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| ID | Type | Description | Link |
|---|---|---|---|
| H-25039123 | Other Identifier | Scientific Ethics Committees for the Capital Region of Denmark |
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Optimized Expansion of the implanted transcatheter aortic valve to reduce hypoattenuating leaflet thickening in non-atrial fibrillation patients undergoing transcatheter aortic valve implantation (TAVI): an international, multicentre, randomized controlled trial.
The objective is to evaluate whether TAVI with systematic optimized pre- and post-dilatation (optimized expansion (OptEx) TAVI strategy), compared to a standard of care (SoC) TAVI strategy, is superior in reducing hypoattenuating leaflet thickening as evaluated by cardiac computed tomography (CT) imaging at three months after TAVI.
The primary outcome is at least one thickened TAV leaflet involving ≥ 25% of the leaflet curvilinear dimension as assessed at cardiac CT at three months after TAVI.
A total of 1010 patients will be included in the OptEx-TAVI trial and randomised 1:1 to either :
All patients with indication for TAVI and eligible in relation to the study in- and exclusion criteria will be offered participation in the OptEx-TAVI trial.
Inclusion criteria:
Exclusion criteria:
Baseline characteristics, medical history, procedural details, electrocardiogram, echocardiography and cardiac CT-scan parameters will be recorded by assessing medical charts and patient interview.
During the TAVI-procedure, patients will be treated according to randomisation to either SoC or OptEx
Planned post-procedural visits at:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SoC-TAVI | Active Comparator | Pre-dilatation and post-dialation optional, as per operator preference. The balloon size used for pre- or post-dilatation is left at the operator's discretion. Operators are only encouraged to post-dilate the implanted transcatheter aortic valve (TAV) in case of ≥ moderate paravalvular regurgitation or a suboptimal transvalvular gradient. |
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| OptEx-TAVI | Experimental | Systematic pre-dilatation and post-dilatation with an optimally-sized balloon |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OptEx-TAVI | Procedure | During TAVI with either self-expanding or balloon-expandable TAVs:
Optimally-sized balloon:
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| Measure | Description | Time Frame |
|---|---|---|
| At least one TAV leaflet with HALT | At least one TAV leaflet with hypoattenuated leaflet thickening (HALT) involving more than the base (≥ 25% of the leaflet curvilinear dimension) as assessed at cardiac CT-scan . | At three months after TAVI |
| Measure | Description | Time Frame |
|---|---|---|
| HALT 50% | At least one TAV leaflet with HALT involving ≥ 50% of the leaflet curvilinear dimension assessed by cardiac CT-scan | At 3 months/At 1 year |
| HALT 25% | The rate of TAV leaflets with HALT involving ≥ 25% of the leaflet curvilinear dimension assessed by cardiac CT-scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ole De Backer, MD, PhD, FESC | Contact | +4535457086 | ole.de.backer@regionh.dk | |
| Troels H Jørgensen, MD, PhD | Contact | +4535450892 | troels.hoejsgaard.joergensen.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ole De Backer, MD, PhD, FESC | The Heart Center, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZORG ziekenhuis | Recruiting | Aalst | Belgium |
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| SoC-TAVI | Procedure | During TAVI with either self-expanding or balloon-expandable TAVs: Pre-dilatation: optional, as per operator preference and post-dilatation: optional, as per operator preference. Operators are only encouraged to post-dilate the implanted TAV in case of ≥ moderate paravalvular regurgitation or a suboptimal transvalvular gradient. The balloon size used for pre- or post-dilatation is left at the operator's discretion. |
|
| At 3 months/At 1 year |
| HALT 50%, multiple | The rate of TAV leaflets with HALT involving ≥ 50% of the leaflet curvilinear dimension assessed by cardiac CT-scan | At 3 months/At 1 year |
| Bioprosthetic leaflet micro-calcification target-to-background ratio | Ratio of bioprosthetic micro-calcification activity assessed by PET CT- scan by 18F-NaF uptake originating from the valve leaflets observed on 3 orthogonal planes after co-registration of background PET activity with contrast CT angiography. Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan | At 5 years |
