Severe Symptomatic Aortic StenosisNCT04663334
Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities
An observational study of Severe Symptomatic Aortic Stenosis, run by Nantes University Hospital at 1 site in France.
Trial summary
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis. Severe aortic stenosis is the most common indication of valvular replacement in developed countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Symptomatic Aortic Stenosis
- What is being tested?
- inverse myocardial remodeling
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2020to 8 May 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: All patients have severe symptomatic aortic stenosis, secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2) and significant epicardial coronary stenosis (> or = 50%) assessed by coronarography performed in systematic preoperative work-up. These patients are deemed for TAVI and a first-line medical treatment for CAD, after heart team decision.
Who may be able to join
- Adults older than 18 years. For female of childbearing age, active contraceptive method is recommended.
- patients with severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2) and with significant coronary artery disease (epicardial coronary stenosis angiography > or = to 50%)
Who cannot join
- Severe CAD with tritroncular lesions or severe stenosis (>90 %) of left main artery or proximal left anterior descending artery
- Lack of viability in myocardial territory of interest
- History of bypass coronary surgery or heart transplantation
- Severe left ventricular systolic dysfunction, characterized by an ejection fraction < 35 %
- Severe renal impairment (Creatinine clearance <30 ml/min/1.73 m2)
- Absolute contraindication to intravenous adenosin
- Pregnant or nursing women Patients under guardianship, curatorship, or protection of justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Change in Coronary Microcirculation and Fractional Flow Reserve After Transcatheter Aortic Valve Implantation in Patients With Concomitant Coronary Artery Disease and Severe Aortic Stenosis.
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis.
Severe aortic stenosis is the most common indication of valvular replacement in developed countries. Stable coronary artery disease (CAD) is frequently associated with severe aortic stenosis in patients treated by Transcatheter Aortic Valvular Implantation (TAVI). Its prognostic impact is not clearly established, and available studies uncommonly used functional assessment of severity from a coronary stenosis to stratify the risk in this situation.
Read more
Fractional Flow Reserve (FFR) is recommended to guide revascularization by percutaneous coronary intervention (PCI) in clinical practice. Its use is not validated in patients with severe aortic stenosis. Left ventricular hypertrophy induced by aortic obstruction leading to microvascular disorders, and can alter coronary reserve, possibly biasing FFR values. After aortic valvular replacement, a myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment.
The aim of the study is to assess the effects of inverse myocardial remodeling on coronary microcirculatory function and its association with FFR values before and after TAVI.
Read the detailed description
This monocentric and prospective observational study aims to include patients with stable coronary artery disease and undergoing TAVI for severe aortic stenosis via transfemoral access, from November 2020 at Nantes University Hospital, France.
All patients have severe symptomatic aortic stenosis, secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2) and significant epicardial coronary stenosis (> or = 50%) assessed by coronarography performed in systematic preoperative work-up. These patients are deemed for TAVI and a first-line medical treatment for CAD, after heart team decision.
The collegially chosen strategy to manage CAD in this population consists in assessing hemodynamic parameters from a coronary stenosis during the TAVI procedure, using functionals tests for ischemia (FFR, IMR, CFR) from a concomitant coronarography. Patients will be routinely admitted in hospital 6 months after TAVI, for clinical and echocardiographic reassessment, and coronarography control. Functional tests will be repeated and according to results, continuation of medical therapy or PCI is proposed, at operator's discretion.
All procedures are performed within the same site by 1 medical team including 4 interventional cardiologists.
Before the TAVI procedure, a computerized multi-sliced tomography is systematically performed to validate the percutaneous approach by femoral access and to choose which prothesis model will be used.
In most cases, TAVI procedure are performed under local anesthesia and mild sedation, under anesthetist supervision.
The common femoral artery is punctured by percutaneous approach, above the femoral bifurcation and a 16-French sheath is inserted.
Three available models of aortic bioprothesis are implanted in our center, the Sapien 3 (EDWARDS Lifescience) the Corevalve Evolute R (Metdtronik) and the Accurate Neo 2 (Boston Scientific) Two Perclose ProGlide devices (Abbott Vascular) are used to perform the perpendicular preclosing. After the deployment of the prosthesis, the TAVI sheath is removed and the nodes from the two previously placed ProGlide devices are tightened. Final femoral angiographic control is not systematic.
Concomitant coronarography is performed by radial artery access site, using a 6-French sheath.
Hemodynamics measures are recorded by PressureWire X Guidewire (Abott Vascular) wireless devices to a computer and processed by the CoroFlow Coroventis software (Abbott Vascular) to carry out multimodal physiological evaluation. FFR, CFR, and IMR measures will be repeated before and immediately after valve implantation. These parameters will be reassessed 6 months after TAVI.
- Conditions
- Severe Symptomatic Aortic Stenosis
- Being tested
- inverse myocardial remodeling
- Keywords
- Coronary Flow Reserve, Index of Microvascular Resistance, Fractional Flow Reserve, Transcatheter Aortic Valve Implantation, Coronary Artery Disease, Severe Aortic Stenosis
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inverse myocardial remodelingOther
a myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the change in FFR values before and 6 months after TAVI
FFR values are presented as median and interquartile range. FFR values comparisons pre-TAVI, post-TAVI, and 6 month after procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start8 Dec 2020
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Symptomatic Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Manigold, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663334
- Sponsor's protocol ID
- AP001
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2020
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Battistolo Q, Le Ruz R, Piriou PG, Guerin P, Letocart V, Plessis J, Poinas A, Senage T, Manigold T. Changes in microcirculation following transcatheter aortic valve implantation in patients with stable coronary artery disease. Arch Cardiovasc Dis. 2025 Apr;118(4):222-230. doi: 10.1016/j.acvd.2024.12.006. Epub 2024 Dec 21.
