Status:
UNKNOWN
Valvular Surgery: Minimally Invasive vs Conventional Sternotomy
Lead Sponsor:
University of Calgary
Conditions:
Minimally Invasive Cardiac Valvular Surgery
Eligibility:
All Genders
18+ years
Brief Summary
The conventional approach to heart valve operations is through a sternotomy. This involves a vertical incision in the sternum (breastbone) to gain access to the heart and its related structures. Post-...
Detailed Description
BACKGROUND \& RATIONALE: The conventional approach to heart valve operations is open-heart surgery. This involves a vertical incision along the sternum (breastbone) and splitting it in half to gain ac...
Eligibility Criteria
Inclusion
- Aged ≥ 18 years of age
- Undergoing non-emergent isolated aortic valve or mitral valve surgery
- Full median sternotomy approach or minimally invasive approach via right anterior/anterolateral mini-thoracotomy
- English speaking
- Geographically accessible; able and willing to attend follow-up visits
- Written informed consent
Exclusion
- Recent CPR
- Previous cardiac surgery
- Emergency surgery (operative intervention within 24 hours of assessment)
- Previous permanent pacemaker implantation
- Poor respiratory function - two or more measurements of FVC, FEV1, or PEF \<80% of predicted value based on age, gender, and height at baseline
- History of a bleeding disorder
- Excessively poor baseline health-related quality of life or physical functioning that would preclude a reasonable expected post-operative recovery to baseline
- Active significant systemic infection, (e.g. endocarditis, sepsis) a history of recurrent systemic infections; or have taken an antibiotic within 2 weeks prior to surgery
- Cognitive impairment (e.g., confusion, dementia, Alzheimer's disease, current substance abuse) that would preclude completion of survey questions or following instructions to complete pulmonary function testing
- History of malignancy within the past year (except for squamous or basal cell carcinoma of the skin that has been treated, with no evidence of recurrence)
- Recent history of significant drug or alcohol abuse
- Participation in another study that would affect the ability to obtain adequate follow-up
Key Trial Info
Start Date :
November 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 15 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04514315
Start Date
November 2 2020
End Date
November 15 2023
Last Update
June 1 2022
Active Locations (1)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9