Trial Outcomes & Findings for HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve (NCT NCT02097420)
NCT ID: NCT02097420
Last Updated: 2025-02-11
Results Overview
The Kaplan-Meier method is a statistical method that summarizes the rate at which subjects survive or are free from a specified event. The method uses whether or not a subject had the specified event and their time to the specified event or the end of their follow-up to calculate the rate. Kaplan-Meier event rates with 95% confidence intervals would be calculated for overall survival. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included.
COMPLETED
NA
23 participants
12 months
2025-02-11
Participant Flow
A total of 23 subjects were enrolled at 15 investigational sites. Twenty (20) subjects were enrolled at 14 sites in the IDE cohort. Following completion of enrollment in the IDE cohort, 3 subjects were enrolled at 3 sites in the CAP cohort. All subjects enrolled in the study were followed for up to 5 years post-implant, or until the valve was retired/explanted, whichever occurred first. Enrollment was completed in the IDE cohort on 03 March 2017 and in the CAP cohort on 12 January 2018.
Participant milestones
| Measure |
Single Device Arm: Mitral Valve Replacement
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Single Device Arm: Mitral Valve Replacement
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Valve explanted
|
13
|
|
Overall Study
Other Reason
|
1
|
Baseline Characteristics
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Baseline characteristics by cohort
| Measure |
Single Device Arm: Mitral Valve Replacement
n=23 Participants
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Age, Continuous
|
7.6 Months
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
|
Weight
|
5.5 kilograms
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Height
|
60.5 centimeters
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Body Surface Area (BSA)
|
0.3 meter square
STANDARD_DEVIATION 0.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis population included the subjects who were available at the time of evaluation.
The Kaplan-Meier method is a statistical method that summarizes the rate at which subjects survive or are free from a specified event. The method uses whether or not a subject had the specified event and their time to the specified event or the end of their follow-up to calculate the rate. Kaplan-Meier event rates with 95% confidence intervals would be calculated for overall survival. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included.
Outcome measures
| Measure |
Single Device Arm: Mitral Valve Replacement
n=23 Participants
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth
|
71.0 percentage of participants
Interval 46.3 to 85.9
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis population included the 14 subjects who have completed the 12-month follow-up visit or until the valve was removed/replaced due to anatomical growth, whichever occurred first.
Peak gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.
Outcome measures
| Measure |
Single Device Arm: Mitral Valve Replacement
n=14 Participants
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography
|
19.8 mmHg
Standard Deviation 7.6
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis population included the 14 subjects who have completed the 12-month follow-up visit or until the valve was removed/replaced due to anatomical growth, whichever occurred first.
Mean gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.
Outcome measures
| Measure |
Single Device Arm: Mitral Valve Replacement
n=14 Participants
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography
|
7.9 mmHg
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis population included the 14 subjects who have completed the 12-month follow-up visit or until the valve was removed/replaced due to anatomical growth, whichever occurred first.
Valvular regurgitation as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.
Outcome measures
| Measure |
Single Device Arm: Mitral Valve Replacement
n=14 Participants
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
None
|
9 Participants
|
|
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
Trivial
|
3 Participants
|
|
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
Mild (1+)
|
1 Participants
|
|
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
Moderate (2+)
|
1 Participants
|
|
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
Moderately Severe (3+)
|
0 Participants
|
|
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
Severe (4+)
|
0 Participants
|
|
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
Present/Unknown
|
0 Participants
|
|
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
Unknown
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The analysis population included the subjects who were available at the time of evaluation.
Kaplan-Meier event rates with 95% confidence intervals would be calculated for valve-related adverse events. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included.
Outcome measures
| Measure |
Single Device Arm: Mitral Valve Replacement
n=23 Participants
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Primary Safety Endpoint: Rate of Total Valve-related Adverse Events
|
64.3 percentage of participants
Interval 39.0 to 81.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The analysis population included the 14 subjects who have completed the 12-month follow-up visit or until the valve was removed/replaced due to anatomical growth, whichever occurred first.
Percentiles would be summarized by visit interval from baseline to 12 months for all available data. Summary statistics including number of subjects, mean and standard deviation are provided at the 12-month visit.
Outcome measures
| Measure |
Single Device Arm: Mitral Valve Replacement
n=14 Participants
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Percentage Change in Height Percentiles From Baseline to 12 Months
|
59.4 Percentage of change
Standard Deviation 233.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The analysis population included the 14 subjects who have completed the 12-month follow-up visit or until the valve was removed/replaced due to anatomical growth, whichever occurred first.
Percentiles would be summarized by visit interval from baseline to 12 months for all available data.Summary statistics including number of subjects, mean, standard deviation, and difference between visits were used for this endpoint.
