Minimally Invasive Cardiac Valvular SurgeryNCT04514315
Valvular Surgery: Minimally Invasive vs Conventional Sternotomy
An observational study of Minimally Invasive Cardiac Valvular Surgery, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimally Invasive Cardiac Valvular Surgery
- What is being tested?
- Minimally invasive cardiac valvular surgery and Conventional cardiac valvular surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 2 Nov 2020to 15 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 receiving a heart valve operation through either a minimally invasive approach via right mini-thoracotomy or conventional open-heart surgery via full median sternotomy at the Calgary Foothills Medical Centre.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Sean Kang, BSc, MSc, 4032106209, sekang@ucalgary.ca
Darlene Ramadan, BN, CCRP, 4032107356, ramadan@ucalgary.ca
About this study
Official title: Comparison of Outcomes for Minimally Invasive and Conventional Cardiac Valvular Surgery: A Prospective Cohort Study
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.
Read the 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 access to the heart and its related structures. Open-heart surgery provides maximal exposure of the heart to the surgeon and results in good clinical outcome. However, post-operative recovery after open-heart surgery can take anywhere from 6 weeks to 3 months due to the time required for the sternum to fully heal. During this time patients can experience considerable pain and reduced mobility which have a significant negative impact on quality of life and productivity. Patients are also prone to major sternal complications such as wound opening and sternal infection, all of which may compromise respiratory function and overall recovery.
Minimally invasive valve surgery is a less invasive alternative to 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. This approach has been increasingly favoured and adopted by patients and physicians due to the benefits of avoiding sternal complications associated with open-heart surgery as well as cosmetic benefits. Despite these benefits, it is still unclear whether minimally invasive valve surgery provides better clinical outcomes and quality of life compared to conventional open-heart surgery.
RESEARCH QUESTION \& OBJECTIVES: The aim of this observational research study is to assess the post-operative functional recovery and clinical outcomes of minimally invasive valve surgery via right mini-thoracotomy and conventional surgery via full median sternotomy. The objectives of this study are:
- To assess post-operative functional recovery in minimally invasive and conventional valve surgery patients by assessing recovery of respiratory function, pain, physical function, and quality of life back to baseline.
- To assess post-operative complications in minimally invasive and conventional valve surgery patients by assessing the incidence of early mortality, stroke, post-operative atrial fibrillation, permanent pacemaker implantation, paravalvular leak, pulmonary complication, wound infection, acute kidney injury, and reoperation.
- To assess post-operative valve function in minimally invasive and conventional valve surgery patients by assessing valve gradients and degree of leakage.
- To assess perioperative support for minimally invasive and conventional valve surgery patients by assessing ventilation time, cardiopulmonary bypass time, cross-clamp time, amount of blood transfusion, analgesic requirements, and length of ICU and hospital stay.
METHODS: The proposed clinical study is a single-center, prospective cohort study. All participants will undergo data collection procedures over a 12-month follow-up period. Specifically, data regarding demographics, medical history, and medications will be collected, and spirometry testing with a hand-held spirometer will be performed at baseline. Patients will be evaluated in hospital on post-op Day 3 and at discharge for pain, analgesic/antibiotic use, wound healing, any clinical events, quality of life (EQ-5D), and spirometry. Subsequently, patients will return to hospital for follow-up visits post operatively for physical examination, interview, additional quality of life questionnaires (EQ-5D, KCCQ-23, Health Assessment Questionnaire), and spirometry testing at 2 weeks, 6 weeks, and 3 months after surgery, with a final phone interview at 12 months.
- Being tested
- Minimally invasive cardiac valvular surgery, Conventional cardiac valvular surgery
- Keywords
- Minimally Invasive Valvular Surgery, Cardiac Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive cardiac valvular surgeryProcedure or surgery
Minimally invasive valve surgery via right mini-thoracotomy.
Conventional cardiac valvular surgeryProcedure or surgery
Conventional valve surgery via full median sternotomy
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive aortic valve surgery | Patients undergoing minimally invasive aortic valve surgery Receives: Procedure: Minimally invasive cardiac valvular surgery | |
| Minimally invasive mitral valve surgery | Patients undergoing minimally invasive mitral valve surgery Receives: Procedure: Minimally invasive cardiac valvular surgery | |
| Conventional aortic valve surgery | Patients undergoing conventional aortic valve surgery Receives: Procedure: Conventional cardiac valvular surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative recovery of respiratory function (FVC)
Rate of post-operative recovery of respiratory function to baseline as measured by forced vital capacity (FVC) in litres from baseline to 12 months post-surgery. This measurement will be obtained by performing a pulmonary function testing (PFT) using a hand-held electronic spirometer.
