Transcatheter Aortic Valve ReplacementNCT04517955
TAVI in Intermediate Risk Septuagenarians With Risk Factors Not Captured by the Traditional Surgical Risk Scores
An observational study of Transcatheter Aortic Valve Replacement, run by University of Athens at 5 sites in Greece.
Trial summary
Single arm, observational trial of Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic Evolut R and Evolut Pro The primary objective of this trial is to evaluate device success of TAVI with the Evolut R and Evolut Pro systems in septuagenarians with risk factors for adverse surgical outcomes not captured… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- What is being tested?
- Transcatheter Aortic Valve Implantation (TAVI)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 5 sitesGreece
- Study dates
- 1 Jul 2020to 30 Mar 2025
- How long will I take part?
- 2 Years
- 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 75-79 years old who have symptomatic severe aortic stenosis at intermediate surgical risk defined by a Society of Thoracic Surgeons (STS) mortality risk of >=4% and <=8%, will be presented to the Heart Team for inclusion in the trial. Patients will have risk factors not captured by traditional risk scores
Who may be able to join
- Age 75-79
- Subject must have Society of Thoracic Surgeons (STS) score >=4% and <=8%
- Subject must have at least one from the risk factors presented below:
- Severely atherosclerotic or porcelain aorta ii. Internal Mammary Artery (IMA) or other conduit(s) crossing midline and/or adherent to posterior table of sternum iii. Pre-existing mechanical valve in any other position iv. Severe right ventricular dysfunction v. Hostile chest (abnormal chest wall anatomy due to severe kyphoscoliosis or other skeletal abnormalities, evidence of severe radiation damage, history of multiple recurrent pleural effusions causing internal adhesions) vi. Severe liver disease/cirrhosis vii. Frailty viii. Malignancy with life expectancy that exceeds 24 months ix. Renal replacement therapy with creatinine levels >200mmol/L or 2.26 mg/dl
- Heart team consisting of at least one interventional cardiologist and one cardiac surgeon agree on indication and treatment proposal, based on their clinical judgment (including anatomy assessment, risk factors, etc)
- Critical aortic valve area defined as an initial aortic valve area of <=1cm2 or aortic valve index <0.6cm2/m2
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- In presence of normal left ventricular function:
- Mean gradient >40mmHg OR Vmax>4m/sec OR
- In presence of low flow, low gradient severe AS, a dobutamine stress echo must be conducted that demonstrates presence of contractile reserve defined as follows >=20% increase in stroke volume and mean gradient >40mmHg
- Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater
- The subject is suitable for direct TAVI not preceded by balloon valvuloplasty according to the judgment of the treating physicians
- The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits.
Who cannot join
- Hypersensitivity or contraindication to aspirin, heparin, clopidogrel, coumadin, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
- Blood dyscrasias as defined: leukopenia (WBC<1000/mm3), thrombocytopenia (platelet count <50.000cells/mm3), history of bleeding diathesis or coagulopathy;
- Ongoing sepsis, including active endocarditis
- Any condition considered a contraindication to extracorporeal assistance;
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks prior treatment
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence or mechanical hemodynamic support;
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- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Active gastrointestinal (GI) bleeding within the past 3 months
- Subject refuses a blood transfusion;
- Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
- Multivessel coronary artery disease with a Syntax score >22
- Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions
- Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consentor adherence to the protocol required follow-up exams;
- Currently participating in an investigational drug or another device trial (excluding registries)
- Evidence of an acute myocardial infarction <=30 days before the index procedure
- Need for emergency surgery for any reason
- Uncontrolled atrial fibrillation
- Anatomical Exclusion Criteria:
- Native aortic annulus size <18mm or >30mm per the baseline diagnostic imaging;
- Mixed aortic valve disease [aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+]
- Severe mitral or severe tricuspid regurgitation
- Severe mitral stenosis;
- Hypertrophic obstructive cardiomyopathy
- Echocardiographic or Multislice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus or vegetation
- Anatomy of the aortic root and ascending aorta not suitable for TAVI with Evolut R or Evolut Pro system (aortic root angulation >70 degrees for femoral and left subclavian access or >30 degrees for right subclavian access)
- Congenital bicuspid or unicuspid valve verified by echocardiography Vascular Exclusion Criteria
- Transarterial access not able to accommodate an 16 French sheath
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Greece5 sites, 5 recruiting
- Not yet recruiting
Cardiology Department, Hippokration Hospital
Athens, 11527
Dimitris Syrseloudis, MD
- Recruiting
First Department of Cardiology, National & Kapodistrian University of Athens
Athens, 11527
Konstantinos Toutouzas, Prof, +302132088099, ktoutouz@med.uoa.gr
- Not yet recruiting
Onassis Cardiac Surgery Center
Athens, 17674
Vassilios Voudris, MD
- Not yet recruiting
University Hospital of Heraklion
Heraklion, 71110
Fragkiskos Parthenakis, Prof
- Not yet recruiting
University Hospital of Ioannina
Ioannina, 45500
Lampros Michalis, Prof
About this study
Single arm, observational trial of Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic Evolut R and Evolut Pro The primary objective of this trial is to evaluate device success of TAVI with the Evolut R and Evolut Pro systems in septuagenarians with risk factors for adverse surgical outcomes not captured by the traditional risk scores and therefore of intermediate surgical risk.