Outcome measures
| Measure |
Single Device Arm: Mitral Valve Replacement
n=14 Participants
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Percentage Change in Weight Percentiles From Baseline to 12 Months
|
370.8 Percentage of change
Standard Deviation 812.3
|
Adverse Events
Single Device Arm: Mitral Valve Replacement
Serious adverse events
| Measure |
Single Device Arm: Mitral Valve Replacement
n=23 participants at risk
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Blood and lymphatic system disorders
Abnormal Coagulation Parameter
|
8.7%
2/23 • 60 months
|
|
Blood and lymphatic system disorders
Anemias
|
8.7%
2/23 • 60 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
4.3%
1/23 • 60 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Atrial Flutter
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Atrial Tachycardia
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Cardiac Arrest
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Heart Block
|
8.7%
2/23 • 60 months
|
|
Cardiac disorders
Heart Failure
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
LVOT Resection with Resection of Subaortic Membrane Myotomy
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Left Ventricle Outflow Tract Observation w/ Subaortic Obstruction
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Left Ventricular Failure
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Mitral Valve Stenosis
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Moderate Left Ventricular (LV) Dysfunction
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Pseudoaneurysm on Left Ventricular Free Wall
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Tachycardia
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Third Degree Heart Block (Complete Heart Block)
|
13.0%
3/23 • 60 months
|
|
General disorders
Multiple Organ Failure
|
4.3%
1/23 • 60 months
|
|
General disorders
Other
|
17.4%
4/23 • 60 months
|
|
General disorders
Perivalvular Leak
|
4.3%
1/23 • 60 months
|
|
Infections and infestations
Bacterial Infections
|
4.3%
1/23 • 60 months
|
|
Infections and infestations
Bronchitis
|
4.3%
1/23 • 60 months
|
|
Infections and infestations
Common Cold/Upper Respiratory Tract Infection
|
4.3%
1/23 • 60 months
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • 60 months
|
|
Infections and infestations
Pneumonitis
|
4.3%
1/23 • 60 months
|
|
Infections and infestations
Sepsis
|
4.3%
1/23 • 60 months
|
|
Infections and infestations
Septic Shock Related to Presumed Pneumotosis/Nec
|
4.3%
1/23 • 60 months
|
|
Infections and infestations
Viral Syndrome
|
4.3%
1/23 • 60 months
|
|
Investigations
Abnormal Chest X-Ray
|
4.3%
1/23 • 60 months
|
|
Investigations
Abnormal Lab Value
|
4.3%
1/23 • 60 months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
1/23 • 60 months
|
|
Metabolism and nutrition disorders
Hypervolemia
|
4.3%
1/23 • 60 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.3%
1/23 • 60 months
|
|
Metabolism and nutrition disorders
Respiratory Acidosis
|
4.3%
1/23 • 60 months
|
|
Nervous system disorders
Generalized Tonic-Clonic Seizures
|
4.3%
1/23 • 60 months
|
|
Product Issues
Prosthetic Mitral Valve Dysfunction
|
4.3%
1/23 • 60 months
|
|
Product Issues
Thrombus
|
8.7%
2/23 • 60 months
|
|
Product Issues
Thrombus on Device
|
13.0%
3/23 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Edema
|
4.3%
1/23 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
8.7%
2/23 • 60 months
|
|
Surgical and medical procedures
G-Tube Procedure
|
4.3%
1/23 • 60 months
|
|
Vascular disorders
Acute Subdural Hematoma
|
4.3%
1/23 • 60 months
|
|
Vascular disorders
Bleeding
|
4.3%
1/23 • 60 months
|
|
Vascular disorders
Epistaxis
|
4.3%
1/23 • 60 months
|
|
Vascular disorders
Hematoma
|
4.3%
1/23 • 60 months
|
|
Vascular disorders
Intracerebral Haemorrhage
|
4.3%
1/23 • 60 months
|
|
Vascular disorders
Intraparenchymal Haemorrhage
|
4.3%
1/23 • 60 months
|
|
Vascular disorders
Subdural Haemorrhage
|
4.3%
1/23 • 60 months
|
Other adverse events
| Measure |
Single Device Arm: Mitral Valve Replacement
n=23 participants at risk
Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
|
|---|---|
|
Blood and lymphatic system disorders
Abnormal Coagulation Parameter
|
4.3%
1/23 • 60 months
|
|
Blood and lymphatic system disorders
Anemias
|
8.7%
2/23 • 60 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Atrial Tachycardia
|
8.7%
2/23 • 60 months
|
|
Cardiac disorders
Augmentation of Ascending Aorta with Pulmonary Homograft
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Elevated RV Pressure and Pulmonary Vasculature Resistance
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Infective/Bacterial Endocarditis
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Junctional Escape Rhythm/Intermittent Junctional Rhythm
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
LVOT Resection
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Mitral Valve Stenosis
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Progressive LVOT Obstruction
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
ST Segment Changes
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Sinus Node Dysfunction
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Third Degree Heart Block (Complete Heart Block)
|
4.3%
1/23 • 60 months
|
|
Cardiac disorders
Valve Stenosis
|
4.3%
1/23 • 60 months
|
|
General disorders
Fever
|
8.7%
2/23 • 60 months
|
|
General disorders
Other
|
21.7%
5/23 • 60 months
|
|
Infections and infestations
Common Cold/Upper Respiratory Tract Infection
|
4.3%
1/23 • 60 months
|
|
Investigations
Abnormal Lab Value
|
4.3%
1/23 • 60 months
|
|
Investigations
Elevated ALT Levels
|
4.3%
1/23 • 60 months
|
|
Investigations
Elevated AST Levels
|
4.3%
1/23 • 60 months
|
|
Investigations
Elevated Plasma Free Hemoglobin
|
4.3%
1/23 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.3%
1/23 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
4.3%
1/23 • 60 months
|
|
Surgical and medical procedures
Elective Procedure
|
4.3%
1/23 • 60 months
|
|
Surgical and medical procedures
Elective Surgery
|
4.3%
1/23 • 60 months
|
|
Surgical and medical procedures
Reoperation for Subaortic Stenosis
|
4.3%
1/23 • 60 months
|
|
Vascular disorders
Bleeding
|
4.3%
1/23 • 60 months
|
|
Vascular disorders
Cardiogenic Shock
|
4.3%
1/23 • 60 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER