mitral TEER, mitral regurgitation, tricuspid regurgitation
- Medical subject headings
- Mitral Valve Insufficiency, Tricuspid Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early discharge protocolBehavioural
Patients admitted for transcatheter edge-to-edge repair to either mitral or tricuspid valve and then discharged within 36 hours
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Early discharge protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients discharged 'early' after edge -to-edge repair
defined as < 36 hours after completion of procedure
Measured: up to 30 days
All - cause rehospitalisation after completion of procedure
Any hospital admission after discharge from the index procedure
Measured: 30 days, 1 year
All cause death after completion of procedure
All patient death following discharge after the index procedure
Measured: 30 days, 1 year
Secondary outcomes (5)
Hospital length of stay
Length of hospital stay from admission to discharge for outpatient procedures, or from procedure to discharge for inpatient procedures
Measured: Up to 3 months
Proportion of patients requiring intensive care unit care
The proportion of patients admitted to intensive care unit after their procedure
Measured: 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)
Measured: 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).
Measured: 3 months, 1 year
Heart failure hospitalisation
Any heart failure related hospitalisations after the index procedure
Measured: 30 days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 May 2023
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Sam Dawkins, Oxford University Hospitals NHS Trust
- Investigators
- Sam Dawkins, MBBS MRCP BSc DPhil, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343363
- Sponsor's protocol ID
- 318352
- Acronym
- EARLY-Edge
- Status last verified
- Jun 2025
- First submitted
- 29 Oct 2023
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety
- ClinicalTrials.gov ID
- NCT06343363
- Acronym / sponsor ID
- EARLY-Edge / 318352
- Keywords
- transcatheter edge-to-edge repair, mitral TEER, mitral regurgitation, tricuspid regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 1 May 2023 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with either mitral TEER, tricuspid TEER or both | – | Behavioral: Early discharge protocolPatients treated with either mitral TEER, tricuspid TEER or both, at John Radcliffe Hospital, Oxford |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Aged ≥18 years
- Accepted by Heart Team for TEER (mitral and/or tricuspid)
- Willing and able to give informed consent for participation in the study.
- Regurgitation (mitral and/or tricuspid) grade ≥2+ as assessed by echocardiography
- Patient is willing and able to attend all follow-up visits
Key exclusion criteria (6 listed)
- Patients in whom safety or clinical concerns preclude participation
- Patient declines to be involved in the study (unwilling to consent to enrolment or deemed by the patient advocate to be unwilling to consent)
- Patient in whom a TOE is contraindicated, or screening TOE is unsuccessful
- Pregnant or planning pregnancy within next 12 months
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early discharge protocolPatients admitted for transcatheter edge-to-edge repair to either mitral or tricuspid valve and then discharged within 36 hours | Behavioural | Patients treated with either mitral TEER, tricuspid TEER or both |
Primary outcome
Proportion of patients discharged 'early' after edge -to-edge repair
Time frame: up to 30 days
defined as < 36 hours after completion of procedure
All - cause rehospitalisation after completion of procedure
Time frame: 30 days, 1 year
Any hospital admission after discharge from the index procedure
All cause death after completion of procedure
Time frame: 30 days, 1 year
All patient death following discharge after the index procedure
5 secondary outcomes
Hospital length of stay
Time frame: Up to 3 months
Proportion of patients requiring intensive care unit care
Time frame: 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
Time frame: During index admission up to 30 days post procedure.
Symptomatic improvement
Time frame: 3 months, 1 year
Heart failure hospitalisation
Time frame: 30 days, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Dawkins, MBBS MRCP BSc DPhil principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Tricuspid Regurgitation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients discharged 'early' after edge -to-edge repair (time frame: up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.