| Valve performance | Intended performance of the valve (mean gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation) by TTE as per VARC- 3 criteria | At 3 months/At 1 year |
| structural valve deterioration | Moderate or greater hemodynamic structural valve deterioration by TTE as per VARC-3 criteria. Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan | At 5 years |
| Bioprosthetic valve dysfunction (BVD) | Severe bioprosthetic valve dysfunction (BVD) by TTE as per VARC-3 criteria. Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan | At 5 years |
| Bioprosthetic valve failure (BVF) | As per VARC-3 criteria; Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan | At 5 years |
| Technical success | As per VARC-3 criteria | Periprocedural |
| Device success | as per VARC-3 criteria | At 3 months |
| Early safety | As per VARC-3 criteria | At 3 months |
| Clinical efficacy | As per VARC-3 criteria | At 1 year |
| Valve-related long-term clinical efficacy | As per VARC-3 criteria; Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan | At 5 years |
| Freedom from mortality | Freedom from mortality | Periprocedural, at 3 months and at 1 year |
| Risk of cardiovascular mortality | Risk of cardiovascular mortality. VARC-3 criteria | At 1 year |
| Risk of non-cardiovascular mortality | Risk of non-cardiovascular mortality. VARC-3 criteria | At 1 year |
| Risk of acute kidney injury | Risk of acute kidney injury stage 3 or 4. VARC-3 criteria | At 3 months |
| Risk of bleeding | Risk of VARC-3 type 2-4 bleeding | At 3 months, 1 year and 5 years (Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan) |
| Risk of stroke | Risk of all stroke | At 3 months and 1 year |
| Risk of thomboembolism | Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies). VARC-3 criteria. | At 5 years |
| Rate of successful access | Successful access, delivery of the device, and retrieval of the delivery system | Periprocedural |
| Freedom from surgery or intervention | Rate of freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication | Periprocedural and at 3 months |
| Risk of vascular complications | Risk of major vascular, access-related, or cardiac structural complication, VARC-3 criteria. | At 3 months |
| Risk of aortic prosthetic regurgitation | Freedom from moderate or severe aortic regurgitation. VARC-3 criteria | At 3 months |
| Risk of permanent pacemaker | Risk of new permanent pacemaker due to procedure-related conduction abnormalities | At 3 months |
| Risk of procedure or valve-related hospitalization | Risk of hospitalization for procedure- or valve-related causes. VARC-3 | At 1 year |
| CHU Charleroi | Recruiting | Charleroi | 6000 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| AZ Delta | Recruiting | Roeselare | Belgium |
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| Skejby Hospital | Not yet recruiting | Aa | 8200 | Denmark |
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| Aalborg University Hospital | Recruiting | Aalborg | 9000 | Denmark |
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| Rigshospitalet | Recruiting | Copenhagen | Denmark |
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| Odense University Hospital | Not yet recruiting | Odense C | 5000 | Denmark |
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| Turku University Hospital | Recruiting | Turku | 20520 | Finland |
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| UMC Amsterdam | Recruiting | Amsterdam | Netherlands |
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| University Medical Center Groningen | Recruiting | Groningen | Netherlands |
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| Leiden University Medical Center | Recruiting | Leiden | Netherlands |
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| St. Antonius Hospital | Recruiting | Nieuwegein | 3435 | Netherlands |
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| Haukeland hospital | Recruiting | Haukeland | Norway |
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| Oslo universitetssygehus | Recruiting | Oslo | 0450 | Norway |
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| Sahlgrenska University Hospital | Recruiting | Gothenburg | 413 45 | Sweden |
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| Skånes universitetssjukhus | Recruiting | Skåne | Sweden |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000082862 | Aortic Valve Disease |
| D014694 | Ventricular Outflow Obstruction |
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