Mitral RegurgitationPMVI-PiPNCT04156295
Percutaneous Mitral Valve Intervention: Predicting Improvements in Left Ventricular Performance
An observational study of Mitral Regurgitation and Mitral Valve Insufficiency, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the role of cardiac imaging combined with demographic, clinical, and biochemical parameters in predicting outcomes following percutaneous mitral valve intervention in order to facilitate more careful risk stratification, interventional planning and avoidance of high risk futile… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Valve Insufficiency
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Mar 2019to 31 Dec 2020
- 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: This study will be performed across two sites, namely Guy's and St Thomas' and King' College Hospitals. Patients will be recruited based on referral to GSTT or KCH, a diagnosis of mitral valve disease and clinical eligibility for percutaneous mitral valve intervention.
Who may be able to join
- 18 years or older
- At least moderate to severe symptomatic mitral regurgitation
- Life expectancy greater than 1 year post intervention
- Able to give informed consent
Who cannot join
- 1. Patient not eligible for percutaneous mitral valve intervention.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE17EH
About this study
The purpose of this study is to assess the role of cardiac imaging combined with demographic, clinical, and biochemical parameters in predicting outcomes following percutaneous mitral valve intervention in order to facilitate more careful risk stratification, interventional planning and avoidance of high risk futile procedures.The principle objective of this study is to determine if transthoracic echocardiography (TTE) can predict changes in left ventricular (LV) size and function following percutaneous mitral valve intervention (PMVI).
Read the detailed description
Mitral regurgitation (MR) is one of the most common valvular abnormalities affecting an estimated 5 million worldwide. Within Europe it has been recognised as the second most common valve lesion requiring surgery. By 2030, prevalence is expected to more than double as a consequence of an ageing population. Mitral regurgitation can be caused by a range of aetiologies including degenerative or functional abnormalities. Regardless of the underlying cause, severe MR commonly leads to symptoms of breathlessness and/or arrhythmia, frequently requiring hospital admission secondary to decompensated heart failure. Aside from a reduction in cardiac output secondary to the primary lesion, chronic MR also leads to significant left ventricular remodelling with dilatation and dysfunction of the left ventricle. Left untreated, such a lesion carries an annual mortality of 5%.
Conventional mitral valve surgery is the recognised gold standard therapy for patients with moderate to severe or severe mitral regurgitation, symptoms and LV impairment. However for patients with multiple comorbidities and a high surgical risk, percutaneous mitral valve intervention presents a novel viable therapeutic option.
Percutaneous mitral valve intervention offers an alternative to conventional open heart surgery via a minimally invasive route. One such percutaneous technology is the Mitra-Clip which is deployed and positioned to grasp valve leaflets and create a double orifice. The primary aim is to reduce the degree of mitral regurgitation with additional clinical outcomes focussed on symptom relief, enhanced lifestyle and longevity.
Foundation studies focussed on Mitra-clip have supported the usefulness of percutaneous technology with mainstay papers reporting a reduction in mitral regurgitation with improvement in clinical symptoms and quality of life. When compared to conventional surgery this approach has demonstrated high levels of safety and efficacy. Current research has also acknowledged positive left ventricular (LV) remodelling with improvement in ejection fraction and reduction in LV size as a consequence of percutaneous mitral valve intervention.
Cardiac imaging is crucial in the preoperative, device deployment and post intervention phases of PMVI. TTE, recognised as the mainstay imaging modality in valvular heart disease, allows for both quantitative and qualitative evaluation of mitral regurgitation. Moreover, comprehensive assessment of LV size and function can be performed. More recently, very early myocardial impairment has been demonstrated using a number of sophisticated echocardiographic markers. Additionally, functional testing including exercise stress echocardiography has proven diagnostic relevance when uncovering valvular causes of dyspnoea. Unfortunately the usefulness of both of these echo derived markers in patients with significant mitral regurgitation undergoing PMVI is poorly understood, demonstrating the need for further characterisation of these markers in this cohort.
The aim is to assess the impact of percutaneous mitral valve intervention on markers of LV function and the usefulness of functional testing in predicting changes in LV performance. The investigators propose that cardiac imaging, functional testing and clinical and laboratory data can be used to predict changes in left ventricular size and function following percutaneous mitral valve intervention.
Trial objectives and purpose
The purpose of this study is to assess the role of cardiac imaging combined with demographic, clinical, and biochemical parameters in predicting outcomes following percutaneous mitral valve intervention in order to facilitate more careful risk stratification, interventional planning and avoidance of high risk futile procedures.
