Coronary Physiology Peri-Transcatheter Left-sided Valvular interventions in Patients with Severe Aortic Stenosis or Mitral Regurgitation

Coronary Physiology Peri-Transcatheter Left-sided Valvular interventions in Patients with Severe Aortic Stenosis or Mitral Regurgitation - POTUS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53992

Enrollment

150

Registered

2021-02-16

Start date

2021-03-22

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease valvular heart disease

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18. 2. a. TAVI Cohort: severe aortic valve stenosis for which TAVI is scheduled after discussion in the Heart Team. b. TVMR Cohort: severe functional mitral regurgitation for which TVMR is scheduled after discussion in the Heart Team. 3. At least intermediate coronary artery disease, defined as 50 - 99% DS in a vessel >=2.5 mm. 4. Elective procedure. 5. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. TAVI cohort: height coronary ostia

Design outcomes

Primary

Measure	Time frame
The change in the FFR value before and after transcatheter left-sided valvular intervention (i.e. TAVI or TMVR).	—

Secondary

Measure	Time frame
The change in • RFR; • Pd/Pa; • CFR; • IMR; • dPR; • transvalvular gradient; • LVEDP; • Systemic aortic pressure; • Heart rate; before and after transcatheter valvular intervention (either TAVI or TMVR). Differences in changes in the physiology indices mentioned above between the TAVI cohort and the TMVR cohort. 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. The number of patients in whom the decision for coronary revascularization is changed when based on the post-procedural FFR value instead of angiographic stenosis severity. The diagnostic performance of a new physiological index that is corrected for the hemodynamic changes induced by either aortic stenosis or mitral regurgitation. (i.e. sensitivity, specificity, agreement, positive predictive value, negative predictive value, area under the curve of the receiver operating curve). The diagnostic performance of vFFR in the setting of valvular heart disease. The vFFR pre-intervention will be validated against the FFR-value both pre- and post-intervention (i.e. sensitivity, specificity, agreement, positive predictive value, negative predictive value, area under the curve of the receiver operating curve).	—

Measure

Time frame

The change in • RFR; • Pd/Pa; • CFR; • IMR; • dPR; • transvalvular gradient; • LVEDP; • Systemic aortic pressure; • Heart rate; before and after transcatheter valvular intervention (either TAVI or TMVR). Differences in changes in the physiology indices mentioned above between the TAVI cohort and the TMVR cohort. 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. The number of patients in whom the decision for coronary revascularization is changed when based on the post-procedural FFR value instead of angiographic stenosis severity. The diagnostic performance of a new physiological index that is corrected for the hemodynamic changes induced by either aortic stenosis or mitral regurgitation. (i.e. sensitivity, specificity, agreement, positive predictive value, negative predictive value, area under the curve of the receiver operating curve). The diagnostic performance of vFFR in the setting of valvular heart disease. The vFFR pre-intervention will be validated against the FFR-value both pre- and post-intervention (i.e. sensitivity, specificity, agreement, positive predictive value, negative predictive value, area under the curve of the receiver operating curve).

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Countries

Netherlands

Outcome results