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?

• Sponsor: Ospedale San Raffaele (Other)
• Overall Status: Completed
• CT.gov ID: NCT04002648
• Collaborator: (none)
• Enrollment: 208

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Barlow's Disease; Prolapse; Mitral	Procedure: Right minithoracotomy; Procedure: Sternotomy

Study Design

• Study Type: Observational
• Actual Enrollment: 208 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• 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?
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
MT-Right	Procedure: Right minithoracotomy; Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
Sternotomy	Procedure: Sternotomy; Longitudinal resection of the sternum

Outcome Measures

Primary Outcome Measures

1. Cardiac Death [12 years]

   The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk

2. Severe MR [12 years]

   The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

Age inferior to 18 years

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ospedale San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers 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.

• Responsible Party: Michele De Bonis, Principal Investigator, Ospedale San Raffaele
• ClinicalTrials.gov Identifier: NCT04002648
• Other Study ID Numbers: MICETE-BBL
• First Posted: Jun 28, 2019
• Last Update Posted: Aug 7, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mitral Valve Insufficiency; Prolapse

Study Results

Participant Flow

Arm/Group Title	MT-Right	Sternotomy
Arm/Group Description	Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Sternotomy: Longitudinal resection of the sternum
Period Title: Overall Study
STARTED	104	104
COMPLETED	102	104
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	MT-Right	Sternotomy	Total
Arm/Group Description	Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Sternotomy: Longitudinal resection of the sternum	Total of all reporting groups
Overall Participants	104	104	208
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36 (8)	51 (13)	43.5 (10.5)
Sex: Female, Male (Count of Participants)
Female	68 65.4%	38 36.5%	106 51%
Male	34 32.7%	66 63.5%	100 48.1%
Region of Enrollment (participants) [Number]
Italy	102 98.1%	104 100%	206 99%

Outcome Measures

1. Primary Outcome

Title	Cardiac Death
Description	The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk
Time Frame	12 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MT-Right	Sternotomy
Arm/Group Description	Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Sternotomy: Longitudinal resection of the sternum
Measure Participants	102	104
Number (95% Confidence Interval) [percentage of participants with event]	3.9 3.8%	3.8 3.7%

2. Primary Outcome

Title	Severe MR
Description	The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk
Time Frame	12 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MT-Right	Sternotomy
Arm/Group Description	Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space	Sternotomy: Longitudinal resection of the sternum
Measure Participants	102	104
Number (95% Confidence Interval) [percentage of participants with event]	5.8 5.6%	11.4 11%

Adverse Events

Arm/Group Title	MT-Right		Sternotomy
Arm/Group Description	Right minithoracotomy: Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space		Sternotomy: Longitudinal resection of the sternum
All Cause Mortality
	MT-Right		Sternotomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MT-Right		Sternotomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/102 (10.8%)		10/104 (9.6%)
Surgical and medical procedures
Reoperation	11/102 (10.8%)	11	10/104 (9.6%)	10
Other (Not Including Serious) Adverse Events
	MT-Right		Sternotomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/102 (0%)		0/104 (0%)

Limitations/Caveats

Limitations due to retrospective design.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.