Trial Outcomes & Findings for Observation of ImageReady™ MR Conditional Defibrillation System in China (NCT NCT03451721)
NCT ID: NCT03451721
Last Updated: 2021-11-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
MRI + 1 Month Visit（10-13 weeks from 0 day）
Results posted on
2021-11-01
Participant Flow
The recruitment was finished on 27Dec2018 and total 20 patients enrolled in study
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Observation of ImageReady™ MR Conditional Defibrillation System in China
Baseline characteristics by cohort
| Measure |
ImageReady™ MR Conditional Defibrillation System
n=20 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
60.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Han Chinese
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
20 Participants
n=5 Participants
|
|
Arrhythmia History
Atrioventricular block
|
4 Participants
n=5 Participants
|
|
Arrhythmia History
Supraventricular Tachycardia
|
1 Participants
n=5 Participants
|
|
Arrhythmia History
Atrial Fibrillation Paroxysmal
|
2 Participants
n=5 Participants
|
|
Arrhythmia History
Atrial Fibrillation Persistent
|
1 Participants
n=5 Participants
|
|
Arrhythmia History
Ventricular tachycardia / Ventricular Fibrillation
|
9 Participants
n=5 Participants
|
|
Arrhythmia History
Other
|
5 Participants
n=5 Participants
|
|
Cardiac Disease History
Hypertension
|
11 Participants
n=5 Participants
|
|
Cardiac Disease History
Diabetes
|
5 Participants
n=5 Participants
|
|
Cardiac Disease History
Renal Disease
|
2 Participants
n=5 Participants
|
|
Cardiac Disease History
Chronic Pulmonary Disease
|
2 Participants
n=5 Participants
|
|
Cardiac Disease History
Cerebrovascular Disease
|
1 Participants
n=5 Participants
|
|
Cardiac Disease History
Coronary Artery Disease (CAD)
|
11 Participants
n=5 Participants
|
|
Cardiac Disease History
Valvular Heart Disease
|
3 Participants
n=5 Participants
|
|
Cardiac Disease History
Heart Failure
|
4 Participants
n=5 Participants
|
|
Cardiac Disease History
Other
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: MRI + 1 Month Visit（10-13 weeks from 0 day）Population: 20 patients enrolled. 19 attended the MR scan.
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.
Outcome measures
| Measure |
ImageReady™ MR Conditional Defibrillation System
n=19 Participants
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
|
|---|---|
|
The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free
|
100 percentage of participants
Interval 82.4 to 100.0
|
PRIMARY outcome
Timeframe: MRI+1 Month visit ( 10~13 weeks from 0 day)Population: 20 patients enrolled. 19 attended the MR 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.
Outcome measures
| Measure |
ImageReady™ MR Conditional Defibrillation System
n=19 Participants
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
|
|---|---|
|
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
Interval 0.0 to 17.6
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
ImageReady™ MR Conditional Defibrillation System
n=19 Participants
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
|
|---|---|
|
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
Interval 0.0 to 17.6
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
ImageReady™ MR Conditional Defibrillation System
n=19 Participants
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
|
|---|---|
|
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
Interval 0.0 to 17.6
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
ImageReady™ MR Conditional Defibrillation System
n=9 Participants
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
|
|---|---|
|
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
Interval 0.0 to 33.6
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
ImageReady™ MR Conditional Defibrillation System
n=9 Participants
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
|
|---|---|
|
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
Interval 0.0 to 33.6
|
Adverse Events
ImageReady™ MR Conditional Defibrillation System
Serious events: 6 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ImageReady™ MR Conditional Defibrillation System
n=20 participants at risk
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
|
|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
5.0%
1/20 • Number of events 2 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Cardiac disorders
Cardiac arrest
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Cardiac disorders
Cardiac failure acute
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Cardiac disorders
Ventricular tachycardia
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Nervous system disorders
Cerebral infarction
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Vascular disorders
Haematoma
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
Other adverse events
| Measure |
ImageReady™ MR Conditional Defibrillation System
n=20 participants at risk
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
|
|---|---|
|
Cardiac disorders
Cardiac failure acute
|
10.0%
2/20 • Number of events 2 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Cardiac disorders
Ventricular tachycardia
|
10.0%
2/20 • Number of events 2 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Cardiac disorders
Cardiac failure
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Cardiac disorders
Cardiomyopathy
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Cardiac disorders
Left ventricular failure
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Gastrointestinal disorders
Rectal polyp
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
General disorders
Pyrexia
|
10.0%
2/20 • Number of events 2 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
General disorders
Implant site extravasation
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Renal and urinary disorders
Micturition disorder
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
10.0%
2/20 • Number of events 2 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Vascular disorders
Varicose vein
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Hepatobiliary disorders
Biliary colic
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Hepatobiliary disorders
Cholecystitis
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Investigations
Acid base balance abnormal
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic spasm
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Eye disorders
Diabetic retinopathy
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Injury, poisoning and procedural complications
Wound complication
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Product Issues
Device stimulation issue
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.0%
1/20 • Number of events 1 • Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place