The principle objective of this study is to determine if transthoracic echocardiography (TTE) can predict changes in left ventricular (LV) size and function following percutaneous mitral valve intervention (PMVI).
The secondary objectives are:
- Evaluation of the usefulness of functional testing, namely exercise stress echocardiography (ESE), and its role in discriminating mitral regurgitation (MR) patients who demonstrate improved LV parameters following PMVI from those who do not.
- Assessment of the relationship between TTE, ESE, Cardiac Magnetic Resonance (CMR) and Cardiac Computed Tomography (CT) for these patients.
- Assessment of the relationship between improvements in LV performance and the degree of residual MR.
- Exploration and characterisation of the relationship between changes in LV parameters and clinical outcomes.
- Assessment of the usefulness of TTE parameters combined with functional, clinical, biochemical parameters in providing a better prediction of postoperative outcomes following PMVI.
- Exploration of the relationship between improved outcomes and right ventricular (RV) size and function and right ventricular systolic pressures (RVSP).
- Conditions
- Mitral Regurgitation, Mitral Valve Insufficiency
- Medical subject headings
- Mitral Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LV size
Change in LV size by two dimensional linear dimension (cm)
Measured: Within 3-6 months post intervention
Change in LV volume (2D)
Change in LV volume by Simpson's Biplane method (mL)
Measured: Within 3-6 months post intervention
Change in LV volume (3D)
Change in LV volume by 3D volume method (mL)
Measured: Within 3-6 months post intervention
Change in LV systolic function (2D EF)
Change in LV systolic function by Ejection Fraction by 2D method (%)
Measured: Within 3-6 months post intervention
Change in LV systolic function (3D EF)
Change in LV systolic function by Ejection Fraction by 3D method (%)
Measured: Within 3-6 months post intervention
Change in LV systolic function (GLS)
Change in LV systolic function by Global Longitudinal strain (GLS) by 3D method
Measured: Within 3-6 months post intervention
Change in LV systolic function (EF1)
Change in LV systolic function by First Phase Ejection Fraction (%)
Measured: Within 3-6 months post intervention
Secondary outcomes (11)
Change in clinical outcomes - symptoms
Change in symptoms ( Borg scoring; 0 - lowest = 10 - highest.)
Measured: Within 3-6 months post intervention
Change in clinical outcomes - NYHA class
Change in NHYA class (NHYA class grading)
Measured: Within 3-6 months post intervention
Change in clinical outcomes - Quality of Life
Change in quality of life (Short Form (36) Health Survey) (Score 0-most disability; 100-least disability).
Measured: Within 3-6 months post intervention
Change in clinical outcomes - 6MWT
Change in exercise capacity (6 min walk test distance in metres)
Measured: Within 3-6 months post intervention
Change in clinical outcomes - NT Pro BNP
Change in biomarkers - NT pro BNP (ng/L)
Measured: Within 3-6 months post intervention
Change in clinical outcomes - ST2, Gal-3, TropT
Change in biomarkers - ST2, Galectin 3 and Trop T (ng/mL)
Measured: Within 3-6 months post intervention
Change in clinical outcomes - residual MR
Change in degree of mitral regurgitation (severity grading; 0-none or trivial; 4-severe)
Measured: Within 3-6 months post intervention
Change in clinical outcomes - RV S'
Change in right ventricular performance (RV S' (ms))
Measured: Within 3-6 months post intervention
Change in clinical outcomes - RV Strain
Change in right ventricular performance (strain %)
Measured: Within 3-6 months post intervention
Change in clinical outcomes - RV Strain Rate
Change in right ventricular performance (s-1; (strain per time unit equals velocity difference per unit length).
Measured: Within 3-6 months post intervention
Change in clinical outcomes - RVSP
Change in right ventricular performance (Right ventricular systolic pressure - mmHg)
Measured: Within 3-6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start20 Mar 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Manchester Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Bernard Prendergast, B Med Sc DM, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156295
- Sponsor's protocol ID
- 248271
- Acronym
- PMVI-PiP
- Status last verified
- Jul 2021
- First submitted
- 16 Oct 2019
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given this is a pilot study with much of the data a result of tests considered routine practice, the project is unlikely to generate new IP. However any new IP generated by the research will be owned by Guy's and St Thomas' NHS Foundation Trust. We will not share the data we collect as we have not consented for this however we aim to publish and disseminate our anonymised findings so that the value of this information can be used and applied by others working in the same field.
