N/A
Completed N=30
Portico and Navitor India Clinical Trial
Aortic Valve Stenosis · Aortic Valve Failure · Aortic Insufficiency · Aortic Stenosis
Source: ClinicalTrials.gov NCT05171712 ↗
Enrolled (actual)
30
Serious AEs
26.7%
Results posted
Apr 2026
Primary outcomePrimary: VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure — 3; 0 Participants
Summary
The objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure |
3; 0 | — |
| PRIMARY VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure |
2; 0 | — |
| PRIMARY Myocardial Infarction Rate |
0; 0 | — |
| PRIMARY VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 30 Days From the Implant/Index Procedure |
0; 0 | — |
| PRIMARY VARC-2 Defined Event Rate of Bleeding (Life-threatening, Major, Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure |
2; 0 | — |
| PRIMARY VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/Index Procedure |
0; 0 | — |
| PRIMARY VARC-2 Defined Event Rate of Vascular Access Site and Access-related Complications (Major and Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure |
2; 1 | — |
| PRIMARY VARC-2 Defined Event Rate of Coronary Obstruction (Percent of Subjects) at 30 Days From the Implant/Index Procedure |
0; 0 | — |
| PRIMARY VARC-2 Defined Event Rate of Permanent Pacemaker Insertion (Percent of Subjects) at 30 Days From the Implant/Index Procedure |
2; 0 | — |
| PRIMARY Percentage of Subjects With Implant Success |
19; 10 | — |
| PRIMARY Echocardiographic Assessment of the Mean Aortic Gradient |
9.6; 6.4 | — |
| PRIMARY Echocardiographic Assessment of Effective Orifice Area (EOA) |
1.6; 1.8 | — |
| PRIMARY Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days. |
13; 7; 1; 2; 0; 0 | — |
| PRIMARY VARC-2 Defined Event Rate of All-Cause Mortality (Percent of Subjects) at 9 Months Post Implant/Index Procedure |
3; 0 | — |
| PRIMARY VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 9 Months Post-implant/Index Procedure |
0; 0 | — |
| PRIMARY New York Heart Association (NYHA) Functional Class |
4; 0; 8; 6; 4; 4 | — |
| PRIMARY New York Heart Association (NYHA) Functional Class |
4; 0; 8; 6; 4; 4 | — |
| PRIMARY EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire |
81.2; 84.7 | — |
| PRIMARY EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire |
81.2; 84.7 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
- Are >60 years of age in host country, have severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), at high or extreme surgical risk and have been identified as a candidate for a Portico or Navitor valve implant.
- Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.
Exclusion Criteria
- Have tested positive for the Corona Virus Disease 2019 (COVID-19) virus at any time AND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lung tissue, etc.)
- Have sepsis, including active endocarditis
- Have any evidence of left ventricular or atrial thrombus
- Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
- Have a non-calcified aortic annulus
- Have congenital bicuspid or unicuspid leaflet configuration
- Are unable to tolerate antiplatelet/anticoagulant therapy
- Are pregnant at the time of signing informed consent
- Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)
Data sourced from ClinicalTrials.gov (NCT05171712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.