Measured: 12 months
Post-operative recovery of respiratory function (FEV1)
Rate of post-operative recovery of respiratory function to baseline as measured by forced expiratory volume (FEV1) in litres from baseline to 12 months post-surgery. This measurement will be obtained by performing a pulmonary function testing (PFT) using a hand-held electronic spirometer.
Measured: 12 months
Post-operative recovery of respiratory function (PEF)
Rate of post-operative recovery of respiratory function to baseline as measured by peak expiratory flow (PEF) in litres/minute from baseline to 12 months post-surgery. This measurement will be obtained by performing a pulmonary function testing (PFT) using a hand-held electronic spirometer.
Measured: 12 months
Post-operative pain
Severity of post-operative pain from baseline to 12 months post-surgery. Pain will be measured using an 11-point numeric rating scale (0 to 10). The scales will be associated with descriptors 0=none, 10=worst. Patients will be assessed for pain at the surgical incision sites (ie. sternum/rib/groin), chest, breast, neck, back, arms, and legs - areas of the body which may be affected by sternotomy or minimally invasive surgery. As pain might also interfere with function and mobility, participants will be asked to what degree the pain associated with their surgical incisions interfere with their ability to breath, cough, walk, and sleep.
Measured: 12 months
Post-operative analgesic use
Type (narcotics vs non-narcotics) and amount of analgesic use in milligrams will be collected from baseline to 12 months post-surgery as indicators of pain.
Measured: 12 months
Post-operative recovery of health-related quality of life (EQ5D)
Rate of post-operative recovery of health-related quality of life (HRQL) as determined by EQ5D questionnaire from baseline to 12 months post-surgery. The EQ-5D is a validated questionnaire which consists of two components: a self-reported measure of HRQL and a valuation of health states relative to full-health. The health status description component measures HRQL according to a five dimensional classification system. The dimensions are mobility, self-care, usual activities, pain and mood. There are five levels in each dimension resulting in 3125 theoretically possible health states which can be converted to a single index score.
Measured: 12 months
Post-operative recovery of health-related quality of life (EQ VAS)
Rate of post-operative recovery of health-related quality of life (HRQL) as determined by EQ VAS (visual analogue scale) from baseline to 12 months post-surgery. The EQ-5D is a validated questionnaire which consists of a component using a visual analogue scale to determine self-reported measures of HRQL. The self-reported measure involves rating one's own health on a scale of 0-100 using a visual analogue scale where 100 represents the best health one can imagine and 0 representing the worst health.
Measured: 12 months
Post-operative recovery of health-related quality of life (KCCQ-12)
Rate of post-operative recovery of health-related quality of life (HRQL) as determined by KCCQ-12 from baseline to 12 months post-surgery. The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a validated self-administered questionnaire that independently measures the patient's perception of their health status using 12 items. The KCCQ-12 quantifies 4 distinct domains: symptom frequency, physical function, social limitation, and quality of life, from which an overall summary score can be derived. Scores are generated from each domain and scaled from 0 to 100 - 0 denoting the worst and 100 the best possible status.
Measured: 12 months
Post-operative recovery of health-related quality of life (HAQ)
Rate of post-operative recovery of health-related quality of life (HRQL) as determined by HAQ from baseline to 12 months post-surgery. The Health Assessment Questionnaire (HAQ) is a validated index used to identify difficulty in performing activities of daily living. Questions require that participants identify how much difficulty they have had managing a variety of activities of daily living such as: dressing \& grooming, arising, eating, walking, hygiene, reach, grip, and activities. This questionnaire focuses on both fine and gross motor skills which are greatly affected in heart surgery patients due to post-operative pain and discomfort. The highest score (indicating the greatest disability) within each of the eight dimensions is used to calculate the 'disability index'.
Measured: 12 months
Post-operative complications
Post-operative complications including: early mortality, stroke, post-operative atrial fibrillation, permanent pacemaker implantation, paravalvular leak, pulmonary complication, wound infection, acute kidney injury, and reoperation from baseline to 12 months post-surgery.
Measured: 12 months
Post-operative valve function
Post-operative valve function as determined by valve gradients and degree of leakage from baseline to 12 months post-surgery.
Measured: 12 months
Perioperative outcomes
Perioperative outcomes including: postoperative ventilation time, cardiopulmonary bypass time, cross-clamp time, amount of blood transfusion, returns to operating room, and length of ICU and hospital stay from baseline to discharge from hospital.
