Aortic Valve StenosisPASTANCT04632095
Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement
A study testing Aortic valve replacement due to sternotomy and Aortic valve replacement due to parasternal right anterior mini-thoracotomy in people with Aortic Valve Stenosis, run by Jena University Hospital at 1 site in Germany.
Trial summary
Prospective randomized study comparing aortic valve replacement using parasternal or sternotomy access with regard to quality of life and systemic inflammatory reaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Aortic valve replacement due to sternotomy and Aortic valve replacement due to parasternal right anterior mini-thoracotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 16 Mar 2021to 15 Nov 2022
- Phase
- Interventional
- 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
Who may be able to join
- Indication for elective isolated aortic valve replacement
- Anatomical suitability for both sternotomy and parasternal access
- Age ≥ 18
- Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Who cannot join
- Planned simultaneous cardiac surgery interventions (Mitral valve surgery, tricuspid valve surgery, CABG, Pacemaker or defibrillator implantation, Pulmonalvenenisolation, Maze, closure of left atrial appendage , patent foramen ovale or atrial septal defect closure)
- Acute myocardial infarction within 4 weeks, coronary heart disease
- Acute endocarditis
- TIA or stroke within 6 months prior to the procedure
- Pregnant or breast-feeding women
- Renal failure requiring dialysis
Show all 10Show fewer
- Ejection fraction ≤ 30%
- Re-operation
- Disease with a life expectancy < 2 years
- Therapy with glucocorticoids or immunosuppressants
Trial locations and contacts
1 site in 1 country.
About this study
Prospective randomized study comparing aortic valve replacement using parasternal or sternotomy access with regard to quality of life and systemic inflammatory reaction.
Read the detailed description
The classic surgical treatment of aortic stenosis is valve replacement through complete midline opening of the breastbone (median sternotomy) and use of cardiopulmonary bypass (CPB). Risks of this procedure are related to both the surgical approach and the use of CPB. Using minimally invasive approaches in non-cardiac patients (e.g laparoscopy) resulted in reduced postoperative inflammatory response when compared to patients undergoing the same procedures carried out with a conventional "open" technique. Minimally invasive surgical approaches in which the sternum is partially opened (partial sternotomy) or not opened at all (parasternal access) have thus far shown similar procedure related mortality and lower incidence of perioperative complications, despite longer CPB times. Our single center experience thus far suggests superiority of parasternal aortic valve replacement (O/E ratio of 0.19 over the last 2 years), as well as a reduced postoperative inflammatory response (as measured by lower CRP (C reactive protein ) levels taken 6 hours post-surgery). However, these data have several confounders and there is currently no prospective randomized trial addressing this topic. We therefore conduct a randomized comparison of parasternal versus classic sternotomy aortic valve replacement. Based on our previous experience, we expect very low mortality risk in both groups (expected ≤ 1%). The primary endpoint is therefore quality of life assessed using the SF-36 (Short Form) health survey questionnaire. This approach is similar to other current large multicenter trials. In order to address the impact of reduced surgical trauma on inflammatory response; we will quantify an established panel of inflammatory markers (PCT, CRP, interleukin 6) and use bio-banking to allow for further in depth analysis later on. Standardized clinical endpoints will be analyzed as additional secondary parameters. Power analysis determined a number of 50 patients allocated to 2 equal groups to achieve a power of 80%. The parasternal approach is expected to be superior when compared to sternotomy in both the primary and some, if not most, secondary endpoints. We expect our study to become an important milestone for decision-making in the treatment of aortic stenosis. Patients currently fear sternotomy, but the less invasive transcatheter valve implantation appears to be limited by inferior long-term outcome. The parasternal, sternotomy-sparing, classic aortic valve replacement is therefore an attractive therapeutic alternative. Our investigation in relation to systemic inflammatory response will further shed light on the underlying mechanisms explaining differences in clinical outcomes.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Aortic valve replacement due to sternotomy, Aortic valve replacement due to parasternal right anterior mini-thoracotomy
- Keywords
- Aortic Valve Stenosis, minimally invasive surgery, parasternal approach, quality of life, aortic valve replacement, inflammatory markers
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve replacement due to sternotomyProcedure or surgery
conventional surgery of aortic stenosis
Aortic valve replacement due to parasternal right anterior mini-thoracotomyProcedure or surgery
surgery of aortic stenosis in minimally invasive technique
| Study group | Role | What they receive |
|---|---|---|
| Sternotomy AVR | Active comparator | Aortic valve replacement due to sternotomy Receives: Procedure: Aortic valve replacement due to sternotomy |
| Mini AVR | Active comparator | Aortic valve replacement due to parasternal right anterior mini-thoracotomy Receives: Procedure: Aortic valve replacement due to parasternal right anterior mini-thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life - physical function
Comparison of the physical quality of life between the two groups 30 days after surgery using the physical function score of the 36-Item Short Form Health Survey (SF-36). The physical function score is a scale from 0 (poor physical function) to 100 (excellent physical function, with an average score of 50. It includes items that assess physical functioning, bodily pain, physical role functioning, vitality, and generaly health perceptions.