PubMed 39827054
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Coronary Microcirculation and Fractional Flow Reserve After Transcatheter Aortic Valve Implantation in Patients With Concomitant Coronary Artery Disease and Severe Aortic Stenosis.
- ClinicalTrials.gov ID
- NCT04663334
- Acronym / sponsor ID
- AP001
- Conditions
- Severe Symptomatic Aortic Stenosis
- Keywords
- Coronary Flow Reserve, Index of Microvascular Resistance, Fractional Flow Reserve, Transcatheter Aortic Valve Implantation, Coronary Artery Disease, Severe Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 11 Dec 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.
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis.
Severe aortic stenosis is the most common indication of valvular replacement in developed countries. Stable coronary artery disease (CAD) is frequently associated with severe aortic stenosis in patients treated by Transcatheter Aortic Valvular Implantation (TAVI). Its prognostic impact is not clearly established, and available studies uncommonly used functional assessment of severity from a coronary stenosis to stratify the risk in this situation.
Fractional Flow Reserve (FFR) is recommended to guide revascularization by percutaneous coronary intervention (PCI) in clinical practice. Its use is not validated in patients with severe aortic stenosis. Left ventricular hypertrophy induced by aortic obstruction leading to microvascular disorders, and can alter coronary reserve, possibly biasing FFR values. After aortic valvular replacement, a myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment.
The aim of the study is to assess the effects of inverse myocardial remodeling on coronary microcirculatory function and its association with FFR values before and after TAVI.
Detailed description
This monocentric and prospective observational study aims to include patients with stable coronary artery disease and undergoing TAVI for severe aortic stenosis via transfemoral access, from November 2020 at Nantes University Hospital, France.
All patients have severe symptomatic aortic stenosis, secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2) and significant epicardial coronary stenosis (> or = 50%) assessed by coronarography performed in systematic preoperative work-up. These patients are deemed for TAVI and a first-line medical treatment for CAD, after heart team decision.
The collegially chosen strategy to manage CAD in this population consists in assessing hemodynamic parameters from a coronary stenosis during the TAVI procedure, using functionals tests for ischemia (FFR, IMR, CFR) from a concomitant coronarography. Patients will be routinely admitted in hospital 6 months after TAVI, for clinical and echocardiographic reassessment, and coronarography control. Functional tests will be repeated and according to results, continuation of medical therapy or PCI is proposed, at operator's discretion.
All procedures are performed within the same site by 1 medical team including 4 interventional cardiologists.
Before the TAVI procedure, a computerized multi-sliced tomography is systematically performed to validate the percutaneous approach by femoral access and to choose which prothesis model will be used.
In most cases, TAVI procedure are performed under local anesthesia and mild sedation, under anesthetist supervision.
The common femoral artery is punctured by percutaneous approach, above the femoral bifurcation and a 16-French sheath is inserted.
Three available models of aortic bioprothesis are implanted in our center, the Sapien 3 (EDWARDS Lifescience) the Corevalve Evolute R (Metdtronik) and the Accurate Neo 2 (Boston Scientific) Two Perclose ProGlide devices (Abbott Vascular) are used to perform the perpendicular preclosing. After the deployment of the prosthesis, the TAVI sheath is removed and the nodes from the two previously placed ProGlide devices are tightened. Final femoral angiographic control is not systematic.
Concomitant coronarography is performed by radial artery access site, using a 6-French sheath.
Hemodynamics measures are recorded by PressureWire X Guidewire (Abott Vascular) wireless devices to a computer and processed by the CoroFlow Coroventis software (Abbott Vascular) to carry out multimodal physiological evaluation. FFR, CFR, and IMR measures will be repeated before and immediately after valve implantation. These parameters will be reassessed 6 months after TAVI.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients have severe symptomatic aortic stenosis, secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2) and significant epicardial coronary stenosis (> or = 50%) assessed by coronarography performed in systematic preoperative work-up. These patients are deemed for TAVI and a first-line medical treatment for CAD, after heart team decision.
Key inclusion criteria (2 listed)
- Adults older than 18 years. For female of childbearing age, active contraceptive method is recommended.
- patients with severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2) and with significant coronary artery disease (epicardial coronary stenosis angiography > or = to 50%)
Key exclusion criteria (7 listed)
- Severe CAD with tritroncular lesions or severe stenosis (>90 %) of left main artery or proximal left anterior descending artery
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 |
|---|---|---|
| inverse myocardial remodelinga myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment | Other | – |
Primary outcome
Study the change in FFR values before and 6 months after TAVI
Time frame: 6 months
FFR values are presented as median and interquartile range. FFR values comparisons pre-TAVI, post-TAVI, and 6 month after procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 39827054Battistolo Q, Le Ruz R, Piriou PG, Guerin P, Letocart V, Plessis J, Poinas A, Senage T, Manigold T. Changes in microcirculation following transcatheter aortic valve implantation in patients with stable coronary artery disease. Arch Cardiovasc Dis. 2025 Apr;118(4):222-230. doi: 10.1016/j.acvd.2024.12.006. Epub 2024 Dec 21.
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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.
Thierry Manigold study director
Nantes University Hospital
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 Severe Symptomatic Aortic Stenosis, run by Nantes University Hospital at 1 site in France.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 15 Dec 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study the change in FFR values before and 6 months after TAVI (time frame: 6 months). 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 NCT04663334, which also lists 1 linked publication.
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 15 Dec 2023.