Measured: Up to 12 months
Health services resource usage
Health services resource usage using the items examined for the perioperative outcomes (ie. ventilation time, length of ICU and hospital stay, etc…) as well as any additional health care services after discharge ie. visits to health care provider, home care services, hospital admissions, and emergency visits from baseline to 12 months post-surgery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start2 Nov 2020
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Cardiac Valvular SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Kent, University of Calgary
- Investigators
- William Kent, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514315
- Sponsor's protocol ID
- REB20-0859
- Status last verified
- May 2022
- First submitted
- 15 Jul 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes for Minimally Invasive and Conventional Cardiac Valvular Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04514315
- Acronym / sponsor ID
- REB20-0859
- Keywords
- Minimally Invasive Valvular Surgery, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 access to the heart and its related structures. Open-heart surgery provides maximal exposure of the heart to the surgeon and results in good clinical outcome. However, post-operative recovery after open-heart surgery can take anywhere from 6 weeks to 3 months due to the time required for the sternum to fully heal. During this time patients can experience considerable pain and reduced mobility which have a significant negative impact on quality of life and productivity. Patients are also prone to major sternal complications such as wound opening and sternal infection, all of which may compromise respiratory function and overall recovery.
Minimally invasive valve surgery is a less invasive alternative to 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. This approach has been increasingly favoured and adopted by patients and physicians due to the benefits of avoiding sternal complications associated with open-heart surgery as well as cosmetic benefits. Despite these benefits, it is still unclear whether minimally invasive valve surgery provides better clinical outcomes and quality of life compared to conventional open-heart surgery.
RESEARCH QUESTION \& OBJECTIVES: The aim of this observational research study is to assess the post-operative functional recovery and clinical outcomes of minimally invasive valve surgery via right mini-thoracotomy and conventional surgery via full median sternotomy. The objectives of this study are:
- To assess post-operative functional recovery in minimally invasive and conventional valve surgery patients by assessing recovery of respiratory function, pain, physical function, and quality of life back to baseline.
- To assess post-operative complications in minimally invasive and conventional valve surgery patients by assessing the incidence of early mortality, stroke, post-operative atrial fibrillation, permanent pacemaker implantation, paravalvular leak, pulmonary complication, wound infection, acute kidney injury, and reoperation.
- To assess post-operative valve function in minimally invasive and conventional valve surgery patients by assessing valve gradients and degree of leakage.
- To assess perioperative support for minimally invasive and conventional valve surgery patients by assessing ventilation time, cardiopulmonary bypass time, cross-clamp time, amount of blood transfusion, analgesic requirements, and length of ICU and hospital stay.
METHODS: The proposed clinical study is a single-center, prospective cohort study. All participants will undergo data collection procedures over a 12-month follow-up period. Specifically, data regarding demographics, medical history, and medications will be collected, and spirometry testing with a hand-held spirometer will be performed at baseline. Patients will be evaluated in hospital on post-op Day 3 and at discharge for pain, analgesic/antibiotic use, wound healing, any clinical events, quality of life (EQ-5D), and spirometry. Subsequently, patients will return to hospital for follow-up visits post operatively for physical examination, interview, additional quality of life questionnaires (EQ-5D, KCCQ-23, Health Assessment Questionnaire), and spirometry testing at 2 weeks, 6 weeks, and 3 months after surgery, with a final phone interview at 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive aortic valve surgery | – | Procedure: Minimally invasive cardiac valvular surgeryPatients undergoing minimally invasive aortic valve surgery |
| Minimally invasive mitral valve surgery | – | Procedure: Minimally invasive cardiac valvular surgeryPatients undergoing minimally invasive mitral valve surgery |
| Conventional aortic valve surgery | – | Procedure: Conventional cardiac valvular surgeryPatients undergoing conventional aortic valve surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving a heart valve operation through either a minimally invasive approach via right mini-thoracotomy or conventional open-heart surgery via full median sternotomy at the Calgary Foothills Medical Centre.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Minimally invasive cardiac valvular surgeryMinimally invasive valve surgery via right mini-thoracotomy. | Procedure or surgery | Minimally invasive aortic valve surgery, Minimally invasive mitral valve surgery |
| Conventional cardiac valvular surgeryConventional valve surgery via full median sternotomy | Procedure or surgery | Conventional aortic valve surgery |
Primary outcome
Post-operative recovery of respiratory function (FVC)
Time frame: 12 months
Rate of post-operative recovery of respiratory function to baseline as measured by forced vital capacity (FVC) in litres from baseline to 12 months post-surgery. This measurement will be obtained by performing a pulmonary function testing (PFT) using a hand-held electronic spirometer.
Post-operative recovery of respiratory function (FEV1)
Time frame: 12 months
Rate of post-operative recovery of respiratory function to baseline as measured by forced expiratory volume (FEV1) in litres from baseline to 12 months post-surgery. This measurement will be obtained by performing a pulmonary function testing (PFT) using a hand-held electronic spirometer.