Publications
Attizzani GF, Fares A, Tam CC, Padaliya B, Mazzurco S, Popovich KL, Davis AC, Staunton E, Bezerra HG, Markowitz A, Simon DI, Costa MA, Sareyyupoglu B. Transapical Mitral Valve Implantation for the Treatment of Severe Native Mitral Valve Stenosis in a Prohibitive Surgical Risk Patient: Importance of Comprehensive Cardiac Computed Tomography Procedural Planning. JACC Cardiovasc Interv. 2015 Sep;8(11):1522-1525. doi: 10.1016/j.jcin.2015.04.025. Epub 2015 Aug 19. No abstract available.
PubMed 26298225Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. doi: 10.1016/j.jacc.2008.05.007. No abstract available.
PubMed 18848134De Backer O, Piazza N, Banai S, Lutter G, Maisano F, Herrmann HC, Franzen OW, Sondergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014 Jun;7(3):400-9. doi: 10.1161/CIRCINTERVENTIONS.114.001607. No abstract available.
PubMed 24944303Kelley C, Lazkani M, Farah J, Pershad A. Percutaneous mitral valve repair: A new treatment for mitral regurgitation. Indian Heart J. 2016 May-Jun;68(3):399-404. doi: 10.1016/j.ihj.2015.08.025. Epub 2016 Jan 12.
PubMed 27316505Feldman T, Kar S, Elmariah S, Smart SC, Trento A, Siegel RJ, Apruzzese P, Fail P, Rinaldi MJ, Smalling RW, Hermiller JB, Heimansohn D, Gray WA, Grayburn PA, Mack MJ, Lim DS, Ailawadi G, Herrmann HC, Acker MA, Silvestry FE, Foster E, Wang A, Glower DD, Mauri L; EVEREST II Investigators. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II. J Am Coll Cardiol. 2015 Dec 29;66(25):2844-2854. doi: 10.1016/j.jacc.2015.10.018.
PubMed 26718672Pedrazzini GB, Faletra F, Vassalli G, Demertzis S, Moccetti T. Mitral regurgitation. Swiss Med Wkly. 2010 Jan 23;140(3-4):36-43. doi: 10.4414/smw.2010.12893.
PubMed 19950042Poulin F, Carasso S, Horlick EM, Rakowski H, Lim KD, Finn H, Feindel CM, Greutmann M, Osten MD, Cusimano RJ, Woo A. Recovery of left ventricular mechanics after transcatheter aortic valve implantation: effects of baseline ventricular function and postprocedural aortic regurgitation. J Am Soc Echocardiogr. 2014 Nov;27(11):1133-42. doi: 10.1016/j.echo.2014.07.001. Epub 2014 Aug 7.
PubMed 25125314Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.
PubMed 22922698
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Mitral Valve Intervention: Predicting Improvements in Left Ventricular Performance
- ClinicalTrials.gov ID
- NCT04156295
- Acronym / sponsor ID
- PMVI-PiP / 248271
- Conditions
- Mitral Regurgitation, Mitral Valve Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Manchester Metropolitan University
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Nov 2019 (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.
The purpose of this study is to assess the role of cardiac imaging combined with demographic, clinical, and biochemical parameters in predicting outcomes following percutaneous mitral valve intervention in order to facilitate more careful risk stratification, interventional planning and avoidance of high risk futile procedures.The principle objective of this study is to determine if transthoracic echocardiography (TTE) can predict changes in left ventricular (LV) size and function following percutaneous mitral valve intervention (PMVI).
Detailed description
Mitral regurgitation (MR) is one of the most common valvular abnormalities affecting an estimated 5 million worldwide. Within Europe it has been recognised as the second most common valve lesion requiring surgery. By 2030, prevalence is expected to more than double as a consequence of an ageing population. Mitral regurgitation can be caused by a range of aetiologies including degenerative or functional abnormalities. Regardless of the underlying cause, severe MR commonly leads to symptoms of breathlessness and/or arrhythmia, frequently requiring hospital admission secondary to decompensated heart failure. Aside from a reduction in cardiac output secondary to the primary lesion, chronic MR also leads to significant left ventricular remodelling with dilatation and dysfunction of the left ventricle. Left untreated, such a lesion carries an annual mortality of 5%.
Conventional mitral valve surgery is the recognised gold standard therapy for patients with moderate to severe or severe mitral regurgitation, symptoms and LV impairment. However for patients with multiple comorbidities and a high surgical risk, percutaneous mitral valve intervention presents a novel viable therapeutic option.
