Aortic Valve StenosisTAVINCT03633383
Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis
An observational study of Aortic Valve Stenosis, run by Assiut University.
Trial summary
TAVI is still a relatively new technique that is emerging with advance in the percutaneous and implantable valve technology. Despite its safe use in inoperable and high risk patients with severe symptomatic aortic valve stenosis, minimizing complications, predictors of outcomes and approach preference is still an area… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Transcatheter aortic valve
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2018to Jan 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 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 undergoing TAVI.
Who cannot join
- Patients with concomitant valvular heart disease.
Trial locations and contacts
No sites are listed yet.
About this study
TAVI is still a relatively new technique that is emerging with advance in the percutaneous and implantable valve technology. Despite its safe use in inoperable and high risk patients with severe symptomatic aortic valve stenosis, minimizing complications, predictors of outcomes and approach preference is still an area of study. Here we decided to study the outcomes of patients undergoing TAVI, different approaches used and their subsequent results and complications.
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 valvotomy 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. Percutaneous Heart Valves (PHV) implantations have been experimented on animals since the early 1990s. Yet the first human case was not reported till 2002, in which a percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed and implanted through the antegrade trans-septal approach in a patient presenting with severe calcific aortic stenosis associated with many noncardiac comorbidities including leg ischaemia. Despite Patient's death after 17 weeks due to noncardiac causes, his follow-up showed significant improvement of left ventricle (LV) function and aortic valve area after implantation of the percutaneous valve.
This case was followed by several single-center and small multicenter registries and series that included inoperable or very-high-risk patients, which were associated with promising results that confirmed the feasibility of TAVI.
Many approaches are used for TAVI with the transfemoral approach being the primary option. Abnormalities of the iliofemoral anatomy have led to the emergence of other approaches including transapical, subclavian, axillary, and transaortic routes. Potential advantages of such approaches would be the avoidance of using large catheters though the iliofemoral system, aortic arch, ascending aorta, and aortic valve. Yet, their main disadvantage would be the need for general anaesthesia.
As any surgical procedure, TAVI carries some risk of complications, major vascular injuries, stroke, conduction abnormalities, myocardial infarction, coronary obstruction and acute kidney injury have been reported. Although, careful planning, patient selection, perioperative workup and individualised approach choice play an important role in avoiding such problems.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transcatheter aortic valve
- 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.
Transcatheter aortic valveDevice
Self-expandable aortic valve prothesis
| Study group | Role | What they receive |
|---|---|---|
| Transfemoral Approach | Not described Receives: Device: Transcatheter aortic valve | |
| Transapical Approach | Not described Receives: Device: Transcatheter aortic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Causes of mortality such stroke, myocardial infarction, kidney injury,bleeding
Measured: one month
Secondary outcomes (8)
Stroke
Major or minor
Measured: One month
Myocardial infarction
Measured: One month after tavi
Bleeding
Amount of blood loss post Tavi
Measured: One month after tavi
Hospital stay
Calculated in days
Measured: One month
Acute kidney injury
According to RIFLE system
Measured: One month
Number of patients with conduction disturbance and pacemaker implantation
AV block by Electrocardiogram
Measured: 6 months
Gradient on implanted valve
By echocardiography measured in mmhg
Measured: One month
Degree of transvalvular leakage
By echocardiography divided in no, mild, moderate and severe
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start31 Aug 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa Mohamed, Assiut University
- Investigators
- Ahmed Ghoneim, Professor, Study chair, Assiut UniversityHussien Elkhayat, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633383
- Sponsor's protocol ID
- 17200225
- Other IDs
- 1906
- Acronym
- TAVI
- Status last verified
- Aug 2018
- First submitted
- 14 Jul 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur Heart J. 1992 May;13(5):704-8. doi: 10.1093/oxfordjournals.eurheartj.a060238.
PubMed 1618213Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.
PubMed 12473543Rodes-Cabau J. Transcatheter aortic valve implantation: current and future approaches. Nat Rev Cardiol. 2011 Nov 15;9(1):15-29. doi: 10.1038/nrcardio.2011.164.
PubMed 22083020Chow SC, Cheung GS, Lee AP, Wu EB, Ho JY, Kwok MW, Yu PS, Wan IY, Underwood MJ, Wong RH. Transcatheter aortic valve implantation: the transaortic approach. Asian Cardiovasc Thorac Ann. 2017 Jun;25(5):357-363. doi: 10.1177/0218492317702027. Epub 2017 May 17.
PubMed 28513189Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, Antoniucci D, Napodano M, De Carlo M, Fiorina C, Ussia GP. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011 Jan 25;123(3):299-308. doi: 10.1161/CIRCULATIONAHA.110.946533. Epub 2011 Jan 10.