Read the detailed description
The purpose of this study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in septuagenarians with severe, symptomatic Aortic Stenosis (AS) and risk factors for adverse surgical outcomes not captured by the traditional risk scores and therefore of intermediate surgical risk.
The primary objective of this trial is to evaluate device success of TAVI with the Evolut R and Evolut Pro systems in septuagenarians with risk factors for adverse surgical outcomes not captured by the traditional risk scores and therefore of intermediate surgical risk.
The secondary objective is to assess early safety (at 30 days) and clinical efficacy (after 30 days) of the TAVI procedure.
Exploratory objective: comparative health economics in septuagenarians with symptomatic severe aortic stenosis and intermediate surgical risk treated with Transcatheter Aortic Valve Implantation (TAVI) vs Surgical Aortic Valve Replacement (SAVR) (matched historic cohort)
- Conditions
- Transcatheter Aortic Valve Replacement
- Being tested
- Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- aortic stenosis, TAVI, Evolut R, Evolut Pro
- 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 Valve Implantation (TAVI)Device
Also called Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter Aortic Valve Implantation with Evolut R or Evolut Pro
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success (VARC-2 criteria)
- Absence of procedural mortality
- Correct positioning of the prosthetic heart valve into the proper anatomical location
- Intended performance of the prosthetic heart valve (mean aortic valve gradient<20mmHg or peak velocity < 3m/s, and no moderate or severe prosthetic valve regurgitation) as assessed with 24h post implantation and pre-discharge echocardiogram
Measured: 30 days
Secondary outcomes (12)
Rate of All-cause mortality
Early Safety
Measured: 30 days
Rate of All stroke (disabling and non-disabling)
Early Safety
Measured: 30 days
Rate of Life-threatening bleeding
Early Safety
Measured: 30 days
Rate of Acute Kidney Injury-Stage 2 or 3 (including renal replacement therapy)
Early Safety
Measured: 30 days
Rate of Coronary artery obstruction requiring intervention
Early Safety
Measured: 30 days
Rate of Major vascular complication
Early Safety
Measured: 30 days
Rate of Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)
Early Safety
Measured: 30 days
Rate of New pacemaker implantation
Early Safety
Measured: 30 days
Rate of All-cause mortality
Clinical Efficacy
Measured: after 30 days and up to 2 years
Rate of All stroke (disabling and non-disabling)
Clinical Efficacy
Measured: after 30 days and up to 2 years
Rate of Hospitalizations for valve-related symptoms or worsening congestive heart failure NYHA class III or IV
Clinical Efficacy
Measured: after 30 days and up to 2 years
Rate of Valve related dysfunction
Mean aortic valve gradient >=20mmHg, Effective orifice area (EOA)<=0.9-1.1cm2, and/or Dimensionless Valve Index (DVI)<0.35 m/s and/or moderate or severe prosthetic valve regurgitation
Measured: after 30 days and up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Jul 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies 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
- 80 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitris Tousoulis, University of Athens
- Investigators
- Dimitris Tousoulis, Prof, Principal investigator, First Department of Cardiology, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517955
- Sponsor's protocol ID
- 088891/2019
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAVI in Intermediate Risk Septuagenarians With Risk Factors Not Captured by the Traditional Surgical Risk Scores
- ClinicalTrials.gov ID
- NCT04517955
- Acronym / sponsor ID
- 088891/2019
- Conditions
- Transcatheter Aortic Valve Replacement
- Keywords
- aortic stenosis, TAVI, Evolut R, Evolut Pro
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 19 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.