Percutaneous mitral valve intervention offers an alternative to conventional open heart surgery via a minimally invasive route. One such percutaneous technology is the Mitra-Clip which is deployed and positioned to grasp valve leaflets and create a double orifice. The primary aim is to reduce the degree of mitral regurgitation with additional clinical outcomes focussed on symptom relief, enhanced lifestyle and longevity.
Foundation studies focussed on Mitra-clip have supported the usefulness of percutaneous technology with mainstay papers reporting a reduction in mitral regurgitation with improvement in clinical symptoms and quality of life. When compared to conventional surgery this approach has demonstrated high levels of safety and efficacy. Current research has also acknowledged positive left ventricular (LV) remodelling with improvement in ejection fraction and reduction in LV size as a consequence of percutaneous mitral valve intervention.
Cardiac imaging is crucial in the preoperative, device deployment and post intervention phases of PMVI. TTE, recognised as the mainstay imaging modality in valvular heart disease, allows for both quantitative and qualitative evaluation of mitral regurgitation. Moreover, comprehensive assessment of LV size and function can be performed. More recently, very early myocardial impairment has been demonstrated using a number of sophisticated echocardiographic markers. Additionally, functional testing including exercise stress echocardiography has proven diagnostic relevance when uncovering valvular causes of dyspnoea. Unfortunately the usefulness of both of these echo derived markers in patients with significant mitral regurgitation undergoing PMVI is poorly understood, demonstrating the need for further characterisation of these markers in this cohort.
The aim is to assess the impact of percutaneous mitral valve intervention on markers of LV function and the usefulness of functional testing in predicting changes in LV performance. The investigators propose that cardiac imaging, functional testing and clinical and laboratory data can be used to predict changes in left ventricular size and function following percutaneous mitral valve intervention.
Trial objectives and purpose
The purpose of this study is to assess the role of cardiac imaging combined with demographic, clinical, and biochemical parameters in predicting outcomes following percutaneous mitral valve intervention in order to facilitate more careful risk stratification, interventional planning and avoidance of high risk futile procedures.
The principle objective of this study is to determine if transthoracic echocardiography (TTE) can predict changes in left ventricular (LV) size and function following percutaneous mitral valve intervention (PMVI).
The secondary objectives are:
- Evaluation of the usefulness of functional testing, namely exercise stress echocardiography (ESE), and its role in discriminating mitral regurgitation (MR) patients who demonstrate improved LV parameters following PMVI from those who do not.
- Assessment of the relationship between TTE, ESE, Cardiac Magnetic Resonance (CMR) and Cardiac Computed Tomography (CT) for these patients.
- Assessment of the relationship between improvements in LV performance and the degree of residual MR.
- Exploration and characterisation of the relationship between changes in LV parameters and clinical outcomes.
- Assessment of the usefulness of TTE parameters combined with functional, clinical, biochemical parameters in providing a better prediction of postoperative outcomes following PMVI.
- Exploration of the relationship between improved outcomes and right ventricular (RV) size and function and right ventricular systolic pressures (RVSP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be performed across two sites, namely Guy's and St Thomas' and King' College Hospitals. Patients will be recruited based on referral to GSTT or KCH, a diagnosis of mitral valve disease and clinical eligibility for percutaneous mitral valve intervention.
Key inclusion criteria (4 listed)
- 18 years or older
- At least moderate to severe symptomatic mitral regurgitation
- Life expectancy greater than 1 year post intervention
- Able to give informed consent
Key exclusion criteria (1 listed)
- 1. Patient not eligible for percutaneous mitral valve intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in LV size
Time frame: Within 3-6 months post intervention
Change in LV size by two dimensional linear dimension (cm)
Change in LV volume (2D)
Time frame: Within 3-6 months post intervention
Change in LV volume by Simpson's Biplane method (mL)
Change in LV volume (3D)
Time frame: Within 3-6 months post intervention
Change in LV volume by 3D volume method (mL)
Change in LV systolic function (2D EF)
Time frame: Within 3-6 months post intervention
Change in LV systolic function by Ejection Fraction by 2D method (%)
Change in LV systolic function (3D EF)
Time frame: Within 3-6 months post intervention
Change in LV systolic function by Ejection Fraction by 3D method (%)
Change in LV systolic function (GLS)
Time frame: Within 3-6 months post intervention
Change in LV systolic function by Global Longitudinal strain (GLS) by 3D method
Change in LV systolic function (EF1)
Time frame: Within 3-6 months post intervention
Change in LV systolic function by First Phase Ejection Fraction (%)
11 secondary outcomes
Change in clinical outcomes - symptoms
Time frame: Within 3-6 months post intervention
Change in clinical outcomes - NYHA class
Time frame: Within 3-6 months post intervention
Change in clinical outcomes - Quality of Life
Time frame: Within 3-6 months post intervention
Change in clinical outcomes - 6MWT
Time frame: Within 3-6 months post intervention
Change in clinical outcomes - NT Pro BNP
Time frame: Within 3-6 months post intervention
Change in clinical outcomes - ST2, Gal-3, TropT
Time frame: Within 3-6 months post intervention
Change in clinical outcomes - residual MR
Time frame: Within 3-6 months post intervention
Change in clinical outcomes - RV S'
Time frame: Within 3-6 months post intervention
Change in clinical outcomes - RV Strain
Time frame: Within 3-6 months post intervention
Change in clinical outcomes - RV Strain Rate
Time frame: Within 3-6 months post intervention
Change in clinical outcomes - RVSP
Time frame: Within 3-6 months post intervention
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 29 Jul 2021.
- Background: PubMed 26298225Attizzani GF, Fares A, Tam CC, Padaliya B, Mazzurco S, Popovich KL, Davis AC, Staunton E, Bezerra HG, Markowitz A, Simon DI, Costa MA, Sareyyupoglu B. Transapical Mitral Valve Implantation for the Treatment of Severe Native Mitral Valve Stenosis in a Prohibitive Surgical Risk Patient: Importance of Comprehensive Cardiac Computed Tomography Procedural Planning. JACC Cardiovasc Interv. 2015 Sep;8(11):1522-1525. doi: 10.1016/j.jcin.2015.04.025. Epub 2015 Aug 19. No abstract available.
- Background: PubMed 18848134Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. doi: 10.1016/j.jacc.2008.05.007. No abstract available.
- Background: PubMed 24944303De Backer O, Piazza N, Banai S, Lutter G, Maisano F, Herrmann HC, Franzen OW, Sondergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014 Jun;7(3):400-9. doi: 10.1161/CIRCINTERVENTIONS.114.001607. No abstract available.
- Background: PubMed 27316505Kelley C, Lazkani M, Farah J, Pershad A. Percutaneous mitral valve repair: A new treatment for mitral regurgitation. Indian Heart J. 2016 May-Jun;68(3):399-404. doi: 10.1016/j.ihj.2015.08.025. Epub 2016 Jan 12.
- Background: PubMed 26718672Feldman T, Kar S, Elmariah S, Smart SC, Trento A, Siegel RJ, Apruzzese P, Fail P, Rinaldi MJ, Smalling RW, Hermiller JB, Heimansohn D, Gray WA, Grayburn PA, Mack MJ, Lim DS, Ailawadi G, Herrmann HC, Acker MA, Silvestry FE, Foster E, Wang A, Glower DD, Mauri L; EVEREST II Investigators. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II. J Am Coll Cardiol. 2015 Dec 29;66(25):2844-2854. doi: 10.1016/j.jacc.2015.10.018.
- Background: PubMed 19950042Pedrazzini GB, Faletra F, Vassalli G, Demertzis S, Moccetti T. Mitral regurgitation. Swiss Med Wkly. 2010 Jan 23;140(3-4):36-43. doi: 10.4414/smw.2010.12893.
- Background: PubMed 25125314Poulin F, Carasso S, Horlick EM, Rakowski H, Lim KD, Finn H, Feindel CM, Greutmann M, Osten MD, Cusimano RJ, Woo A. Recovery of left ventricular mechanics after transcatheter aortic valve implantation: effects of baseline ventricular function and postprocedural aortic regurgitation. J Am Soc Echocardiogr. 2014 Nov;27(11):1133-42. doi: 10.1016/j.echo.2014.07.001. Epub 2014 Aug 7.
- Background: PubMed 22922698Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.
- Individual participant dataSharing planned: No. Given this is a pilot study with much of the data a result of tests considered routine practice, the project is unlikely to generate new IP. However any new IP generated by the research will be owned by Guy's and St Thomas' NHS Foundation Trust. We will not share the data we collect as we have not consented for this however we aim to publish and disseminate our anonymised findings so that the value of this information can be used and applied by others working in the same field.
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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.
Bernard Prendergast, B Med Sc DM principal investigator
Guy's and St Thomas' NHS Foundation 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 Mitral Valve Insufficiency, run by Guy's and St Thomas' NHS Foundation 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 4 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: finished, as of the sponsor's last update on 29 Jul 2021. 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?
Change in LV size (time frame: Within 3-6 months post intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04156295, which also lists 8 linked publications.
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 29 Jul 2021.