Coronary Artery Disease Clinical Trial
— POTUSOfficial title:
Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions in Patients With Severe Aortic Stenosis or Mitral Regurgitation
NCT number | NCT05374733 |
Other study ID # | POTUS |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 22, 2021 |
Est. completion date | March 1, 2023 |
Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | March 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18. - a) TAVI cohort: severe aortic valve stenosis for which TAVI is scheduled after discussion in the Heart Team. b) TMVr cohort: severe functional/degenerative mitral regurgitation for which TMVr is scheduled after discussion in the Heart Team. - At least intermediate coronary artery disease, defined as 50-99% diameter stenosis in a vessel = 2.5 mm - Elective procedure - Written informed consent Exclusion Criteria: - TAVI cohort: height coronary ostia < 10 mm - Severe chronic kidney disease, defined as estimated glomerular filtration rate < 30 ml/min. - Contra-indication for intravenous adenosine: severe asthma or chronic obstructive pulmonary disease, known allergy to adenosine or previous reported bronchospasm in response to adenosine. - Degenerated surgical or transcatheter aortic valve bioprosthesis. - Vessels that have collaterals to a chronic total occlusion or that are supplied by an arterial or venous bypass graft will not be interrogated in this study. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus MC | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The difference in the mean change in the FFR between the TAVI cohort and the TMVR cohort. | The mean change in the FFR in TAVI patients will be compared to mean change in FFR in TMVr patients. | Baseline | |
Other | The difference in the mean change in the RFR between the TAVI cohort and the TMVR cohort. | The mean change in the RFR in TAVI patients will be compared to mean change in RFR in TMVr patients. | Baseline | |
Other | The difference in the mean change in the dPR between the TAVI cohort and the TMVR cohort. | The mean change in the dPR in TAVI patients will be compared to mean change in dPR in TMVr patients. | Baseline | |
Other | The difference in the mean change in the Pd/Pa between the TAVI cohort and the TMVR cohort. | The mean change in the Pd/Pa in TAVI patients will be compared to mean change in Pd/Pa in TMVr patients. | Baseline | |
Other | The number of patients in who the post FFR, RFR, Pd/Pa or dPR value crosses the border of hemodynamic significance as compared to the value pre-valvular intervention. | Number of patients who have 1) a positive FFR/RFR/Pd/Pa/dPR value pre-valvular intervention, and negative FFR/RFR/Pd/Pa/dPR post-valvular intervention or 2) a negative FFR/RFR/Pd/Pa/dPR pre-valvular intervention, and positive FFR/RFR/Pd/Pa/dPR value post-valvular intervention. | Baseline | |
Other | The number of patients in whom the decision for coronary revascularization is altered when based on the post-procedural FFR value instead of angiographic stenosis severity. | Number of patients who have 1) post-valvular intervention FFR = 0.80 and diameter stenosis 50-70% or 2) post-valvular intervention FFR > 0.80 and diameter stenosis = 70%. | Baseline | |
Other | The diagnostic performance of vessel FFR (vFFR; an angiography-based FFR index) in the setting of valvular heart disease. | The vFFR pre-intervention will be validated against the FFR-value both pre- and post-intervention | Baseline | |
Primary | The change in the FFR value before and after TAVI | The impact of TAVI on FFR | Directly before and after the TAVI procedure (1 hour) | |
Primary | The change in the FFR value before and after TMVr | The impact of TMVr on FFR | Directly before and after the TMVr procedure (1 hour) | |
Secondary | The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr) | The impact of TAVI/TMVr on RFR | Directly before and after the TAVI/TMVr procedure (1 hour) | |
Secondary | The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr) | The impact of TAVI/TMVr on dPR | Directly before and after the TAVI/TMVr procedure (1 hour) | |
Secondary | The change in Pd/Pa before and after transcatheter valvular intervention (either TAVI or TMVr) | The impact of TAVI/TMVr on Pd/Pa | Directly before and after the TAVI/TMVr procedure (1 hour) | |
Secondary | The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr) | The impact of TAVI/TMVr on CFR | Directly before and after the TAVI/TMVr procedure (1 hour) | |
Secondary | The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr) | The impact of TAVI/TMVr on IMR | Directly before and after the TAVI/TMVr procedure (1 hour) | |
Secondary | The change in transvalvular gradient before and after transcatheter valvular intervention (either TAVI or TMVr) | The impact of TAVI/TMVr on the transvalvular gradient | Directly before and after the TAVI/TMVr procedure (1 hour) | |
Secondary | The change in left ventricular end-diastolic pressure (LVEDP) before and after transcatheter valvular intervention (either TAVI or TMVr) | The impact of TAVI/TMVr on the LVEDP | Directly before and after the TAVI/TMVr procedure (1 hour) | |
Secondary | The change in systemic aortic pressure before and after transcatheter valvular intervention (either TAVI or TMVr) | The impact of TAVI/TMVr on hemodynamics | Directly before and after the TAVI/TMVr procedure (1 hour) | |
Secondary | The change in heart rate before and after transcatheter valvular intervention (either TAVI or TMVr) | The impact of TAVI/TMVr on hemodynamics | Directly before and after the TAVI/TMVr procedure (1 hour) |
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