Aortic Valve DiseaseNCT04525339
Early Outcomes of Concomitant Transcatheter Aortic Valve Implantation and Off-pump Coronary Artery Bypass Grafting in Management of Severe Symptomatic Aortic Stenosis and Coronary Artery Disease
An observational study of Aortic Valve Disease and Coronary Artery Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Study Objectives/Specific Aims Overall Goal: To study the outcomes of patients undergoing TAVI, their subsequent results and complications. Objective 1: Identify risk factors that are predictive of the need for TAVI and CABG Objective3:Assess early 3 months outcomes and postoperative results Outcome Measure: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Disease, Coronary Artery Disease
- What is being tested?
- TAVI and Off pump CABG
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients registered in cardiac surgery department, Manchester Royal Infirnary in the last five years 2015 till 2020, and who meet the listed inclusion and exclusion criteria will be eligible for the study.
Who may be able to join
- Patients with severe symptomatic aortic stenosis and CAD undergoing TAVI \& OPCABG
Who cannot join
- Patients with concomitant valvular heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Study Objectives/Specific Aims Overall Goal: To study the outcomes of patients undergoing TAVI, their subsequent results and complications.
- Objective 1: Identify risk factors that are predictive of the need for TAVI and CABG
- Objective3:Assess early 3 months outcomes and postoperative results
Outcome Measure:
- All-cause mortality within 3 months.
Secondary Outcome Measures:
- Stroke
- Myocardial infarction
- Bleeding
- Hospital stay
- Acute kidney injury
- Number of patients with conduction disturbance and pacemaker implantation
- Gradient on implanted valve
- Degree of transvalvular leakage
- 6 weeks follow-up
- 3 months Echo
Read the detailed description
Severe symptomatic aortic stenosis in elderly patients represents a surgical challenge for cardiac surgeons due to heavy calcifications and associated comorbidities. Such conditions usually are associated with dramatic intra and postoperative complications leading to many cases being declined for open surgical replacement. Many treatment modalities were described including trans-catheter valvutomy but with only temporary improvements and high rates of recurrence. Transcatheter Aortic Valve Implantation (TAVI) has offered an alternative solution to such cases in which open surgery is deemed too risky or prohibited.
Coronary artery disease (CAD) is a common comorbidity in patients undergoing TAVI. It has been reported with 40-75% of the patients with increased adverse outcomes.Despite performing TAVI alone in these patient has shown significant improvement, yet CAD has showed increased risk in terms of hemodynamic instability and risk of myocardial infarction during rapid pacing which is an important step during the TAVI procedure.
According to the AHA/ACC guidelines, in patients undergoing Aortic valve replacement/ repair (AVR) who also have significant CAD, the combination of Coronary artery bypass grafting (CABG) and AVR reduces the rates of perioperative Myocardial Infarction, perioperative mortality, late mortality, and morbidity when compared with patients not undergoing simultaneous CABG, even though the combined operation carries a small but real increased risk of mortality (Class II A).
Percutaneous coronary intervention (PCI) has been the commonly used treatment modality for (CAD) which is usually carried out pre TAVI or less commonly simultaneously with TAVI (mainly due to access limitation after valve implantation). In patients with intermediate or high SYNTAX scores, CABG remains the standard therapy. Off-pump coronary artery bypass (OPCAB) procedure has demonstrated excellent results in these patients, due to the avoidance of cardiopulmonary bypass and manipulation of the aorta.
Only a few studies in the literature have reported the combined approach of CABG and TAVI in treatment of coronary artery disease and severe symptomatic aortic stenosis. Here the invesigators decided to study the early three months outcomes of patients undergoing TAVI and surgical revascularization.
- Conditions
- Aortic Valve Disease, Coronary Artery Disease
- Being tested
- TAVI and Off pump CABG
- Medical subject headings
- Aortic Valve Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVI and Off pump CABGProcedure or surgery
Concomitant Transcatheter aortic valve implanatation and off pump coronary artery bypass grafting
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 3 months
Secondary outcomes (8)
Occurence of Stroke
Measured: I month
Occurence of Myocardial infarction
Measured: I month
Need for reexploration
Measured: I month
Occurence of Acute kidney injury
Measured: I month
Number of patients with conduction disturbance and pacemaker implantation
Measured: I month
Gradient on implanted valve
Measured: 3 months Echo
Degree of transvalvular leakage
Measured: 3 months Echo
Days of Hospital Stay
Measured: from day of operation till medically fit for discharge (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Jul 2020
- Primary completionDec 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Moustafa Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525339
- Sponsor's protocol ID
- TAVI & OPCAB
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcomes of Concomitant Transcatheter Aortic Valve Implantation and Off-pump Coronary Artery Bypass Grafting in Management of Severe Symptomatic Aortic Stenosis and Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04525339
- Acronym / sponsor ID
- TAVI & OPCAB
- Conditions
- Aortic Valve Disease, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 25 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.
