Trial Outcomes & Findings for Portico and Navitor India Clinical Trial (NCT NCT05171712)
NCT ID: NCT05171712
Last Updated: 2026-04-15
Results Overview
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
COMPLETED
NA
30 participants
30 days post index procedure
2026-04-15
Participant Flow
Participant milestones
| Measure |
Portico Valve
Patients implanted with Portico Valve
|
Navitor Valve
Patients implanted with Navitor Valve
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
17
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Portico Valve
Patients implanted with Portico Valve
|
Navitor Valve
Patients implanted with Navitor Valve
|
|---|---|---|
|
Overall Study
Death
|
3
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.2 years
n=20 Participants
|
72.1 years
n=10 Participants
|
74.2 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
2 Participants
n=10 Participants
|
11 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
8 Participants
n=10 Participants
|
19 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
NYHA Functional Class
Class I
|
0 Participants
n=20 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
NYHA Functional Class
Class II
|
3 Participants
n=20 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=30 Participants
|
|
NYHA Functional Class
Class III
|
12 Participants
n=20 Participants
|
5 Participants
n=10 Participants
|
17 Participants
n=30 Participants
|
|
NYHA Functional Class
Class IV
|
5 Participants
n=20 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=30 Participants
|
|
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire
|
60.0 Scores on a scale
STANDARD_DEVIATION 13.4 • n=20 Participants
|
72.5 Scores on a scale
STANDARD_DEVIATION 9.2 • n=10 Participants
|
64.2 Scores on a scale
STANDARD_DEVIATION 13.4 • n=30 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedureThe outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
VARC-2 Defined Event Rate of All Cause Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedureThe outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
VARC-2 Defined Event Rate of Cardiovascular Mortality Rate (Percent of Subjects) at 30 Days From the Implant/Index Procedure
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedureMyocardial Infarction rate: percent of subjects who experienced a myocardial infarction within 30 days of the implant/index procedure
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
Myocardial Infarction Rate
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedureThe outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 30 Days From the Implant/Index Procedure
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedureThe outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
VARC-2 Defined Event Rate of Bleeding (Life-threatening, Major, Minor, Percent of Subjects) at 30 Days From the Implant/Index Procedure
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedureThe outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
VARC-2 Defined Event Rate of Acute Kidney Injury (Percent of Subjects) at 30 Days From the Implant/Index Procedure
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedureThe outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
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 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedureThe outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
VARC-2 Defined Event Rate of Coronary Obstruction (Percent of Subjects) at 30 Days From the Implant/Index Procedure
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedurePopulation: Patients were only analyzed if they did not have a permanent pacemaker at baseline. Patients who already had a permanent pacemaker implanted prior to undergoing a study procedure were excluded from this analysis.
The outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Outcome measures
| Measure |
Portico Valve
n=19 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=9 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
VARC-2 Defined Event Rate of Permanent Pacemaker Insertion (Percent of Subjects) at 30 Days From the Implant/Index Procedure
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During procedureDefined as absence of procedural mortality, correct positioning of a single Portico prosthetic heart valve into the proper anatomical location, no conversion to open surgery
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
Percentage of Subjects With Implant Success
|
19 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedurePopulation: Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have mean gradient assessed are not presented.
Units=mmHg
Outcome measures
| Measure |
Portico Valve
n=17 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
Echocardiographic Assessment of the Mean Aortic Gradient
|
9.6 mmHg
Standard Deviation 6.0
|
6.4 mmHg
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: 30 days post index procedurePopulation: Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have EOA assessed are not presented.
units = cm2
Outcome measures
| Measure |
Portico Valve
n=12 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=8 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
Echocardiographic Assessment of Effective Orifice Area (EOA)
|
1.6 cm2
Standard Deviation 0.5
|
1.8 cm2
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: 30 days post index procedurePopulation: Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have paravalvular leak assessed are not presented.
Reported as either none/trace, mild, moderate, or severe
Outcome measures
| Measure |
Portico Valve
n=14 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=9 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days.
None/trace
|
13 Participants
|
7 Participants
|
|
Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days.
Mild
|
1 Participants
|
2 Participants
|
|
Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days.
Moderate
|
0 Participants
|
0 Participants
|
|
Echocardiographic Assessment of Paravalvular Leak (PVL) Per VARC-2 Definitions at 30 Days.
Severe
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 9 months post index procedureThe outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
VARC-2 Defined Event Rate of All-Cause Mortality (Percent of Subjects) at 9 Months Post Implant/Index Procedure
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 9 months post index procedureThe outcome measures will be defined for all VARC-2 defined endpoints per the published VARC-2 definitions: 1-Kappetein et al. J Thorac Cardiovasc Surg: 2013;145:6-23.
