Mitral Valve ProlapseCAMRANCT02552771
The Canadian Mitral Research Alliance (CAMRA) Trial CardioLink-2
A study testing Mitral repair with leaflet preservation and Mitral repair with leaflet resection in people with Mitral Valve Prolapse, run by Unity Health Toronto at 6 sites in Canada.
Trial summary
Multicentre, double-armed, randomized controlled trial designed to compare mitral valve leaflet resection versus leaflet preservation with regards to the development of functional mitral stenosis following surgical repair of mitral valve prolapse. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve Prolapse
- What is being tested?
- Mitral repair with leaflet preservation and Mitral repair with leaflet resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 6 sitesCanada
- Study dates
- Jan 2016to Jan 2020
- 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
- Patients with mitral regurgitation and mitral valve prolapse who are scheduled for elective mitral valve repair by an experienced mitral valve repair surgeon (>15 degenerative mitral valve repairs per year, with a repair rate>90%, and able to perform mitral repair with either a leaflet resection or leaflet preservation strategy).
- Planned mitral valve repair amenable to either a leaflet resection or leaflet preservation surgical repair strategy
Who cannot join
- Patients with anterior leaflet or commissural prolapse
- Patients with endocarditis or rheumatic mitral valve disease
- Patients with mitral annular calcification extending beyond the circumference of one leaflet scallop
- Patients with significant LV dysfunction defined as a LVEF <40%
- Patients undergoing concomitant aortic valve surgery
- Patients unable to undergo bicycle ergometry
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Not yet recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Victor Fan Chu, MD, 1 905 523-0440, chu@HHSC.CA
Richard Whitlock, MD, Richard.Whitlock@phri.ca
- Not yet recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
Michael Chu, MD, (519) 663-3593, Michael.Chu@lhsc.on.ca
Stephanie Fox, 519-685-8500 ext. 35031, Stephanie.Fox@lhsc.on.ca
- Recruiting
McGill University Health Center
Montreal, Quebec, H4A 3J1
Benoit de Varennes, MD, 514-934-1934 ext. 34980, benoit.devarennes@muhc.mcgill.ca
Carole Albert, 514-934-1934 ext. 35277, carole.albert@muhc.mcgill.ca
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Vincent Chan, MD, 613-798-5555 ext. 14253, VChan@ottawaheart.ca
Jacqueline Fortier, Msc, 613-798-5555 ext. 18329, JFortier@ottawaheart.ca
- Not yet recruiting
Memorial University
St. John's, Newfoundland and Labrador
Corey Adams, MD, 709-777-2296
Corey Adams, MD
- Recruiting
St Michael's Hospital
Toronto, Ontario, M5B1W8
Subodh Verma, MD, (416) 864-5997, vermasu@smh.ca
Sanjay Yagnik, 416-864-6060 ext. 6690, YagnikS@smh.ca
About this study
Official title: A Randomized Trial of Mitral Valve Repair With Leaflet Resection Versus Leaflet Preservation on Functional Mitral Stenosis: The Canadian Mitral Research Alliance (CAMRA-1) Trial
Multicentre, double-armed, randomized controlled trial designed to compare mitral valve leaflet resection versus leaflet preservation with regards to the development of functional mitral stenosis following surgical repair of mitral valve prolapse. Patients will be randomized (1:1) to receive: (1) mitral valve repair with a leaflet resection or (2) mitral valve repair with leaflet preservation (using polytetrafluoroethylene neochordae), followed by echocardiographic and clinical assessment at 12-months following surgery.
Read the detailed description
Mitral valve repair has emerged as the preferred surgical treatment for mitral valve prolapse (MVP), a condition wherein the mitral valve does not close properly. One common strategy for mitral valve repair is leaflet resection, which involves removing part of one or both of the mitral leaflets that flop or bulge back (prolapse). Another strategy is leaflet preservation, which involves placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle). While both strategies are routinely used and lead to successful mitral valve repair, there is no clear evidence as to whether one strategy is better than the other in terms of long term outcome. The purpose of this study is to determine if one repair strategy (leaflet resection versus leaflet preservation) leads to better longer term patient outcomes. A total of 88 patients from 6 Canadian centres will be randomly assigned to one of the two strategies. The primary outcome will be functional mitral stenosis (MS) as assessed by 12-month mean mitral valve pressure gradient at peak exercise.
- Conditions
- Mitral Valve Prolapse
- Being tested
- Mitral repair with leaflet preservation, Mitral repair with leaflet resection
- Medical subject headings
- Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral repair with leaflet preservationProcedure or surgery
Placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle).
