Functional Mitral RegurgitationPOPNCT00947921
Plasty or Prosthesis to Treat Functional Mitral Regurgitation
A study testing Plasty and Prosthesis in people with Functional Mitral Regurgitation, run by Cardiochirurgia E.H. at 1 site in Italy.
Trial summary
Functional Mitral regurgitation is a now well known entity due to tethering of the valve either mono-lateral, as happens in lateral myocardial infarction, or bilateral as happens in dilated cardiomyopathy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- Plasty and Prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2009to Aug 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients presenting for surgery due to functional mitral regurgitation
Who cannot join
- Associated Heart Surgery procedures other than CABG, Tricuspid Regurgitation correction, Atrial Fibrillation Correction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study
Functional Mitral regurgitation is a now well known entity due to tethering of the valve either mono-lateral, as happens in lateral myocardial infarction, or bilateral as happens in dilated cardiomyopathy. Treatment of this pathology, either conserving the valve and addressing regurgitation by mean of restrictive annuloplasty, or implanting a prosthesis remains controversial in terms of mid and long term benefit for the patient. The investigators propose a randomized controlled study to compare the efficacy of both technique in terms of mortality and freedom from reintervention.
- Conditions
- Functional Mitral Regurgitation
- Being tested
- Plasty, Prosthesis
- Keywords
- Functional MItral regurgitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlastyProcedure or surgery
Restrictive Annuloplasty
ProsthesisProcedure or surgery
Valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Plasty | Active comparator | Patients treated with restrictive Annuloplasty Receives: Procedure: Plasty |
| Prosthesis | Active comparator | Patients treated with valve replacement Receives: Procedure: Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 1 year of follow up after discharge from hospital
Secondary outcomes (1)
Freedom from reintervention
Measured: 1 year of follow-up after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Weltert, Cardiochirurgia E.H.
- Investigators
- Luca Weltert, MD, Principal investigator, Cardiochirurgia E.H.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947921
- Sponsor's protocol ID
- 00-01
- Acronym
- POP
- Status last verified
- Jan 2018
- First submitted
- 23 Jul 2009
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT00947921
- Acronym / sponsor ID
- POP / 00-01
- Conditions
- Functional Mitral Regurgitation
- Keywords
- Functional MItral regurgitation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 28 Jul 2009 (estimated)
- 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.
Functional Mitral regurgitation is a now well known entity due to tethering of the valve either mono-lateral, as happens in lateral myocardial infarction, or bilateral as happens in dilated cardiomyopathy. Treatment of this pathology, either conserving the valve and addressing regurgitation by mean of restrictive annuloplasty, or implanting a prosthesis remains controversial in terms of mid and long term benefit for the patient. The investigators propose a randomized controlled study to compare the efficacy of both technique in terms of mortality and freedom from reintervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasty | Active comparator | Procedure: PlastyPatients treated with restrictive Annuloplasty |
| Prosthesis | Active comparator | Procedure: ProsthesisPatients treated with valve replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients presenting for surgery due to functional mitral regurgitation
Key exclusion criteria (1 listed)
- Associated Heart Surgery procedures other than CABG, Tricuspid Regurgitation correction, Atrial Fibrillation Correction
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 |
|---|---|---|
| PlastyRestrictive Annuloplasty | Procedure or surgery | Plasty |
| ProsthesisValve replacement | Procedure or surgery | Prosthesis |
Primary outcome
Mortality
Time frame: 1 year of follow up after discharge from hospital
1 secondary outcome
Freedom from reintervention
Time frame: 1 year of follow-up after discharge from hospital
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
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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.
Luca Weltert, MD principal investigator
Cardiochirurgia E.H.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasty and Prosthesis in people with Functional Mitral Regurgitation, run by Cardiochirurgia E.H. at 1 site in Italy.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 26 Jan 2018. 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 Italy. 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 was stopped early. Results are not available in the source record.
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?
Mortality (time frame: 1 year of follow up after discharge from hospital). 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 26 Jan 2018.