PubMed 21220731Masson JB, Kovac J, Schuler G, Ye J, Cheung A, Kapadia S, Tuzcu ME, Kodali S, Leon MB, Webb JG. Transcatheter aortic valve implantation: review of the nature, management, and avoidance of procedural complications. JACC Cardiovasc Interv. 2009 Sep;2(9):811-20. doi: 10.1016/j.jcin.2009.07.005.
PubMed 19778768
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03633383
- Acronym / sponsor ID
- TAVI / 17200225
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Aug 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 16 Aug 2018 (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.
TAVI is still a relatively new technique that is emerging with advance in the percutaneous and implantable valve technology. Despite its safe use in inoperable and high risk patients with severe symptomatic aortic valve stenosis, minimizing complications, predictors of outcomes and approach preference is still an area of study. Here we decided to study the outcomes of patients undergoing TAVI, different approaches used and their subsequent results and complications.
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 valvotomy 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. Percutaneous Heart Valves (PHV) implantations have been experimented on animals since the early 1990s. Yet the first human case was not reported till 2002, in which a percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed and implanted through the antegrade trans-septal approach in a patient presenting with severe calcific aortic stenosis associated with many noncardiac comorbidities including leg ischaemia. Despite Patient's death after 17 weeks due to noncardiac causes, his follow-up showed significant improvement of left ventricle (LV) function and aortic valve area after implantation of the percutaneous valve.
This case was followed by several single-center and small multicenter registries and series that included inoperable or very-high-risk patients, which were associated with promising results that confirmed the feasibility of TAVI.
Many approaches are used for TAVI with the transfemoral approach being the primary option. Abnormalities of the iliofemoral anatomy have led to the emergence of other approaches including transapical, subclavian, axillary, and transaortic routes. Potential advantages of such approaches would be the avoidance of using large catheters though the iliofemoral system, aortic arch, ascending aorta, and aortic valve. Yet, their main disadvantage would be the need for general anaesthesia.
As any surgical procedure, TAVI carries some risk of complications, major vascular injuries, stroke, conduction abnormalities, myocardial infarction, coronary obstruction and acute kidney injury have been reported. Although, careful planning, patient selection, perioperative workup and individualised approach choice play an important role in avoiding such problems.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfemoral Approach | – | Device: Transcatheter aortic valve |
| Transapical Approach | – | Device: Transcatheter aortic valve |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients 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 undergoing TAVI.
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 |
|---|---|---|
| Transcatheter aortic valveSelf-expandable aortic valve prothesis | Device | Transapical Approach, Transfemoral Approach |
Primary outcome
All cause mortality
Time frame: one month
Causes of mortality such stroke, myocardial infarction, kidney injury,bleeding
8 secondary outcomes
Stroke
Time frame: One month
Myocardial infarction
Time frame: One month after tavi
Bleeding
Time frame: One month after tavi
Hospital stay
Time frame: One month
Acute kidney injury
Time frame: One month
Number of patients with conduction disturbance and pacemaker implantation
Time frame: 6 months
Gradient on implanted valve
Time frame: One month
Degree of transvalvular leakage
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Background: PubMed 1618213Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur Heart J. 1992 May;13(5):704-8. doi: 10.1093/oxfordjournals.eurheartj.a060238.
- Background: PubMed 12473543Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.
- Background: PubMed 22083020Rodes-Cabau J. Transcatheter aortic valve implantation: current and future approaches. Nat Rev Cardiol. 2011 Nov 15;9(1):15-29. doi: 10.1038/nrcardio.2011.164.
- Background: PubMed 28513189Chow SC, Cheung GS, Lee AP, Wu EB, Ho JY, Kwok MW, Yu PS, Wan IY, Underwood MJ, Wong RH. Transcatheter aortic valve implantation: the transaortic approach. Asian Cardiovasc Thorac Ann. 2017 Jun;25(5):357-363. doi: 10.1177/0218492317702027. Epub 2017 May 17.
- Background: PubMed 21220731Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, Antoniucci D, Napodano M, De Carlo M, Fiorina C, Ussia GP. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011 Jan 25;123(3):299-308. doi: 10.1161/CIRCULATIONAHA.110.946533. Epub 2011 Jan 10.
- Background: PubMed 19778768Masson JB, Kovac J, Schuler G, Ye J, Cheung A, Kapadia S, Tuzcu ME, Kodali S, Leon MB, Webb JG. Transcatheter aortic valve implantation: review of the nature, management, and avoidance of procedural complications. JACC Cardiovasc Interv. 2009 Sep;2(9):811-20. doi: 10.1016/j.jcin.2009.07.005.
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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.
Ahmed Ghoneim, Professor study chair
Assiut University
Hussien Elkhayat, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Assiut University.
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 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Moustafa Mohamed (01002826100 ext. 002, moustafaelbadry.90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03633383, which also lists 6 linked publications.
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 16 Aug 2018.