Single arm, observational trial of Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic Evolut R and Evolut Pro The primary objective of this trial is to evaluate device success of TAVI with the Evolut R and Evolut Pro systems in septuagenarians with risk factors for adverse surgical outcomes not captured by the traditional risk scores and therefore of intermediate surgical risk.
Detailed description
The purpose of this study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in septuagenarians with severe, symptomatic Aortic Stenosis (AS) and risk factors for adverse surgical outcomes not captured by the traditional risk scores and therefore of intermediate surgical risk.
The primary objective of this trial is to evaluate device success of TAVI with the Evolut R and Evolut Pro systems in septuagenarians with risk factors for adverse surgical outcomes not captured by the traditional risk scores and therefore of intermediate surgical risk.
The secondary objective is to assess early safety (at 30 days) and clinical efficacy (after 30 days) of the TAVI procedure.
Exploratory objective: comparative health economics in septuagenarians with symptomatic severe aortic stenosis and intermediate surgical risk treated with Transcatheter Aortic Valve Implantation (TAVI) vs Surgical Aortic Valve Replacement (SAVR) (matched historic cohort)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 75-79 years old who have symptomatic severe aortic stenosis at intermediate surgical risk defined by a Society of Thoracic Surgeons (STS) mortality risk of >=4% and <=8%, will be presented to the Heart Team for inclusion in the trial. Patients will have risk factors not captured by traditional risk scores
Key inclusion criteria (12 listed)
- Age 75-79
- Subject must have Society of Thoracic Surgeons (STS) score >=4% and <=8%
- Subject must have at least one from the risk factors presented below:
- Heart team consisting of at least one interventional cardiologist and one cardiac surgeon agree on indication and treatment proposal, based on their clinical judgment (including anatomy assessment, risk factors, etc)
- Critical aortic valve area defined as an initial aortic valve area of <=1cm2 or aortic valve index <0.6cm2/m2
Key exclusion criteria (27 listed)
- Hypersensitivity or contraindication to aspirin, heparin, clopidogrel, coumadin, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
- Blood dyscrasias as defined: leukopenia (WBC<1000/mm3), thrombocytopenia (platelet count <50.000cells/mm3), history of bleeding diathesis or coagulopathy;
- Ongoing sepsis, including active endocarditis
- Any condition considered a contraindication to extracorporeal assistance;
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks prior treatment
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 Valve Implantation (TAVI)Also: Transcatheter Aortic Valve Replacement (TAVR)Transcatheter Aortic Valve Implantation with Evolut R or Evolut Pro | Device | – |
Primary outcome
Device success (VARC-2 criteria)
Time frame: 30 days
1. Absence of procedural mortality 2. Correct positioning of the prosthetic heart valve into the proper anatomical location 3. Intended performance of the prosthetic heart valve (mean aortic valve gradient<20mmHg or peak velocity < 3m/s, and no moderate or severe prosthetic valve regurgitation) as assessed with 24h post implantation and pre-discharge echocardiogram
12 secondary outcomes
Rate of All-cause mortality
Time frame: 30 days
Rate of All stroke (disabling and non-disabling)
Time frame: 30 days
Rate of Life-threatening bleeding
Time frame: 30 days
Rate of Acute Kidney Injury-Stage 2 or 3 (including renal replacement therapy)
Time frame: 30 days
Rate of Coronary artery obstruction requiring intervention
Time frame: 30 days
Rate of Major vascular complication
Time frame: 30 days
Rate of Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)
Time frame: 30 days
Rate of New pacemaker implantation
Time frame: 30 days
Rate of All-cause mortality
Time frame: after 30 days and up to 2 years
Rate of All stroke (disabling and non-disabling)
Time frame: after 30 days and up to 2 years
Rate of Hospitalizations for valve-related symptoms or worsening congestive heart failure NYHA class III or IV
Time frame: after 30 days and up to 2 years
Rate of Valve related dysfunction
Time frame: after 30 days and up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Transcatheter Aortic Valve Replacement
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
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.
Dimitris Tousoulis, Prof principal investigator
First Department of Cardiology, University of Athens
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Replacement, run by University of Athens at 5 sites in Greece.
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 12 inclusion and 27 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 19 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 5 sites in Greece. 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 Dimitris Tousoulis, Prof (+302132088099, tousoulis@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device success (VARC-2 criteria) (time frame: 30 days). 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 19 Aug 2020.