Trial Outcomes & Findings for ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent (NCT NCT03130777)
NCT ID: NCT03130777
Last Updated: 2025-09-25
Results Overview
Number of patients with acute PDS success, defined as a non-hierarchical composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE) * Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
24 hours
Results posted on
2025-09-25
Participant Flow
Participant milestones
| Measure |
TPVR - Main Cohort
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
TPVR - PDS Registry
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
25
|
|
Overall Study
COMPLETED
|
60
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
TPVR - Main Cohort
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
TPVR - PDS Registry
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Did not meet eligibility criteria
|
1
|
0
|
Baseline Characteristics
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Baseline characteristics by cohort
| Measure |
TPVR - Main Cohort
n=61 Participants
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
TPVR - PDS Registry
n=25 Participants
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 16.44 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 17.23 • n=7 Participants
|
29.4 years
STANDARD_DEVIATION 16.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
43 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple Races
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Valve implant population, 1 subject did not complete the 6 month follow up.
Number of patients with THV dysfunction, defined as a non-hierarchical composite of: * RVOT/PV Reintervention * Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE) * Mean RVOT/PV Gradient \>= 35mmHg via TTE
Outcome measures
| Measure |
TPVR - Main Cohort
n=59 Participants
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
|---|---|
|
Main Cohort: THV Dysfunction
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Attempted implant population
Number of patients with acute PDS success, defined as a non-hierarchical composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE) * Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation
Outcome measures
| Measure |
TPVR - Main Cohort
n=25 Participants
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
|---|---|
|
PDS Registry: Acute PDS Success
|
22 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Valve implant population
Number of patients with improvement in total pulmonary regurgitation
Outcome measures
| Measure |
TPVR - Main Cohort
n=60 Participants
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
|---|---|
|
Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline
|
60 Participants
|
Adverse Events
TPVR - Main Cohort
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
TPVR - PDS Registry
Serious events: 5 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TPVR - Main Cohort
n=61 participants at risk
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
TPVR - PDS Registry
n=25 participants at risk
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/61 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/61 • 6 months
|
4.0%
1/25 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pericardial haemorrhage
|
1.6%
1/61 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Cardiac disorders
Tricuspid valve incompetence
|
3.3%
2/61 • Number of events 2 • 6 months
|
8.0%
2/25 • Number of events 2 • 6 months
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/61 • 6 months
|
8.0%
2/25 • Number of events 2 • 6 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/61 • 6 months
|
4.0%
1/25 • Number of events 1 • 6 months
|
|
General disorders
Prosthetic cardiac valve thrombosis
|
1.6%
1/61 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
General disorders
Vascular stent thrombosis
|
1.6%
1/61 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/61 • 6 months
|
4.0%
1/25 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.6%
1/61 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.00%
0/61 • 6 months
|
4.0%
1/25 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Venous injury
|
1.6%
1/61 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Investigations
Transvalvular pressure gradient increased
|
1.6%
1/61 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Product Issues
Device dislocation
|
1.6%
1/61 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Product Issues
Lead dislodgement
|
1.6%
1/61 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/61 • 6 months
|
4.0%
1/25 • Number of events 1 • 6 months
|
|
Vascular disorders
Pelvic venous thrombosis
|
1.6%
1/61 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
Other adverse events
| Measure |
TPVR - Main Cohort
n=61 participants at risk
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
TPVR - PDS Registry
n=25 participants at risk
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).
Edwards Alterra Adaptive Prestent with SAPIEN 3 THV: The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
|
|---|---|---|
|
Cardiac disorders
Tricuspid valve incompetence
|
6.6%
4/61 • 6 months
|
0.00%
0/25 • 6 months
|
|
Cardiac disorders
Venricular extrasystoles
|
16.4%
10/61 • 6 months
|
16.0%
4/25 • 6 months
|
|
Cardiac disorders
Ventricular tachycardia
|
24.6%
15/61 • 6 months
|
8.0%
2/25 • 6 months
|
|
General disorders
Chest discomfort
|
9.8%
6/61 • 6 months
|
0.00%
0/25 • 6 months
|
|
General disorders
Chest pain
|
13.1%
8/61 • 6 months
|
24.0%
6/25 • 6 months
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
9.8%
6/61 • 6 months
|
8.0%
2/25 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
6.6%
4/61 • 6 months
|
0.00%
0/25 • 6 months
|
|
Product Issues
Device breakage
|
8.2%
5/61 • 6 months
|
12.0%
3/25 • 6 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/61 • 6 months
|
8.0%
2/25 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place