Trial Outcomes & Findings for Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve (NCT NCT00630916)
NCT ID: NCT00630916
Last Updated: 2011-09-22
Results Overview
Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring \>30 days after valve implant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
756 participants
Primary outcome timeframe
Late postoperative
Results posted on
2011-09-22
Participant Flow
Participant milestones
| Measure |
Mitroflow Aortic Pericardial Valve
Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
|
|---|---|
|
Overall Study
STARTED
|
756
|
|
Overall Study
Study Cohort
|
699
|
|
Overall Study
COMPLETED
|
546
|
|
Overall Study
NOT COMPLETED
|
210
|
Reasons for withdrawal
| Measure |
Mitroflow Aortic Pericardial Valve
Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
|
|---|---|
|
Overall Study
Death
|
110
|
|
Overall Study
Explant
|
8
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
30
|
|
Overall Study
Protocol Violation
|
7
|
|
Overall Study
Physician Decision
|
47
|
|
Overall Study
Lack of Efficacy
|
3
|
Baseline Characteristics
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
Baseline characteristics by cohort
| Measure |
Mitroflow Aortic Pericardial Valve
n=699 Participants
Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
603 Participants
n=5 Participants
|
|
Age Continuous
|
74.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
302 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
397 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
556 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
143 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Late postoperativePopulation: Cumulative follow-up in years occurring post 30 days
Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring \>30 days after valve implant.
Outcome measures
| Measure |
Mitroflow Aortic Pericardial Valve
n=1474 patient-years
Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
|
|---|---|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
All mortality
|
7.1 Percent occurrence per patient-year
Interval 5.8 to 8.6
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Valve-related mortality
|
1.27 Percent occurrence per patient-year
Interval 0.78 to 1.96
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Structural valve deterioration
|
0.21 Percent occurrence per patient-year
Interval 0.06 to 0.56
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Major anticoagulant-related bleeding
|
0.56 Percent occurrence per patient-year
Interval 0.27 to 1.06
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Thromboembolism
|
1.34 Percent occurrence per patient-year
Interval 0.83 to 2.05
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Major thromboembolic event
|
0.49 Percent occurrence per patient-year
Interval 0.22 to 0.97
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Valve thrombosis
|
0 Percent occurrence per patient-year
Interval 0.0 to 0.17
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Endocarditis
|
1.41 Percent occurrence per patient-year
Interval 0.89 to 2.13
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Non-structural valve dysfunction
|
0.75 Percent occurrence per patient-year
Interval 0.4 to 1.29
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Perivalvular leak
|
0.63 Percent occurrence per patient-year
Interval 0.31 to 1.16
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Hemolysis
|
0 Percent occurrence per patient-year
Interval 0.0 to 0.17
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Valve reoperation
|
0.85 Percent occurrence per patient-year
Interval 0.46 to 1.43
|
|
Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair
Valve explant
|
0.77 Percent occurrence per patient-year
Interval 0.41 to 1.34
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Patients with 12 month hemodynamic evaluations
Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size.
Outcome measures
| Measure |
Mitroflow Aortic Pericardial Valve
n=544 Participants
Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
|
|---|---|
|
Mean Gradient
Valve Size 19
|
13.4 mmHg
Standard Deviation 5
|
|
Mean Gradient
Valve Size 21
|
11.4 mmHg
Standard Deviation 4.4
|
|
Mean Gradient
Valve Size 23
|
10.5 mmHg
Standard Deviation 4.2
|
|
Mean Gradient
Valve Size 25
|
8.6 mmHg
Standard Deviation 3.3
|
|
Mean Gradient
Valve Size 27
|
7.3 mmHg
Standard Deviation 2.7
|
|
Mean Gradient
Valve Size 29
|
7.3 mmHg
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: 12 monthsEffective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size.
Outcome measures
| Measure |
Mitroflow Aortic Pericardial Valve
n=544 Participants
Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
|
|---|---|
|
Effective Orifice Area
Valve Size 19
|
1.1 cm^2
Standard Deviation 0.2
|
|
Effective Orifice Area
Valve Size 21
|
1.2 cm^2
Standard Deviation 0.3
|
|
Effective Orifice Area
Valve Size 23
|
1.4 cm^2
Standard Deviation 0.3
|
|
Effective Orifice Area
Valve Size 25
|
1.6 cm^2
Standard Deviation 0.3
|
|
Effective Orifice Area
Valve Size 27
|
1.8 cm^2
Standard Deviation 0.3
|
|
Effective Orifice Area
Valve Size 29
|
2 cm^2
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 12 monthsMeasure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.
Outcome measures
| Measure |
Mitroflow Aortic Pericardial Valve
n=557 Participants
Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
|
|---|---|
|
Aortic Valve Regurgitation
None
|
74.3 Percent of participants
|
|
Aortic Valve Regurgitation
Trace
|
16.2 Percent of participants
|
|
Aortic Valve Regurgitation
Mild
|
8.6 Percent of participants
|
|
Aortic Valve Regurgitation
Moderate
|
0.9 Percent of participants
|
|
Aortic Valve Regurgitation
Severe
|
0 Percent of participants
|
Adverse Events
Mitroflow Aortic Pericardial Valve
Serious events: 351 serious events
Other events: 430 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mitroflow Aortic Pericardial Valve
n=699 participants at risk
Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.0%
21/699 • Number of events 24 • All postop serious adverse events
|
|
Vascular disorders
Bleeding
|
2.1%
15/699 • Number of events 16 • All postop serious adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
2.9%
20/699 • Number of events 20 • All postop serious adverse events
|
|
Cardiac disorders
Cardiac arrest
|
1.9%
13/699 • Number of events 13 • All postop serious adverse events
|
|
Cardiac disorders
Cardiac arrhythmias
|
3.4%
24/699 • Number of events 24 • All postop serious adverse events
|
|
Infections and infestations
Endocarditis
|
2.9%
20/699 • Number of events 20 • All postop serious adverse events
|
|
Gastrointestinal disorders
GI bleeding
|
3.1%
22/699 • Number of events 22 • All postop serious adverse events
|
|
Gastrointestinal disorders
GI infection
|
0.86%
6/699 • Number of events 6 • All postop serious adverse events
|
|
Cardiac disorders
Heart failure
|
8.4%
59/699 • Number of events 69 • All postop serious adverse events
|
|
Blood and lymphatic system disorders
Hemic & Lymphatic
|
1.7%
12/699 • Number of events 12 • All postop serious adverse events
|
|
Metabolism and nutrition disorders
Metabolic & Nutritional
|
2.3%
16/699 • Number of events 16 • All postop serious adverse events
|
|
Gastrointestinal disorders
Miscellaneous GI disorders
|
4.6%
32/699 • Number of events 33 • All postop serious adverse events
|
|
Infections and infestations
Miscellaneous infections
|
4.9%
34/699 • Number of events 36 • All postop serious adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculo-skeletal disorders
|
4.1%
29/699 • Number of events 32 • All postop serious adverse events
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
10/699 • Number of events 12 • All postop serious adverse events
|
|
Nervous system disorders
Nervous system
|
2.6%
18/699 • Number of events 18 • All postop serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
26/699 • Number of events 31 • All postop serious adverse events
|
|
Renal and urinary disorders
Renal failure / insufficiency
|
4.0%
28/699 • Number of events 29 • All postop serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure / disorder
|
5.0%
35/699 • Number of events 35 • All postop serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infections
|
5.0%
35/699 • Number of events 36 • All postop serious adverse events
|
|
Infections and infestations
Sepsis / bacteremia
|
4.1%
29/699 • Number of events 29 • All postop serious adverse events
|
|
Vascular disorders
Thromboembolic events
|
2.3%
16/699 • Number of events 17 • All postop serious adverse events
|
|
Renal and urinary disorders
UTI
|
1.3%
9/699 • Number of events 9 • All postop serious adverse events
|
Other adverse events
| Measure |
Mitroflow Aortic Pericardial Valve
n=699 participants at risk
Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
|
|---|---|
|
Cardiac disorders
Arrhythmias
|
5.2%
36/699 • Number of events 37 • All postop serious adverse events
|
|
Cardiac disorders
Atrial fibrillation
|
22.3%
156/699 • Number of events 168 • All postop serious adverse events
|
|
Cardiac disorders
Heart failure
|
5.0%
35/699 • Number of events 37 • All postop serious adverse events
|
|
Infections and infestations
Miscellaneous infections
|
7.6%
53/699 • Number of events 57 • All postop serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.6%
60/699 • Number of events 61 • All postop serious adverse events
|
|
Renal and urinary disorders
Renal failure / insufficiency
|
5.7%
40/699 • Number of events 42 • All postop serious adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infections
|
6.4%
45/699 • Number of events 47 • All postop serious adverse events
|
|
Renal and urinary disorders
Urinary tract infection
|
9.6%
67/699 • Number of events 77 • All postop serious adverse events
|
Additional Information
Director of Clinical and Medical Affairs
Sorin Group USA
Phone: 512-435-3602
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60