Post-operative recovery of respiratory function (PEF)
Time frame: 12 months
Rate of post-operative recovery of respiratory function to baseline as measured by peak expiratory flow (PEF) in litres/minute from baseline to 12 months post-surgery. This measurement will be obtained by performing a pulmonary function testing (PFT) using a hand-held electronic spirometer.
Post-operative pain
Time frame: 12 months
Severity of post-operative pain from baseline to 12 months post-surgery. Pain will be measured using an 11-point numeric rating scale (0 to 10). The scales will be associated with descriptors 0=none, 10=worst. Patients will be assessed for pain at the surgical incision sites (ie. sternum/rib/groin), chest, breast, neck, back, arms, and legs - areas of the body which may be affected by sternotomy or minimally invasive surgery. As pain might also interfere with function and mobility, participants will be asked to what degree the pain associated with their surgical incisions interfere with their ability to breath, cough, walk, and sleep.
Post-operative analgesic use
Time frame: 12 months
Type (narcotics vs non-narcotics) and amount of analgesic use in milligrams will be collected from baseline to 12 months post-surgery as indicators of pain.
Post-operative recovery of health-related quality of life (EQ5D)
Time frame: 12 months
Rate of post-operative recovery of health-related quality of life (HRQL) as determined by EQ5D questionnaire from baseline to 12 months post-surgery. The EQ-5D is a validated questionnaire which consists of two components: a self-reported measure of HRQL and a valuation of health states relative to full-health. The health status description component measures HRQL according to a five dimensional classification system. The dimensions are mobility, self-care, usual activities, pain and mood. There are five levels in each dimension resulting in 3125 theoretically possible health states which can be converted to a single index score.
Post-operative recovery of health-related quality of life (EQ VAS)
Time frame: 12 months
Rate of post-operative recovery of health-related quality of life (HRQL) as determined by EQ VAS (visual analogue scale) from baseline to 12 months post-surgery. The EQ-5D is a validated questionnaire which consists of a component using a visual analogue scale to determine self-reported measures of HRQL. The self-reported measure involves rating one's own health on a scale of 0-100 using a visual analogue scale where 100 represents the best health one can imagine and 0 representing the worst health.
Post-operative recovery of health-related quality of life (KCCQ-12)
Time frame: 12 months
Rate of post-operative recovery of health-related quality of life (HRQL) as determined by KCCQ-12 from baseline to 12 months post-surgery. The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a validated self-administered questionnaire that independently measures the patient's perception of their health status using 12 items. The KCCQ-12 quantifies 4 distinct domains: symptom frequency, physical function, social limitation, and quality of life, from which an overall summary score can be derived. Scores are generated from each domain and scaled from 0 to 100 - 0 denoting the worst and 100 the best possible status.
Post-operative recovery of health-related quality of life (HAQ)
Time frame: 12 months
Rate of post-operative recovery of health-related quality of life (HRQL) as determined by HAQ from baseline to 12 months post-surgery. The Health Assessment Questionnaire (HAQ) is a validated index used to identify difficulty in performing activities of daily living. Questions require that participants identify how much difficulty they have had managing a variety of activities of daily living such as: dressing \& grooming, arising, eating, walking, hygiene, reach, grip, and activities. This questionnaire focuses on both fine and gross motor skills which are greatly affected in heart surgery patients due to post-operative pain and discomfort. The highest score (indicating the greatest disability) within each of the eight dimensions is used to calculate the 'disability index'.
Post-operative complications
Time frame: 12 months
Post-operative complications including: early mortality, stroke, post-operative atrial fibrillation, permanent pacemaker implantation, paravalvular leak, pulmonary complication, wound infection, acute kidney injury, and reoperation from baseline to 12 months post-surgery.
Post-operative valve function
Time frame: 12 months
Post-operative valve function as determined by valve gradients and degree of leakage from baseline to 12 months post-surgery.
Perioperative outcomes
Time frame: Up to 12 months
Perioperative outcomes including: postoperative ventilation time, cardiopulmonary bypass time, cross-clamp time, amount of blood transfusion, returns to operating room, and length of ICU and hospital stay from baseline to discharge from hospital.
Health services resource usage
Time frame: 12 months
Health services resource usage using the items examined for the perioperative outcomes (ie. ventilation time, length of ICU and hospital stay, etc…) as well as any additional health care services after discharge ie. visits to health care provider, home care services, hospital admissions, and emergency visits from baseline to 12 months post-surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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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.
William Kent, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimally Invasive Cardiac Valvular Surgery, run by University of Calgary at 1 site in Canada.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Kent, MD (403-944-5480, william.kent@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative recovery of respiratory function (FVC) (time frame: 12 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2022.