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| Name | Class |
|---|---|
| Volcano Corporation | INDUSTRY |
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Coronary artery blockages can reduce blood flow to the heart muscle. Fractional flow reserve (iFR or FFR) assessment is an invasive tool used to determine how much blood flow is reduced. The investigators will perform iFR/FFR on all intermediate coronary stenoses using standard practice, immediately before (at the time of) transcatheter aortic valve replacement (TAVR) and after successful TAVR. The investigators will compare pre- and post-TAVR iFR/FFR values, and assess short-term outcomes. The investigators hypothesize that iFR/FFR values will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same lesions.
The purpose of the study is to determine whether iFR assessment gives a valid assessment of coronary hemodynamics in patients with severe aortic stenosis.
Several factors confound the interpretation of fractional flow reserve (FFR) in patients with severe aortic stenosis (AS) and intermediate severity coronary stenoses, and the widely accepted cut-off value of 0.80 may not be applicable to this patient population. Coronary flow reserve is known to be attenuated under conditions of left ventricular hypertrophy and severe AS, with one study showing improvement in coronary flow reserve after aortic valve replacement. Left ventricular hypertrophy produces fixed resistance secondary to external compression of the coronary microcirculation. This potentially results in failure to achieve maximal hyperemia with adenosine and can lead to false negative FFR results. Neurohormonal influences in aortic stenosis can further attenuate vasodilator response and potentially result in false negative FFR values. Both of these conditions result in the potential deferral of lesions which may have been hemodynamically significant in the absence of severe AS. At present, there are no studies which have demonstrated validity of FFR measurement in patients with severe AS. Here, the investigators propose a prospective study of iFR/FFR in patients with AS and indeterminate coronary lesions undergoing TAVR to understand the hemodynamic consequences of AS on iFR/FFR. The investigators hypothesize that iFR/FFR values will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFR/iFR arm | Experimental | Volcano iFR/FFR Verrata Plus coronary pressure/flow wire |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volcano iFR/FFR Verrata Plus coronary pressure/flow wire | Device | We will measure the degree of flow-limitation of intermediate severity coronary steonses using the iFR/FFR Verrata Plus coronary pressure/flow wire before and after transcatheter aortic valve replacement. |
| Measure | Description | Time Frame |
|---|---|---|
| FFR Values Prior to Transcatheter Aortic Valve Replacement | Hemodynamic significance of a coronary stenosis by measuring FFR immediately prior to TAVR | Immediately prior to transcatheter aortic valve replacement, during the index procedure |
| FFR Values During the Transcatheter Aortic Valve Replacement (TAVR) | Hemodynamic significance of a coronary stenosis by measuring FFR immediately after TAVR | Immediately after transcatheter aortic valve replacement, during the index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir R Kapadia, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FFR/iFR Arm | Volcano iFR/FFR Verrata Plus coronary pressure/flow wire Volcano iFR/FFR Verrata Plus coronary pressure/flow wire: We will measure the degree of flow-limitation of intermediate severity coronary steonses using the iFR/FFR Verrata Plus coronary pressure/flow wire before and after transcatheter aortic valve replacement. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2017 | Nov 15, 2022 |
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A single group of patients with severe aortic stenosis and intermediate coronary stenoses will undergo coronary physiology assessment with iFR/FFR before and after transcatheter aortic valve replacement.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FFR/iFR Arm | Volcano iFR/FFR Verrata Plus coronary pressure/flow wire Volcano iFR/FFR Verrata Plus coronary pressure/flow wire: We will measure the degree of flow-limitation of intermediate severity coronary steonses using the iFR/FFR Verrata Plus coronary pressure/flow wire before and after transcatheter aortic valve replacement. |
| Units | Counts |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FFR Values Prior to Transcatheter Aortic Valve Replacement | Hemodynamic significance of a coronary stenosis by measuring FFR immediately prior to TAVR | 1 patient did not have the FFR value documented | Posted | Mean | Standard Error | ratio | Immediately prior to transcatheter aortic valve replacement, during the index procedure |
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| Primary | FFR Values During the Transcatheter Aortic Valve Replacement (TAVR) | Hemodynamic significance of a coronary stenosis by measuring FFR immediately after TAVR | 1 patient did not have the FFR value documented | Posted | Mean | Standard Error | ratio | Immediately after transcatheter aortic valve replacement, during the index procedure |
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During the index procedure, an average of 1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interventional Arm | Measure FFR with Volcano Verrata Plus coronary pressure/flow wire during the TAVR procedure. By using the Volcano Verrata Plus coronary pressure/flow wire, measure the degree of flow-limitation of intermediate severity coronary steonses using the Verrata Plus coronary pressure/flow wire before and after transcatheter aortic valve replacement. | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samir Kapadia, MD | Cleveland Clinic | 216-444-6735 | kapadis@ccf.org |
| Prot_001.pdf |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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