Arrhythmia
Conditions
Brief summary
To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.
Detailed description
This is a multi-center, prospective, single-arm study, aimed to observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.It will enroll 20 subjects in 5 sites in China.The primary safety endpoint is MR scan-related Complication-free rate between the MR Scan and the MRI + 1 Month Visit. The primary effectiveness endpoints include:1.Abnormal increase in RV shocking impedance from the pre-MR scan to the 1 Month post-MR scan. 2.Increase in RV pacing threshold from the pre-MR scan to the 1 Month post-MR scan. 3.Decrease in RV sensed amplitude from the pre-MR scan to the 1 Month post-MR scan. 4.Increase in LV pacing threshold from the pre-MR scan to the 1 Month post-MR scan. 5.Decrease in LV sensed amplitude from the pre-MR scan to the 1 Month post- MR scan.
Interventions
DEVICEImageReady™ MR Conditional Defibrillation System
Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology 2. Subject must have the ImageReady System as their initial (de novo) defibrillation system implant 3. Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD 4. Subject is able and willing to undergo an MR scan 5. Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol 6. Subject is age 18 or above
Exclusion criteria
1. Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders 2. Presence of metallic objects that represent a contraindication to MR imaging at the discretion of the Radiologist and impacting the ability to conduct the study protocol 3. Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit 4. Subject with: * A history of syncope related to brady-arrhythmia * A history of syncope of unknown etiology * Sinus pauses (Pause \> 2 s) * Permanent or intermittent complete AV block * Documentation of progressive AV nodal block over time * Trifascicular block (alternating bundle branch block or PR \> 200 ms with LBBB or other bifascicular block) * Note: It is required to run a 12 lead ECG and a 10s rhythm strip to document this exclusion criterion. 5. Subject is not clinically capable of tolerating the absence of pacing or Resynchronization therapy support in a supine position for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion 6. Subject is not clinically capable of tolerating the absence of Tachycardia therapy support for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion 7. Subjects currently requiring dialysis 8. Subject has a mechanical heart valve 9. Subject has a known or suspected sensitivity to dexamethasone acetate (DXA) 10. Subject is currently on the active heart transplant list 11. Subject has documented life expectancy of less than 12 months 12. Subject is enrolled in any other concurrent study that might interfere with this study 13. Women of childbearing potential who are or might be pregnant at the time of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free | MRI + 1 Month Visit（10-13 weeks from 0 day） | The primary safety endpoint of the MR ICD study will be assessed for all subjects who undergo any portion of the study-required MR scan sequences. Safety will be confirmed by evaluating the MR scan related ImageReady System complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month.MR scan related ImageReady System complication is relation with ImageReady System and MR Scan. |
| The Percentage of Participant Whose the Average RV Shocking Impedance is >200 Ohm 1 Month Post Scan, While it is ≤ 200 Ohm Before Scan | MRI+1 Month visit ( 10~13 weeks from 0 day) | The normal RV shocking impedance measured by the system should be≤200 Ohm, with \>200 Ohm considered abnormal. The primary effectiveness endpoint 1 is defined as that the average RV shocking impedance is \>200 Ohm at 1 month post scan, while it is ≤ 200 Ohm before scan.There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 1 occur. |
| The Percentage of Participant That Have an Increase in Average RV Pacing Thresholds > 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up | MRI+1Month visit( 10~14 weeks from 0 day) | Subjects that have an increase in average RV pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a primary effectiveness endpoint 2 event.The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 2 occur. |
| The Percentage of Participant That Have the Average RV Sensed Amplitude at the MRI + 1 Month Visit Remains < 5.0 mV or Less Than 50% of the Pre-MR Scan Value | MR+1 Month visit( 10~14 weeks from 0 day) | Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary effectiveness endpoint 3 event.The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 3 occur. |
| The Percentage of Participant Have an Increase in Average LV Pacing Thresholds >1.0V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up | MR +1 Month visit( 10~14 weeks from 0 day) | Subjects that have an increase in average LV pacing thresholds ≤1.0V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a primary effectiveness endpoint 4 event.The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 4 occur. |
| the Percentage of Participant That Have the Average LV Sensed Amplitude at the MRI + 1 Month Visit Remains <5.0 mV or Above 50% of the Pre-MR Scan Value | MR +1 Month visit( 10~14 weeks from 0 day) | Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary effectiveness endpoint 5 event.The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 5 occur. |
Countries
China
Participant flow
Recruitment details
The recruitment was finished on 27Dec2018 and total 20 patients enrolled in study
Participants by arm
| Arm | Count |
|---|---|
| ImageReady™ MR Conditional Defibrillation System 1. Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology
2. Subject must have the ImageReady System as their initial (de novo) defibrillation system implant
ImageReady™ MR Conditional Defibrillation System: Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | ImageReady™ MR Conditional Defibrillation System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 60.1 years |
| Arrhythmia History Atrial Fibrillation Paroxysmal | 2 Participants |
| Arrhythmia History Atrial Fibrillation Persistent | 1 Participants |
| Arrhythmia History Atrioventricular block | 4 Participants |
| Arrhythmia History Other | 5 Participants |
| Arrhythmia History Supraventricular Tachycardia | 1 Participants |
| Arrhythmia History Ventricular tachycardia / Ventricular Fibrillation | 9 Participants |
| Cardiac Disease History Cerebrovascular Disease | 1 Participants |
| Cardiac Disease History Chronic Pulmonary Disease | 2 Participants |
| Cardiac Disease History Coronary Artery Disease (CAD) | 11 Participants |
| Cardiac Disease History Diabetes | 5 Participants |
| Cardiac Disease History Heart Failure | 4 Participants |
| Cardiac Disease History Hypertension | 11 Participants |
| Cardiac Disease History Other | 11 Participants |
| Cardiac Disease History Renal Disease | 2 Participants |
| Cardiac Disease History Valvular Heart Disease | 3 Participants |
| Race/Ethnicity, Customized Han Chinese | 20 Participants |
| Region of Enrollment China | 20 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 20 |
| other Total, other adverse events | 11 / 20 |
| serious Total, serious adverse events | 6 / 20 |
Outcome results
Primary
The Percentage of Participant Have an Increase in Average LV Pacing Thresholds >1.0V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up
Subjects that have an increase in average LV pacing thresholds ≤1.0V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a primary effectiveness endpoint 4 event.The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 4 occur.
Time frame: MR +1 Month visit( 10~14 weeks from 0 day)
Population: only 10 patients implanted with LV leads and underwent the evaluation of LV pacing thresholds. Besides, 9 of them underwent the MR scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR Conditional Defibrillation System | The Percentage of Participant Have an Increase in Average LV Pacing Thresholds >1.0V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up | 0 percentage of participant |
Primary
The Percentage of Participant That Have an Increase in Average RV Pacing Thresholds > 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up
Subjects that have an increase in average RV pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a primary effectiveness endpoint 2 event.The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 2 occur.
Time frame: MRI+1Month visit( 10~14 weeks from 0 day)
Population: 20 patients enrolled.19 of them underwent the MR scan and the evaluation of RV pacing thresholds
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR Conditional Defibrillation System | The Percentage of Participant That Have an Increase in Average RV Pacing Thresholds > 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up | 0 percentage of participant |
Primary
the Percentage of Participant That Have the Average LV Sensed Amplitude at the MRI + 1 Month Visit Remains <5.0 mV or Above 50% of the Pre-MR Scan Value
Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary effectiveness endpoint 5 event.The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 5 occur.
Time frame: MR +1 Month visit( 10~14 weeks from 0 day)
Population: only 10 patients implanted with LV leads and underwent the evaluation of LV sensed amplitude. Besides, 9 of them underwent the MR scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR Conditional Defibrillation System | the Percentage of Participant That Have the Average LV Sensed Amplitude at the MRI + 1 Month Visit Remains <5.0 mV or Above 50% of the Pre-MR Scan Value | 0 percentage of participant |
Primary
The Percentage of Participant That Have the Average RV Sensed Amplitude at the MRI + 1 Month Visit Remains < 5.0 mV or Less Than 50% of the Pre-MR Scan Value
Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary effectiveness endpoint 3 event.The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 3 occur.
Time frame: MR+1 Month visit( 10~14 weeks from 0 day)
Population: 20 patients enrolled.19 of them underwent the MR scan and the evaluation of RV sensed amplitude
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR Conditional Defibrillation System | The Percentage of Participant That Have the Average RV Sensed Amplitude at the MRI + 1 Month Visit Remains < 5.0 mV or Less Than 50% of the Pre-MR Scan Value | 0 percentage of participant |
Primary
The Percentage of Participant Whose the Average RV Shocking Impedance is >200 Ohm 1 Month Post Scan, While it is ≤ 200 Ohm Before Scan
The normal RV shocking impedance measured by the system should be≤200 Ohm, with \>200 Ohm considered abnormal. The primary effectiveness endpoint 1 is defined as that the average RV shocking impedance is \>200 Ohm at 1 month post scan, while it is ≤ 200 Ohm before scan.There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 1 occur.
Time frame: MRI+1 Month visit ( 10~13 weeks from 0 day)
Population: 20 patients enrolled. 19 attended the MR scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR Conditional Defibrillation System | The Percentage of Participant Whose the Average RV Shocking Impedance is >200 Ohm 1 Month Post Scan, While it is ≤ 200 Ohm Before Scan | 0 percentage of participant |
Primary
The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free
The primary safety endpoint of the MR ICD study will be assessed for all subjects who undergo any portion of the study-required MR scan sequences. Safety will be confirmed by evaluating the MR scan related ImageReady System complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month.MR scan related ImageReady System complication is relation with ImageReady System and MR Scan.
Time frame: MRI + 1 Month Visit（10-13 weeks from 0 day）
Population: 20 patients enrolled. 19 attended the MR scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady™ MR Conditional Defibrillation System | The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free | 100 percentage of participants |