Outcome measures
| Measure |
Portico Valve
n=20 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
VARC-2 Defined Event Rate of Stroke (Including Disabling and Non-disabling, Percent of Subjects) at 9 Months Post-implant/Index Procedure
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days post index procedurePopulation: Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have NYHA Class assessed are not presented.
Reported as the percent of subjects by NYHA class from baseline to 30 days and from baseline to 9 months; NYHA Class was measured as class I, II, III, or IV. Symptoms are worsening from I to IV.
Outcome measures
| Measure |
Portico Valve
n=17 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
New York Heart Association (NYHA) Functional Class
Class I
|
6 Participants
|
0 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class II
|
7 Participants
|
5 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class III
|
4 Participants
|
5 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class IV
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 9 months post index procedurePopulation: Reported as the percent of subjects by NYHA class from baseline to 30 days and from baseline to 9 months; NYHA Class was measured as class I, II, III, or IV. Symptoms are worsening from I to IV.
Analysis population for this measure includes only patients who had the assessment completed. Patients who completed a visit but were unable to have NYHA Class assessed are not presented.
Outcome measures
| Measure |
Portico Valve
n=16 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
New York Heart Association (NYHA) Functional Class
Class II
|
8 Participants
|
6 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class III
|
4 Participants
|
4 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class IV
|
0 Participants
|
0 Participants
|
|
New York Heart Association (NYHA) Functional Class
Class I
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPatients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group.
Outcome measures
| Measure |
Portico Valve
n=17 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire
|
76.8 Score on a scale
Standard Deviation 10.7
|
83.0 Score on a scale
Standard Deviation 6.3
|
PRIMARY outcome
Timeframe: 9 MonthsPatients are asked to rate their perception of their health on the day they complete the assessment on a scale of 0 to 100. A score of 100 means the patient has the best health they can imagine, and a score of 0 means the worst health they can imagine. The reported value is the average of all patient scores reported at the specified time point for the specified patient group.
Outcome measures
| Measure |
Portico Valve
n=17 Participants
Patients implanted with Portico Valve
|
Navitor Valve
n=10 Participants
Patients implanted with Navitor Valve
|
|---|---|---|
|
EuroQol 5-dimension, 5-level (EQ-5D-5L) Quality of Life Questionnaire
|
81.2 Score
Standard Deviation 12.1
|
84.7 Score
Standard Deviation 10.1
|
Adverse Events
Portico Valve
Navitor Valve
Serious adverse events
| Measure |
Portico Valve
n=20 participants at risk
Patients implanted with Portico Valve
|
Navitor Valve
n=10 participants at risk
Patients implanted with Navitor Valve
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Cardiac disorders
Cardiac performation
|
5.0%
1/20 • Number of events 2 • 9 months
|
0.00%
0/10 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Cardiac disorders
Valve mirgation
|
10.0%
2/20 • Number of events 2 • 9 months
|
0.00%
0/10 • 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
Other adverse events
| Measure |
Portico Valve
n=20 participants at risk
Patients implanted with Portico Valve
|
Navitor Valve
n=10 participants at risk
Patients implanted with Navitor Valve
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture in femur
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Immune system disorders
HBsAg reactive status
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Gastrointestinal disorders
Loose stool
|
10.0%
2/20 • Number of events 2 • 9 months
|
0.00%
0/10 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Nervous system disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Number of events 1 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Vascular disorders
Vascular access site related complication
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Vascular disorders
Vessel dissection
|
5.0%
1/20 • Number of events 1 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Cardiac disorders
Hypertension
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
General disorders
Pedal edema
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough and expectoration
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Diabetes (poorly controlled)
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
General disorders
Fever and chills
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Nervous system disorders
Supracranial palsy and dementia
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
General disorders
Sialorrhea and rigidity
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Gastroesoopgeal reflux disease
|
0.00%
0/20 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Cardiac disorders
Left bundle branch block
|
10.0%
2/20 • Number of events 2 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral lower limb pain
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Gastrointestinal disorders
Bleeding (per rectum)
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
Blood and lymphatic system disorders
Blood transfusion
|
5.0%
1/20 • Number of events 1 • 9 months
|
0.00%
0/10 • 9 months
|
|
General disorders
Decreased appetite
|
5.0%
1/20 • Number of events 1 • 9 months
|
10.0%
1/10 • Number of events 1 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor will have the right to publish overall study results. Investigators may publish results from their respective participating site per their discretion but only after the multi-center publication is published or 12 months have passed from the study conclusion without a multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER