Post-Infarction Ventricular Septal Defect
Conditions
Brief summary
FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder.
Detailed description
This is a multi-center, observational study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder for use in transcatheter closure of muscular ventricular septal defects following a myocardial infarction in the post approval setting. The study has five endpoints (safety: acute and chronic survival; effectiveness: technical success, acute and chronic closure).Two cohorts will be utilized to obtain study endpoint data. The first cohort will be comprised of all available Emergency and Compassionate PIVSD Occluder subject data from 2011 until the end of 2016 and these data will be used to determine technical success and acute survival. The second cohort of thirty subjects will be comprised of patients who are successfully implanted with a PIVSD Occluder from 2011 onward at activated study centers. The index procedure must have occurred \>6 months prior to enrollment. Subject identification will occur until data on a minimum of 30 subjects with PIVSD Occluders for post myocardial infarct VSD and post-procedure echocardiogram available for evaluation of residual shunt by the echocardiography core laboratory have been enrolled. The thirty subject cohort data will be used to determine acute closure, chronic closure, and chronic survival endpoints. The study will be conducted at up to 50 centers in the U.S. The expected duration of enrollment is approximately 4 years. The total duration of the clinical study is expected to be 4.5 years.
Interventions
DEVICEAMPLATZER™ Post-infarct Muscular VSD Occluder
The AMPLATZER™ PIVSD Occluder is intended for percutaneous transcatheter closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
First Cohort: Patients who have undergone an attempt to close a post-infarct VSD using the AMPLATZER™ PIVSD Occluder via Emergency and Compassionate 2011 until the end of 2016. Second Cohort: * Over 18 years old * Patients who have previously been successfully implanted with the AMPLATZER™ PIVSD Occluder * For living subjects, the subject or subject's legally authorized representative has provided consent to participate in this study * Subject's post-procedure echocardiogram is evaluable and can be sent to the echocardiography core laboratory for residual shunt assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Endpoint 1: Technical Success | End of Implant Procedure | Technical success occurs when a subject is successfully implanted with a PIVSD device in the ventricular septal defect. An implant attempt occurs when the delivery system is inserted in the subject's vasculature. |
| Effectiveness Endpoint 2: Acute Closure | Up to 7 days post-procedure | Acute closure is defined as the absence of a residual shunt ≥3 mm, and will be assessed based on an echocardiogram obtained immediately after the successful deployment of the device and up to 7 days post-procedure. |
| Effectiveness Endpoint 3: Chronic Closure | 6 months or later following a PIVSD device implant through study completion, an average of 1 year | Chronic closure is defined as the absence of a residual shunt ≥3 mm at 6 months or later. |
| Safety Endpoint 1: Acute Survival | Equal to or greater than 24 hours following an attempted PIVSD device implant through study completion, up to 9.7 years post-procedure | Acute survival is defined as survival for at least 24 hours following an attempted PIVSD device implant. |
| Safety Endpoint 2: Chronic Survival | Equal to or greater than 183 days from the time of first successful implant through study completion, up to 9.7 years post-procedure | Chronic survival is defined as survival for at least 183 days from the time of first successful implant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amplatzer Post-Infarct Muscular VSCD Occluder Humanitarian Device Exemption Post-Approval Study Cohort 1: All available Emergency and Compassionate PIVSD Occluder subject data from 2011 until the end of 2016 will be utilized to determine technical success and acute survival. All subjects belonging to this cohort must have undergone an attempt to close a post-infarct VSD using the AMPLATZER™ PIVSD Occluder.
Cohort 2: This cohort will consist of subjects over the age of 18 years who have previously been successfully implanted with the PIVSD Occluder and
* For living subjects, the subject or subject's legally authorized representative has provided consent to participate in this study.
* Subject's post-procedure echocardiogram is evaluable and can be sent to the echocardiography core laboratory for residual shunt assessment.
Therefore, this cohort will be composed of retrospectively enrolled subjects. This cohort will be utilized to determine acute and chronic closure and chronic survival.
