Barlow's DiseaseNCT04002648

Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?

An observational study of Barlow's Disease and Prolapse; Mitral, run by Ospedale San Raffaele.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Barlow's Disease, Prolapse; Mitral
What is being tested?: Right minithoracotomy and Sternotomy
Type of treatment: Surgery or procedure
How many people: 208 participants
Where: No sites listed yet
Study dates: 1 Dec 2016to 1 Dec 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Patients with severe MR due to the prolapse of both leaflets in the context of Barlow's disease submitted to EE repair via a video-assisted right minithoracotomy (minithoracotomy group) and patients with Barlow's disease treated with surgical mitral repair with the EE technique through a conventional median sternotomy (sternotomy group). The diagnosis of Barlow's disease was made during a preoperative transoesophageal echocardiographic (TEE) examination and confirmed by the surgeon's direct assessment of the valve. All patients had excessive leaflet tissue, annular dilatation and bileaflet prolapse. Cases with a forme fruste of Barlow's disease were excluded.

Who may be able to join

Patients treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011

Who cannot join

Age inferior to 18 years

About this study

The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.

Conditions: Barlow's Disease, Prolapse; Mitral
Being tested: Right minithoracotomy, Sternotomy
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.

Right minithoracotomyProcedure or surgery
Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
SternotomyProcedure or surgery
Longitudinal resection of the sternum

Study groups in NCT04002648
Study group	Role	What they receive
MT-Right		Not described Receives: Procedure: Right minithoracotomy
Sternotomy		Not described Receives: Procedure: Sternotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiac Death
The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk
Measured: 12 years
Severe MR
The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk
Measured: 12 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20161 Dec 2016

First posted28 Jun 2019
Study start1 Dec 2016
Primary completion1 Dec 2016
Study completion1 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Barlow's DiseaseStudies 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: Case only
Time perspective: Retrospective
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04002648
Sponsor's protocol ID: MICETE-BBL
Status last verified: Jul 2020
First submitted: 27 Jun 2019
Last updated: 7 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Vahanian 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 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?
ClinicalTrials.gov ID: NCT04002648
Acronym / sponsor ID: MICETE-BBL
Conditions: Barlow's Disease, Prolapse; Mitral
Study type: Observational
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: Ospedale San RaffaeleUniversity, hospital or other
Study start: 1 Dec 2016 (actual)
Primary completion: 1 Dec 2016 (actual)
Study completion: 1 Dec 2016 (actual)
First posted: 28 Jun 2019 (actual)
Results: Posted 19 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
MT-Right	–	Procedure: Right minithoracotomy
Sternotomy	–	Procedure: Sternotomy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with severe MR due to the prolapse of both leaflets in the context of Barlow's disease submitted to EE repair via a video-assisted right minithoracotomy (minithoracotomy group) and patients with Barlow's disease treated with surgical mitral repair with the EE technique through a conventional median sternotomy (sternotomy group). The diagnosis of Barlow's disease was made during a preoperative transoesophageal echocardiographic (TEE) examination and confirmed by the surgeon's direct assessment of the valve. All patients had excessive leaflet tissue, annular dilatation and bileaflet prolapse. Cases with a forme fruste of Barlow's disease were excluded.

Key inclusion criteria (1 listed)

Patients treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011

Key exclusion criteria (1 listed)

Age inferior to 18 years

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
Right minithoracotomyIncision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Procedure or surgery	MT-Right
SternotomyLongitudinal resection of the sternum	Procedure or surgery	Sternotomy

Primary outcome

Cardiac Death
Time frame: 12 years
The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk
Severe MR
Time frame: 12 years
The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk

Results and safety

Results posted to the registry on 19 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MT-Right	104	102
Sternotomy	104	104

Primary outcome: Cardiac Death

Time frame: 12 years. Number (95% Confidence Interval). Unit: percentage of participants with event

Measure	MT-Right n = 102	Sternotomy n = 104
Value	3.9 (0.6 to 13.3)	3.8 (1.3 to 8.8)

Primary outcome: Severe MR

Time frame: 12 years. Number (95% Confidence Interval). Unit: percentage of participants with event

Measure	MT-Right n = 102	Sternotomy n = 104
Value	5.8 (1.8 to 13.4)	11.4 (5.9 to 18.8)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MT-Right	11 of 102 (10.8%)	0 of 102 (0%)	Not reported
Sternotomy	10 of 104 (9.6%)	0 of 104 (0%)	Not reported

Limitations and caveats (from the sponsor): Limitations due to retrospective design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Barlow's Disease and Prolapse; Mitral, run by Ospedale San Raffaele.

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: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cardiac Death (time frame: 12 years). The study lists 2 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 NCT04002648, which also lists 1 linked publication.

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 Aug 2020.