Study Objectives/Specific Aims Overall Goal: To study the outcomes of patients undergoing TAVI, their subsequent results and complications.
- Objective 1: Identify risk factors that are predictive of the need for TAVI and CABG
- Objective3:Assess early 3 months outcomes and postoperative results
Outcome Measure:
- All-cause mortality within 3 months.
Secondary Outcome Measures:
- Stroke
- Myocardial infarction
- Bleeding
- Hospital stay
- Acute kidney injury
- Number of patients with conduction disturbance and pacemaker implantation
- Gradient on implanted valve
- Degree of transvalvular leakage
- 6 weeks follow-up
- 3 months Echo
Detailed description
Severe symptomatic aortic stenosis in elderly patients represents a surgical challenge for cardiac surgeons due to heavy calcifications and associated comorbidities. Such conditions usually are associated with dramatic intra and postoperative complications leading to many cases being declined for open surgical replacement. Many treatment modalities were described including trans-catheter valvutomy but with only temporary improvements and high rates of recurrence. Transcatheter Aortic Valve Implantation (TAVI) has offered an alternative solution to such cases in which open surgery is deemed too risky or prohibited.
Coronary artery disease (CAD) is a common comorbidity in patients undergoing TAVI. It has been reported with 40-75% of the patients with increased adverse outcomes.Despite performing TAVI alone in these patient has shown significant improvement, yet CAD has showed increased risk in terms of hemodynamic instability and risk of myocardial infarction during rapid pacing which is an important step during the TAVI procedure.
According to the AHA/ACC guidelines, in patients undergoing Aortic valve replacement/ repair (AVR) who also have significant CAD, the combination of Coronary artery bypass grafting (CABG) and AVR reduces the rates of perioperative Myocardial Infarction, perioperative mortality, late mortality, and morbidity when compared with patients not undergoing simultaneous CABG, even though the combined operation carries a small but real increased risk of mortality (Class II A).
Percutaneous coronary intervention (PCI) has been the commonly used treatment modality for (CAD) which is usually carried out pre TAVI or less commonly simultaneously with TAVI (mainly due to access limitation after valve implantation). In patients with intermediate or high SYNTAX scores, CABG remains the standard therapy. Off-pump coronary artery bypass (OPCAB) procedure has demonstrated excellent results in these patients, due to the avoidance of cardiopulmonary bypass and manipulation of the aorta.
Only a few studies in the literature have reported the combined approach of CABG and TAVI in treatment of coronary artery disease and severe symptomatic aortic stenosis. Here the invesigators decided to study the early three months outcomes of patients undergoing TAVI and surgical revascularization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients registered in cardiac surgery department, Manchester Royal Infirnary in the last five years 2015 till 2020, and who meet the listed inclusion and exclusion criteria will be eligible for the study.
Key inclusion criteria (1 listed)
- Patients with severe symptomatic aortic stenosis and CAD undergoing TAVI \& OPCABG
Key exclusion criteria (1 listed)
- Patients with concomitant valvular heart disease.
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 |
|---|---|---|
| TAVI and Off pump CABGConcomitant Transcatheter aortic valve implanatation and off pump coronary artery bypass grafting | Procedure or surgery | – |
Primary outcome
All-cause mortality
Time frame: 3 months
8 secondary outcomes
Occurence of Stroke
Time frame: I month
Occurence of Myocardial infarction
Time frame: I month
Need for reexploration
Time frame: I month
Occurence of Acute kidney injury
Time frame: I month
Number of patients with conduction disturbance and pacemaker implantation
Time frame: I month
Gradient on implanted valve
Time frame: 3 months Echo
Degree of transvalvular leakage
Time frame: 3 months Echo
Days of Hospital Stay
Time frame: from day of operation till medically fit for discharge (1 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
Related trials for Aortic Valve Disease
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aortic Valve Disease and Coronary Artery Disease, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 25 Aug 2020. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 3 months). 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 25 Aug 2020.