Trial Outcomes & Findings for Engager Direct Aortic Clinical Study (NCT NCT01789567)
NCT ID: NCT01789567
Last Updated: 2018-07-26
Results Overview
Acute delivery system success, defined as bioprosthesis deployed in anatomically correct position and freedom from delivery system related complications at the end of the procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Within 30 days of implant procedure
Results posted on
2018-07-26
Participant Flow
Participant milestones
| Measure |
Engager™ Aortic Valve
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Engager™ Aortic Valve
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
|
|---|---|
|
Overall Study
Death
|
6
|
Baseline Characteristics
Engager Direct Aortic Clinical Study
Baseline characteristics by cohort
| Measure |
Engager™ Aortic Valve
n=20 Participants
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
80.6 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
|
STS Risk of Mortality
|
5.9 %
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Peripheral vascular disease
Peripheral vascular disease
|
10 participants
n=5 Participants
|
|
Peripheral vascular disease
No peripheral vascular disease
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 30 days of implant procedurePopulation: Analysis for this endpoint includes subjects with an implant attempt.
Acute delivery system success, defined as bioprosthesis deployed in anatomically correct position and freedom from delivery system related complications at the end of the procedure.
Outcome measures
| Measure |
Engager™ Aortic Valve
n=20 Participants
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
|
|---|---|
|
Acute Delivery System Success
|
95.0 percentage of participants
Interval 75.1 to 99.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post-procedurePopulation: Analysis for this endpoint includes subjects with an implant attempt.
Device success is a composite of: Absence of 30-day in-hospital death Correct position of the device within the aortic annular region Intended performance of the bioprosthesis (no patient-prosthesis mismatch, mean aortic gradient \<20 mmHg or peak velocity \<3 m/s at discharge, and no moderate or severe prosthetic valve regurgitation)
Outcome measures
| Measure |
Engager™ Aortic Valve
n=20 Participants
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
|
|---|---|
|
Device Success According to VARC2
|
15.0 percentage of participants
Interval 3.2 to 37.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-days post-procedurePopulation: Analysis for this endpoint includes subjects with an implant attempt.
Percentage of Participants with any of the following Safety Events within 30-days post-procedure: All-cause mortality All stroke Life-threatening bleeding Acute kidney injury (stage 2-3) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)
Outcome measures
| Measure |
Engager™ Aortic Valve
n=20 Participants
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
|
|---|---|
|
Composite 30-day Safety Endpoint According to VARC2
|
25.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-days post-procedurePopulation: Analysis for this endpoint includes subjects at risk (or alive and in study) at 30 days.
Percentage of Participants with any of the following Safety Events after 30-days post-procedure: All-cause mortality All stroke Hospitalization for valve-related symptoms or worsening congestive heart failure
Outcome measures
| Measure |
Engager™ Aortic Valve
n=18 Participants
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
|
|---|---|
|
Composite Clinical Efficacy Endpoint After 30 Days According to VARC2
|
94.4 percentage of participants
|
Adverse Events
Engager™ Aortic Valve
Serious events: 20 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Engager™ Aortic Valve
n=20 participants at risk
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
|
|---|---|
|
Blood and lymphatic system disorders
Anemia (Hgb<10g or Hct<30%)
|
20.0%
4/20 • Number of events 4 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Congestive heart failure
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Atrial flutter
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Atrio-ventricular block, 3 degree
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Ventricular fibrillation
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Other implantation/catheterization
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Atrial fibrillation
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Other cardiac event
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Gastrointestinal disorders
Life threatening or disabling bleed event
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Gastrointestinal disorders
Major bleeding event
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Gastrointestinal disorders
Other gastrointestinal
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
General disorders
Multi organ failure
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
General disorders
Other
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
General disorders
Sepsis, confirmed (positive blood culture)
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Infections and infestations
Other gastrointestinal
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Injury, poisoning and procedural complications
Life threatening or disabling bleed event
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Injury, poisoning and procedural complications
Major bleeding event
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Injury, poisoning and procedural complications
Misplacement of the Engager Valve
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Injury, poisoning and procedural complications
Other
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Injury, poisoning and procedural complications
Perforation of the heart
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Investigations
Other
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer/malignancy
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Nervous system disorders
Transient ischemic attack
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Psychiatric disorders
Other
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Renal and urinary disorders
Acute kidney injury: stage 3
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
5/20 • Number of events 5 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Surgical and medical procedures
Life threatening or disabling bleed event
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Vascular disorders
Major ascending aortic dissection
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Vascular disorders
Other
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
Other adverse events
| Measure |
Engager™ Aortic Valve
n=20 participants at risk
Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
Engager™ aortic valve: Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
|
|---|---|
|
Blood and lymphatic system disorders
Anemia (Hgb<10g or Hct<30%)
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Blood and lymphatic system disorders
Hemolysis: minor
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Blood and lymphatic system disorders
Other hematologic/oncologic
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
4/20 • Number of events 4 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Atrio-ventricular block, 1 degree
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Congestive heart failure
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
LBBB
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Other arrhythmia
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Other respiratory/pulmonary
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Pericardial effusion, non-hemorrhagic
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Sinus bradycardia (<50 bpm)
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Ventricular premature beats
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Cardiac disorders
Ventricular tachycardia
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Endocrine disorders
Other
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Gastrointestinal disorders
Minor bleeding event
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Gastrointestinal disorders
Other
|
10.0%
2/20 • Number of events 4 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Gastrointestinal disorders
Other gastrointestinal
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
General disorders
Other
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Infections and infestations
Other
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Infections and infestations
Other infection
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Infections and infestations
Pneumonia
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Infections and infestations
Urinary tract infection
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Injury, poisoning and procedural complications
Other
|
10.0%
2/20 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Investigations
Congestive heart failure
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Investigations
Other
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Investigations
Other gastrointestinal
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Investigations
Other renal
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Metabolism and nutrition disorders
Other
|
5.0%
1/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Musculoskeletal and connective tissue disorders
Other
|
20.0%
4/20 • Number of events 4 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Nervous system disorders
Other central nervous system
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Psychiatric disorders
Other
|
20.0%
4/20 • Number of events 4 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Renal and urinary disorders
Other
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Renal and urinary disorders
Renal insufficiency
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm/asthma
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Minor bleeding event
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory/pulmonary
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
5/20 • Number of events 6 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Skin and subcutaneous tissue disorders
Other
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Vascular disorders
Other
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
|
Vascular disorders
Other cardiac event
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
SAEs were adjudicated per VARC2 definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60