Mitral repair with leaflet resectionProcedure or surgery
Removing one or both of the mitral leaflets that flop or bulge back.
| Study group | Role | What they receive |
|---|---|---|
| Mitral repair with leaflet preservation | Active comparator | Placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle). Receives: Procedure: Mitral repair with leaflet preservation |
| Mitral repair with leaflet resection | Active comparator | Removal of one or both of the mitral leaflets that flop or bulge back. Receives: Procedure: Mitral repair with leaflet resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean mitral valve gradient at peak exercise 12-months following repair
Measured: 12 months following repair
Secondary outcomes (5)
Mitral valve area
Measured: 12 months following repair
Age/Sex predicted metabolic equivalent score
Measured: 12 months following repair
Mitral leaflet coaptation height
Measured: 12 months following repair
6-minute walk test
Measured: 12 months following repair
Composite MACE (major adverse cardiovascular event) end-point of recurrent MR ≥2+, death, or hospital re-admission for congestive heart failure within 12-months of surgery
Measured: 12 months following repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve ProlapseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation, London Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Vincent Chan, MD, Principal investigator, Ottawa Heart Institute Research CorporationSubodh Verma, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552771
- Sponsor's protocol ID
- 15-162
- Acronym
- CAMRA
- Status last verified
- Dec 2018
- First submitted
- 30 Jul 2015
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Theal M, Sleik K, Anand S, Yi Q, Yusuf S, Lonn E. Prevalence of mitral valve prolapse in ethnic groups. Can J Cardiol. 2004 Apr;20(5):511-5.
PubMed 15100753Freed LA, Levy D, Levine RA, Larson MG, Evans JC, Fuller DL, Lehman B, Benjamin EJ. Prevalence and clinical outcome of mitral-valve prolapse. N Engl J Med. 1999 Jul 1;341(1):1-7. doi: 10.1056/NEJM199907013410101.
PubMed 10387935Flack JM, Kvasnicka JH, Gardin JM, Gidding SS, Manolio TA, Jacobs DR Jr. Anthropometric and physiologic correlates of mitral valve prolapse in a biethnic cohort of young adults: the CARDIA study. Am Heart J. 1999 Sep;138(3 Pt 1):486-92. doi: 10.1016/s0002-8703(99)70151-1.
PubMed 10467199Ling LH, Enriquez-Sarano M, Seward JB, Tajik AJ, Schaff HV, Bailey KR, Frye RL. Clinical outcome of mitral regurgitation due to flail leaflet. N Engl J Med. 1996 Nov 7;335(19):1417-23. doi: 10.1056/NEJM199611073351902.
PubMed 8875918Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.
PubMed 15745978Verma S, Mesana TG. Mitral-valve repair for mitral-valve prolapse. N Engl J Med. 2009 Dec 3;361(23):2261-9. doi: 10.1056/NEJMct0806111. No abstract available.
PubMed 19955526Chan V, Malas T, Lapierre H, Boodhwani M, Lam BK, Rubens FD, Hendry PJ, Masters RG, Goldstein W, Mesana TG, Ruel M. Reoperation of left heart valve bioprostheses according to age at implantation. Circulation. 2011 Sep 13;124(11 Suppl):S75-80. doi: 10.1161/CIRCULATIONAHA.110.011973.
PubMed 21911822O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2--isolated valve surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S23-42. doi: 10.1016/j.athoracsur.2009.05.056.
PubMed 19559823Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3--valve plus coronary artery bypass grafting surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S43-62. doi: 10.1016/j.athoracsur.2009.05.055.
PubMed 19559824Ikonomidis JS, Kratz JM, Crumbley AJ 3rd, Stroud MR, Bradley SM, Sade RM, Crawford FA Jr. Twenty-year experience with the St Jude Medical mechanical valve prosthesis. J Thorac Cardiovasc Surg. 2003 Dec;126(6):2022-31. doi: 10.1016/j.jtcvs.2003.07.005.
PubMed 14688722Chan V, Jamieson WR, Lam BK, Ruel M, Ling H, Fradet G, Mesana TG. Influence of the On-X mechanical prosthesis on intermediate-term major thromboembolism and hemorrhage: a prospective multicenter study. J Thorac Cardiovasc Surg. 2010 Nov;140(5):1053-8.e2. doi: 10.1016/j.jtcvs.2009.10.068. Epub 2010 May 23.
PubMed 20546795Chan V, Ruel M, Elmistekawy E, Mesana TG. Determinants of left ventricular dysfunction after repair of chronic asymptomatic mitral regurgitation. Ann Thorac Surg. 2015 Jan;99(1):38-42. doi: 10.1016/j.athoracsur.2014.07.025. Epub 2014 Nov 6.
PubMed 25442982Chan V, Ruel M, Hynes M, Chaudry S, Mesana TG. Impact of mitral annular calcification on early and late outcomes following mitral valve repair of myxomatous degeneration. Interact Cardiovasc Thorac Surg. 2013 Jul;17(1):120-5. doi: 10.1093/icvts/ivt163. Epub 2013 Apr 14.
PubMed 23587525Chan V, Ruel M, Chaudry S, Lambert S, Mesana TG. Clinical and echocardiographic outcomes after repair of mitral valve bileaflet prolapse due to myxomatous disease. J Thorac Cardiovasc Surg. 2012 Apr;143(4 Suppl):S8-11. doi: 10.1016/j.jtcvs.2012.01.046. Epub 2012 Feb 4.
PubMed 22306213Castillo JG, Anyanwu AC, Fuster V, Adams DH. A near 100% repair rate for mitral valve prolapse is achievable in a reference center: implications for future guidelines. J Thorac Cardiovasc Surg. 2012 Aug;144(2):308-12. doi: 10.1016/j.jtcvs.2011.12.054. Epub 2012 Jun 12.
PubMed 22698565
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Mitral Valve Repair With Leaflet Resection Versus Leaflet Preservation on Functional Mitral Stenosis: The Canadian Mitral Research Alliance (CAMRA-1) Trial
- ClinicalTrials.gov ID
- NCT02552771
- Acronym / sponsor ID
- CAMRA / 15-162
- Conditions
- Mitral Valve Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation, London Health Sciences Centre
- Study start
- Jan 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 17 Sep 2015 (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.
Multicentre, double-armed, randomized controlled trial designed to compare mitral valve leaflet resection versus leaflet preservation with regards to the development of functional mitral stenosis following surgical repair of mitral valve prolapse. Patients will be randomized (1:1) to receive: (1) mitral valve repair with a leaflet resection or (2) mitral valve repair with leaflet preservation (using polytetrafluoroethylene neochordae), followed by echocardiographic and clinical assessment at 12-months following surgery.
Detailed description
Mitral valve repair has emerged as the preferred surgical treatment for mitral valve prolapse (MVP), a condition wherein the mitral valve does not close properly. One common strategy for mitral valve repair is leaflet resection, which involves removing part of one or both of the mitral leaflets that flop or bulge back (prolapse). Another strategy is leaflet preservation, which involves placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle). While both strategies are routinely used and lead to successful mitral valve repair, there is no clear evidence as to whether one strategy is better than the other in terms of long term outcome. The purpose of this study is to determine if one repair strategy (leaflet resection versus leaflet preservation) leads to better longer term patient outcomes. A total of 88 patients from 6 Canadian centres will be randomly assigned to one of the two strategies. The primary outcome will be functional mitral stenosis (MS) as assessed by 12-month mean mitral valve pressure gradient at peak exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitral repair with leaflet preservation | Active comparator | Procedure: Mitral repair with leaflet preservationPlacing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle). |
| Mitral repair with leaflet resection | Active comparator | Procedure: Mitral repair with leaflet resectionRemoval of one or both of the mitral leaflets that flop or bulge back. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with mitral regurgitation and mitral valve prolapse who are scheduled for elective mitral valve repair by an experienced mitral valve repair surgeon (>15 degenerative mitral valve repairs per year, with a repair rate>90%, and able to perform mitral repair with either a leaflet resection or leaflet preservation strategy).
- Planned mitral valve repair amenable to either a leaflet resection or leaflet preservation surgical repair strategy
Key exclusion criteria (6 listed)
- Patients with anterior leaflet or commissural prolapse
- Patients with endocarditis or rheumatic mitral valve disease
- Patients with mitral annular calcification extending beyond the circumference of one leaflet scallop
- Patients with significant LV dysfunction defined as a LVEF <40%
- Patients undergoing concomitant aortic valve surgery
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 |
|---|---|---|
| Mitral repair with leaflet preservationPlacing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle). | Procedure or surgery | Mitral repair with leaflet preservation |
| Mitral repair with leaflet resectionRemoving one or both of the mitral leaflets that flop or bulge back. | Procedure or surgery | Mitral repair with leaflet resection |
Primary outcome
Mean mitral valve gradient at peak exercise 12-months following repair
Time frame: 12 months following repair
5 secondary outcomes
Mitral valve area
Time frame: 12 months following repair
Age/Sex predicted metabolic equivalent score
Time frame: 12 months following repair
Mitral leaflet coaptation height
Time frame: 12 months following repair
6-minute walk test
Time frame: 12 months following repair
Composite MACE (major adverse cardiovascular event) end-point of recurrent MR ≥2+, death, or hospital re-admission for congestive heart failure within 12-months of surgery
Time frame: 12 months following repair
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Background: PubMed 15100753Theal M, Sleik K, Anand S, Yi Q, Yusuf S, Lonn E. Prevalence of mitral valve prolapse in ethnic groups. Can J Cardiol. 2004 Apr;20(5):511-5.
- Background: PubMed 10387935Freed LA, Levy D, Levine RA, Larson MG, Evans JC, Fuller DL, Lehman B, Benjamin EJ. Prevalence and clinical outcome of mitral-valve prolapse. N Engl J Med. 1999 Jul 1;341(1):1-7. doi: 10.1056/NEJM199907013410101.
- Background: PubMed 10467199Flack JM, Kvasnicka JH, Gardin JM, Gidding SS, Manolio TA, Jacobs DR Jr. Anthropometric and physiologic correlates of mitral valve prolapse in a biethnic cohort of young adults: the CARDIA study. Am Heart J. 1999 Sep;138(3 Pt 1):486-92. doi: 10.1016/s0002-8703(99)70151-1.
- Background: PubMed 8875918Ling LH, Enriquez-Sarano M, Seward JB, Tajik AJ, Schaff HV, Bailey KR, Frye RL. Clinical outcome of mitral regurgitation due to flail leaflet. N Engl J Med. 1996 Nov 7;335(19):1417-23. doi: 10.1056/NEJM199611073351902.
- Background: PubMed 15745978Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.
- Background: PubMed 19955526Verma S, Mesana TG. Mitral-valve repair for mitral-valve prolapse. N Engl J Med. 2009 Dec 3;361(23):2261-9. doi: 10.1056/NEJMct0806111. No abstract available.
- Background: PubMed 21911822Chan V, Malas T, Lapierre H, Boodhwani M, Lam BK, Rubens FD, Hendry PJ, Masters RG, Goldstein W, Mesana TG, Ruel M. Reoperation of left heart valve bioprostheses according to age at implantation. Circulation. 2011 Sep 13;124(11 Suppl):S75-80. doi: 10.1161/CIRCULATIONAHA.110.011973.
- Background: PubMed 19559823O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2--isolated valve surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S23-42. doi: 10.1016/j.athoracsur.2009.05.056.
- Background: PubMed 19559824Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3--valve plus coronary artery bypass grafting surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S43-62. doi: 10.1016/j.athoracsur.2009.05.055.
- Background: PubMed 14688722Ikonomidis JS, Kratz JM, Crumbley AJ 3rd, Stroud MR, Bradley SM, Sade RM, Crawford FA Jr. Twenty-year experience with the St Jude Medical mechanical valve prosthesis. J Thorac Cardiovasc Surg. 2003 Dec;126(6):2022-31. doi: 10.1016/j.jtcvs.2003.07.005.
- Background: PubMed 20546795Chan V, Jamieson WR, Lam BK, Ruel M, Ling H, Fradet G, Mesana TG. Influence of the On-X mechanical prosthesis on intermediate-term major thromboembolism and hemorrhage: a prospective multicenter study. J Thorac Cardiovasc Surg. 2010 Nov;140(5):1053-8.e2. doi: 10.1016/j.jtcvs.2009.10.068. Epub 2010 May 23.
- Background: PubMed 25442982Chan V, Ruel M, Elmistekawy E, Mesana TG. Determinants of left ventricular dysfunction after repair of chronic asymptomatic mitral regurgitation. Ann Thorac Surg. 2015 Jan;99(1):38-42. doi: 10.1016/j.athoracsur.2014.07.025. Epub 2014 Nov 6.
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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.
Vincent Chan, MD principal investigator
Ottawa Heart Institute Research Corporation
Subodh Verma, MD principal investigator
Unity Health Toronto
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral repair with leaflet preservation and Mitral repair with leaflet resection in people with Mitral Valve Prolapse, run by Unity Health Toronto at 6 sites in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Subodh Verma, MD (416-864-5997, vermasu@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean mitral valve gradient at peak exercise 12-months following repair (time frame: 12 months following repair). 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 NCT02552771, which also lists 32 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 7 Dec 2018.