Minimally Invasive Mitral Valve Replacement Versus Conventional Approach: Comparison of Early Postoperative Outcomes.

NCT ID: NCT05504109

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-04-01

Brief Summary

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The term minimally invasive mitral valve surgery has been reported (MIMVS) by American Heart Association and referred to a collection of new techniques. All of these new techniques aiming to reduce surgical trauma by minimizing surgical incision, modified perfusion methods and use of new instruments . The right anterior mini-thoracotomy is the most common approach, next to it the lower mini-sternotomy approach, then the parasternal incision or the left posterior thoracotomy approach .

Technically MIMVS is more complex, requires a special learning curve and associated with higher Incidence of neurological events, aortic dissection, groin complications and infection despite all these benefits . MIVS also has controversies among cardiac surgeons, because it makes the exposure worse and requires a more complex surgery, which may lead to a less satisfying effect

Detailed Description

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Conditions

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Minimally Invasive Mitral Valve Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

patients who will undergo mitral valve replacement through full sternotomy approach

Group Type ACTIVE_COMPARATOR

mitral valve replacement through full sternotomy approach.

Intervention Type PROCEDURE

compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach

Group B

patients who will undergo mitral valve replacement through right mini thoracotomy approach

Group Type ACTIVE_COMPARATOR

mitral valve replacement through right mini thoracotomy approach.

Intervention Type PROCEDURE

compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach

Interventions

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mitral valve replacement through full sternotomy approach.

compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach

Intervention Type PROCEDURE

mitral valve replacement through right mini thoracotomy approach.

compare between Minimally Invasive Mitral Valve Replacement and Conventional Approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with isolated rheumatic mitral valve disease in need for mitral valve replacement.

Exclusion Criteria

* Redo mitral valve replacement.
* Emergency mitral valve replacement (non-rheumatic cases).
* Patients who have combined other valve diseases e.g. (severe Aortic Regurgitation).
* Patients need Tricuspid valve repair or replacement.
* Severely calcified mitral valve disease (mitral annular calcification).
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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abdelhamed alaaeldin ali

Assistant lecture of cardiothoracic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Abdelhamed A haridi, assistant lecture

Role: CONTACT

01000565186

khaled m abdelaal, professor

Role: CONTACT

Facility Contacts

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Osama R ELsheref, professor

Role: primary

References

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Joshi P, Doshi C, Vinchurkar M, Thosani R, Sagar P, Mahajan V. Minimally invasive combined aortic and mitral valve replacement. Heart Lung Circ. 2011 Apr;20(4):231-3. doi: 10.1016/j.hlc.2010.10.072. Epub 2010 Dec 10.

Reference Type BACKGROUND
PMID: 21146456 (View on PubMed)

Schmitto JD, Mokashi SA, Cohn LH. Minimally-invasive valve surgery. J Am Coll Cardiol. 2010 Aug 3;56(6):455-62. doi: 10.1016/j.jacc.2010.03.053.

Reference Type BACKGROUND
PMID: 20670754 (View on PubMed)

Falk V, Cheng DC, Martin J, Diegeler A, Folliguet TA, Nifong LW, Perier P, Raanani E, Smith JM, Seeburger J. Minimally invasive versus open mitral valve surgery: a consensus statement of the international society of minimally invasive coronary surgery (ISMICS) 2010. Innovations (Phila). 2011 Mar;6(2):66-76. doi: 10.1097/IMI.0b013e318216be5c.

Reference Type BACKGROUND
PMID: 22437890 (View on PubMed)

Vollroth M, Seeburger J, Garbade J, Borger MA, Misfeld M, Mohr FW. Conversion rate and contraindications for minimally invasive mitral valve surgery. Ann Cardiothorac Surg. 2013 Nov;2(6):853-4. doi: 10.3978/j.issn.2225-319X.2013.10.15. No abstract available.

Reference Type BACKGROUND
PMID: 24349996 (View on PubMed)

Other Identifiers

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Soh-Med-22-08-12

Identifier Type: -

Identifier Source: org_study_id

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