Recruiting

Minimally Invasive & Conventional

Sponsor:

University of Calgary

Code:

NCT04514315

Conditions

Minimally Invasive Cardiac Valvular Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Minimally invasive cardiac valvular surgery

Conventional cardiac valvular surgery

Study Details

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-operative recovery after sternotomy can take anywhere from 6 weeks to 3 months due to the time required for the sternum to fully heal.

Minimally invasive valve surgery is a less invasive alternative to conventional open-heart surgery. At the Foothills Medical Centre, surgeons perform minimally invasive valve surgery through a technique called right mini-thoracotomy. This involves a small incision on the right upper chest and leaves the sternum fully intact. It is unclear whether minimally invasive valve surgery provides better clinical outcomes and quality of life compared to conventional open heart surgery.

The purpose of this research study is to compare the clinical outcomes of minimally invasive valve surgery via right mini-thoracotomy to conventional surgery via open-heart surgery. The results of this study will inform surgeons of the benefits and disadvantages of minimally invasive surgery compared to the current standards. This will help in developing better treatment strategies for patients requiring valve therapy.

Conditions

Minimally Invasive Cardiac Valvular Surgery

Study ID

NCT04514315

Start date

Nov 2, 2020

Status verified date

May, 2022

Completion date

Nov 15, 2023

Anticipated

Primary completion date

Nov 15, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Minimally invasive aortic valve surgery

Patients undergoing minimally invasive aortic valve surgery

Minimally invasive mitral valve surgery

Patients undergoing minimally invasive mitral valve surgery

Conventional aortic valve surgery

Patients undergoing conventional aortic valve surgery

Interventions

Minimally invasive cardiac valvular surgery

Minimally invasive valve surgery via right mini-thoracotomy.

Conventional cardiac valvular surgery

Conventional valve surgery via full median sternotomy

Primary outcome measure

  • Post-operative recovery of respiratory function (FVC) [ Time Frame: 12 months ]
  • Post-operative recovery of respiratory function (FEV1) [ Time Frame: 12 months ]
  • Post-operative recovery of respiratory function (PEF) [ Time Frame: 12 months ]
  • Post-operative pain [ Time Frame: 12 months ]
  • Post-operative analgesic use [ Time Frame: 12 months ]
  • Post-operative recovery of health-related quality of life (EQ5D) [ Time Frame: 12 months ]
  • Post-operative recovery of health-related quality of life (EQ VAS) [ Time Frame: 12 months ]
  • Post-operative recovery of health-related quality of life (KCCQ-12) [ Time Frame: 12 months ]
  • Post-operative recovery of health-related quality of life (HAQ) [ Time Frame: 12 months ]
  • Post-operative complications [ Time Frame: 12 months ]
  • Post-operative valve function [ Time Frame: 12 months ]
  • Perioperative outcomes [ Time Frame: Up to 12 months ]
  • Health services resource usage [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

William Kent, MD

403-944-5480william.kent@albertahealthservices.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Sean Kang, BSc, MSc

4032106209sekang@ucalgary.ca

Darlene Ramadan, BN, CCRP

4032107356ramadan@ucalgary.ca

Principal Investigator:

William Kent, MD

More Information

Sponsor

University of Calgary

Last update posted

Jun 1, 2022

Last verified

May, 2022

Keywords

  • Minimally Invasive Valvular Surgery
  • Cardiac Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-06-01.