AMPLATZER™ Post-infarct Muscular VSD Occluder: The AMPLATZER™ PIVSD Occluder is intended for percutaneous transcatheter closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates. | 131 |
| Total | 131 |
Baseline characteristics
| Characteristic | Amplatzer Post-Infarct Muscular VSCD Occluder Humanitarian Device Exemption Post-Approval Study | — |
|---|---|---|
| Age, Continuous Cohort 1 | 68.6 years STANDARD_DEVIATION 11.9 | — |
| Age, Continuous Cohort 2 | 66.4 years STANDARD_DEVIATION 10.9 | — |
| BMI Cohort 1 | — | — kg/m^2 |
| BMI Cohort 2 | 28.34 kg/m^2 STANDARD_DEVIATION 5.62 | — |
| Ethnicity (NIH/OMB) Cohort 2 Hispanic or Latino | 2 Participants | — |
| Ethnicity (NIH/OMB) Cohort 2 Not Hispanic or Latino | 25 Participants | — |
| Ethnicity (NIH/OMB) Cohort 2 Unknown or Not Reported | 5 Participants | — |
| Height (cm) Cohort 1 | — | — cm |
| Height (cm) Cohort 2 | 168.47 cm STANDARD_DEVIATION 9.3 | — |
| Location of MI Cohort 1 Anterior (LAD) | 39 Participants | — |
| Location of MI Cohort 1 Lateral (Cicumflex) | 2 Participants | — |
| Location of MI Cohort 1 Posterior/Inferior (RCA) | 47 Participants | — |
| Location of MI Cohort 1 Unknown | 11 Participants | — |
| Location of MI Cohort 2 Anterior (LAD) | 14 Participants | — |
| Location of MI Cohort 2 Lateral (Cicumflex) | 1 Participants | — |
| Location of MI Cohort 2 Posterior/Inferior (RCA) | 16 Participants | — |
| Location of MI Cohort 2 Unknown | 1 Participants | — |
| Medical History Cohort 1 | — | — Participants |
| Medical History Cohort 2 - Diabetes | 10 Participants | — |
| Medical History Cohort 2 - History of Smoking | 18 Participants | — |
| Medical History Cohort 2 - Hyperlipidemia | 19 Participants | — |
| Medical History Cohort 2 - Hypertension | 21 Participants | — |
| Race (NIH/OMB) Cohort 2 American Indian or Alaska Native | 0 Participants | — |
| Race (NIH/OMB) Cohort 2 Asian | 0 Participants | — |
| Race (NIH/OMB) Cohort 2 Black or African American | 1 Participants | — |
| Race (NIH/OMB) Cohort 2 More than one race | 0 Participants | — |
| Race (NIH/OMB) Cohort 2 Native Hawaiian or Other Pacific Islander | 0 Participants | — |
| Race (NIH/OMB) Cohort 2 Unknown or Not Reported | 4 Participants | — |
| Race (NIH/OMB) Cohort 2 White | 27 Participants | — |
| Region of Enrollment United States Cohort 1 | 99 Participants | — |
| Region of Enrollment United States Cohort 2 | 32 Participants | — |
| Sex: Female, Male Cohort 1 Female | 46 Participants | — |
| Sex: Female, Male Cohort 1 Male | 53 Participants | — |
| Sex: Female, Male Cohort 2 Female | 15 Participants | — |
| Sex: Female, Male Cohort 2 Male | 17 Participants | — |
| Weight (kg) Cohort 1 | — | — kg |
| Weight (kg) Cohort 2 | 81.48 kg STANDARD_DEVIATION 16.76 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 59 / 99 | 16 / 32 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Effectiveness Endpoint 1: Technical Success
Technical success occurs when a subject is successfully implanted with a PIVSD device in the ventricular septal defect. An implant attempt occurs when the delivery system is inserted in the subject's vasculature.
Time frame: End of Implant Procedure
Population: The analysis population includes all Emergency and Compassionate PIVSD subjects who have an attempted device placement (defined as the delivery system enters the subject's vasculature in an attempt to place a device) from 2011 until the end of 2016.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Effectiveness Endpoint 1: Technical Success | 76 Participants |
Primary
Effectiveness Endpoint 2: Acute Closure
Acute closure is defined as the absence of a residual shunt ≥3 mm, and will be assessed based on an echocardiogram obtained immediately after the successful deployment of the device and up to 7 days post-procedure.
Time frame: Up to 7 days post-procedure
Population: The analysis population will include all enrolled subjects, i.e., this population will include subjects from Cohort 2 which will be comprised of subjects who have previously been successfully implanted with the PIVSD Occluder, the subject's post-procedure echocardiogram is able to be evaluated for residual shunt by the echocardiography core laboratory, and, for living subjects, informed consent has been obtained.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Effectiveness Endpoint 2: Acute Closure | 17 Participants |
Primary
Effectiveness Endpoint 3: Chronic Closure
Chronic closure is defined as the absence of a residual shunt ≥3 mm at 6 months or later.
Time frame: 6 months or later following a PIVSD device implant through study completion, an average of 1 year
Population: The analysis population will include enrolled subjects from Cohort 2 with an implanted PIVSD device who have a 6-months or later post-procedure echocardiogram available for review.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Effectiveness Endpoint 3: Chronic Closure | 4 Participants |
Primary
Safety Endpoint 1: Acute Survival
Acute survival is defined as survival for at least 24 hours following an attempted PIVSD device implant.
Time frame: Equal to or greater than 24 hours following an attempted PIVSD device implant through study completion, up to 9.7 years post-procedure
Population: The analysis population will include all Emergency and Compassionate PIVSD subjects who have an attempted device placement from 2011 until the end of 2016 but will exclude subjects whose survival status is not known through at least 24 hours after the procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Safety Endpoint 1: Acute Survival | 75 Participants |
Primary
Safety Endpoint 2: Chronic Survival
Chronic survival is defined as survival for at least 183 days from the time of first successful implant.
Time frame: Equal to or greater than 183 days from the time of first successful implant through study completion, up to 9.7 years post-procedure
Population: The analysis will be conducted on both cohorts. The first analysis population is Cohort 1(all Emergency and Compassionate PIVSD subjects who have an attempted device placement from 2011 until the end of 2016). The second analysis population is Cohort 2 (those previously implanted with the PIVSD Occluder, provided informed consent (for living subjects only), and the subject's post-procedure echocardiogram is able to be evaluated for residual shunt by the echocardiography core laboratory).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Safety Endpoint 2: Chronic Survival | 37.2 percentage of participants |
| Cohort 2 | Safety Endpoint 2: Chronic Survival | 46.4 percentage of participants |