Measured: 30 days after surgery
Secondary outcomes (15)
Inflammatory markers: Procalcitonin, C-reactive protein, Interleukin-6
Plasma profiles of inflammatory biomarkers at defined time points in the course of the surgical intervention (baseline, before introduction of CPB, 1 hour after introduction of CPB, disconnection of CPB, 6, 24 and 48 hours post-surgery)
Measured: During the first 48 hours after surgery
Quality of Life - mental function
Comparison of the mental quality of life between the two Groups 30 days after surgery using the mental component score of the 36-Item Short Form Health Survey (SF-36). The mental function score is a scale from 0 (poor mental quality of life) to 100 (excellent mental quality of life), with an average score of 50. It includes items that assess vitality, general health perceptions, emotional role functioning, social role functioning, and mental health.
Measured: 30 days after surgery
Duration of the Operation
Comparison of the average duration of operation between the groups
Measured: During the aortic valve replacement surgery
Duration of cardiopulmonary bypass
Comparison of the average duration of cardiopulmonary bypass between the groups
Measured: During the aortic valve replacement surgery
Duration of aortic clamping
Comparison of the average duration of aortic clamping between the two groups
Measured: During the aortic valve replacement surgery
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
A composite endpoint of mortality, myocardial infarction, urgent revascularization, stroke and major bleeding
Measured: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Blood transfusion
A comparison of the number of transfusions between the groups
Measured: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Rethoracotomy for bleeding
The incidence of rethoracotomy for bleeding after surgery
Measured: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Post-operative pain
Measurement of patient's subjective assessment of their pain after surgery using a visual scale
Measured: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Duration of mechanical ventilation
Comparison of the average duration of mechanical ventilation between the groups
Measured: Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours
Length of ICU stay
Comparison of the average number of days spent in Intensive Care Unit between the two groups
Measured: From the time of surgery until the patient is discharged from hospital, an average of 30 days
Length of hospital stay
Comparison of the average number of days spent in hospital between the groups
Measured: From the time of surgery until the patient is discharged from hospital, an average of 30 days
Atrial fibrillation
Incidence of new-onset atrial fibrillation after cardiac surgery
Measured: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Wound infection
Incidence of wound infections
Measured: During the first 30 days after surgery
Mortality
intra- and postoperative mortality
Measured: During the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start16 Mar 2021
- Primary completion16 Mar 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The German Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Sophie Tkebuchava, MD, Principal investigator, University Hospital JenaTorsten Doenst, MD, Principal investigator, University Hospital Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632095
- Sponsor's protocol ID
- PASTA-UKJ
- Acronym
- PASTA
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 23 Mar 2021
- 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 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT04632095
- Acronym / sponsor ID
- PASTA / PASTA-UKJ
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic Valve Stenosis, minimally invasive surgery, parasternal approach, quality of life, aortic valve replacement, inflammatory markers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- The German Heart Foundation
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 16 Mar 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 17 Nov 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.
Prospective randomized study comparing aortic valve replacement using parasternal or sternotomy access with regard to quality of life and systemic inflammatory reaction.
Detailed description
The classic surgical treatment of aortic stenosis is valve replacement through complete midline opening of the breastbone (median sternotomy) and use of cardiopulmonary bypass (CPB). Risks of this procedure are related to both the surgical approach and the use of CPB. Using minimally invasive approaches in non-cardiac patients (e.g laparoscopy) resulted in reduced postoperative inflammatory response when compared to patients undergoing the same procedures carried out with a conventional "open" technique. Minimally invasive surgical approaches in which the sternum is partially opened (partial sternotomy) or not opened at all (parasternal access) have thus far shown similar procedure related mortality and lower incidence of perioperative complications, despite longer CPB times. Our single center experience thus far suggests superiority of parasternal aortic valve replacement (O/E ratio of 0.19 over the last 2 years), as well as a reduced postoperative inflammatory response (as measured by lower CRP (C reactive protein ) levels taken 6 hours post-surgery). However, these data have several confounders and there is currently no prospective randomized trial addressing this topic. We therefore conduct a randomized comparison of parasternal versus classic sternotomy aortic valve replacement. Based on our previous experience, we expect very low mortality risk in both groups (expected ≤ 1%). The primary endpoint is therefore quality of life assessed using the SF-36 (Short Form) health survey questionnaire. This approach is similar to other current large multicenter trials. In order to address the impact of reduced surgical trauma on inflammatory response; we will quantify an established panel of inflammatory markers (PCT, CRP, interleukin 6) and use bio-banking to allow for further in depth analysis later on. Standardized clinical endpoints will be analyzed as additional secondary parameters. Power analysis determined a number of 50 patients allocated to 2 equal groups to achieve a power of 80%. The parasternal approach is expected to be superior when compared to sternotomy in both the primary and some, if not most, secondary endpoints. We expect our study to become an important milestone for decision-making in the treatment of aortic stenosis. Patients currently fear sternotomy, but the less invasive transcatheter valve implantation appears to be limited by inferior long-term outcome. The parasternal, sternotomy-sparing, classic aortic valve replacement is therefore an attractive therapeutic alternative. Our investigation in relation to systemic inflammatory response will further shed light on the underlying mechanisms explaining differences in clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sternotomy AVR | Active comparator | Procedure: Aortic valve replacement due to sternotomyAortic valve replacement due to sternotomy |
| Mini AVR | Active comparator | Procedure: Aortic valve replacement due to parasternal right anterior mini-thoracotomyAortic valve replacement due to parasternal right anterior mini-thoracotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indication for elective isolated aortic valve replacement
- Anatomical suitability for both sternotomy and parasternal access
- Age ≥ 18
- Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Key exclusion criteria (10 listed)
- Planned simultaneous cardiac surgery interventions (Mitral valve surgery, tricuspid valve surgery, CABG, Pacemaker or defibrillator implantation, Pulmonalvenenisolation, Maze, closure of left atrial appendage , patent foramen ovale or atrial septal defect closure)
- Acute myocardial infarction within 4 weeks, coronary heart disease
- Acute endocarditis
- TIA or stroke within 6 months prior to the procedure
- Pregnant or breast-feeding women
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 |
|---|---|---|
| Aortic valve replacement due to sternotomyconventional surgery of aortic stenosis | Procedure or surgery | Sternotomy AVR |
| Aortic valve replacement due to parasternal right anterior mini-thoracotomysurgery of aortic stenosis in minimally invasive technique | Procedure or surgery | Mini AVR |
Primary outcome
Quality of life - physical function
Time frame: 30 days after surgery
Comparison of the physical quality of life between the two groups 30 days after surgery using the physical function score of the 36-Item Short Form Health Survey (SF-36). The physical function score is a scale from 0 (poor physical function) to 100 (excellent physical function, with an average score of 50. It includes items that assess physical functioning, bodily pain, physical role functioning, vitality, and generaly health perceptions.
15 secondary outcomes
Inflammatory markers: Procalcitonin, C-reactive protein, Interleukin-6
Time frame: During the first 48 hours after surgery
Quality of Life - mental function
Time frame: 30 days after surgery
Duration of the Operation
Time frame: During the aortic valve replacement surgery
Duration of cardiopulmonary bypass
Time frame: During the aortic valve replacement surgery
Duration of aortic clamping
Time frame: During the aortic valve replacement surgery
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Blood transfusion
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Rethoracotomy for bleeding
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Post-operative pain
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Duration of mechanical ventilation
Time frame: Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours
Length of ICU stay
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 30 days
Length of hospital stay
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 30 days
Atrial fibrillation
Time frame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
Wound infection
Time frame: During the first 30 days after surgery
Mortality
Time frame: During the first 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- 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.
Sophie Tkebuchava, MD principal investigator
University Hospital Jena
Torsten Doenst, MD principal investigator
University Hospital Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic valve replacement due to sternotomy and Aortic valve replacement due to parasternal right anterior mini-thoracotomy in people with Aortic Valve Stenosis, run by Jena University Hospital at 1 site in Germany.
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 4 inclusion and 10 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 23 Mar 2021. 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 Germany. 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 Sophie Tkebuchava, MD (+4936419322928, sophio.tkebuchava@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life - physical function (time frame: 30 days after surgery). 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 23 Mar 2021.