Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To observe the safety and effectiveness of ImageReadyâ„¢ MR conditional defibrillation system in a Chinese population.
This is a multi-center, prospective, single-arm study, aimed to observe the safety and effectiveness of ImageReadyâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ImageReadyâ„¢ MR Conditional Defibrillation System | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ImageReadyâ„¢ MR Conditional Defibrillation System | Device | Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | MRI + 1 Month Visit（10-13 weeks from 0 day） |
| 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. | MRI+1 Month visit ( 10~13 weeks from 0 day) |
| 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. | MRI+1Month visit( 10~14 weeks from 0 day) |
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders
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
Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit
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)
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
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
Subjects currently requiring dialysis
Subject has a mechanical heart valve
Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
Subject is currently on the active heart transplant list
Subject has documented life expectancy of less than 12 months
Subject is enrolled in any other concurrent study that might interfere with this study
Women of childbearing potential who are or might be pregnant at the time of this study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yangang Su, Doctor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21969340 | Background | Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004. | |
| 28225684 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The recruitment was finished on 27Dec2018 and total 20 patients enrolled in study
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ImageReadyâ„¢ MR Conditional Defibrillation System |
ImageReadyâ„¢ MR Conditional Defibrillation System: Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ImageReadyâ„¢ MR Conditional Defibrillation System |
ImageReadyâ„¢ MR Conditional Defibrillation System: Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 20 patients enrolled. 19 attended the MR scan. | Posted | Number | 95% Confidence Interval | percentage of participants | MRI + 1 Month Visit（10-13 weeks from 0 day） |
|
Adverse event data were monitored at points of Enrollment, Implant, Pre-discharge, MRI Visit and MRI+1 Month visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ImageReadyâ„¢ MR Conditional Defibrillation System |
ImageReadyâ„¢ MR Conditional Defibrillation System: Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Yangang Su | Zhongshan Hospital | +86 13788905096 | suyangang111@163.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2018 | Apr 22, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MR+1 Month visit( 10~14 weeks from 0 day) |
| 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. | MR +1 Month visit( 10~14 weeks from 0 day) |
| 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. | MR +1 Month visit( 10~14 weeks from 0 day) |
| Russo RJ, Costa HS, Silva PD, Anderson JL, Arshad A, Biederman RW, Boyle NG, Frabizzio JV, Birgersdotter-Green U, Higgins SL, Lampert R, Machado CE, Martin ET, Rivard AL, Rubenstein JC, Schaerf RH, Schwartz JD, Shah DJ, Tomassoni GF, Tominaga GT, Tonkin AE, Uretsky S, Wolff SD. Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med. 2017 Feb 23;376(8):755-764. doi: 10.1056/NEJMoa1603265. |
| Background | ASTM Standard F2503-08, "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment" ASTM International, West Conshohocken, PA, 2008, DOI: 10.1520/F2503-08, www.astm.org.. |
| Background | Chinese Medical Association ECG Physiology and Pacing Branch, Chinese Medical Association Cardiology Branch, Chinese Medical Association Cardiology Professional Committee implanted cardioverter defibrillator treatment. Implanted cardioverter defibrillator treatment of China Expert consensus. Chinese Journal of Cardiac Arrhythmias 2014;18:242-53. |
| Background | Shu Zhang, Dejia Huang, Wei Hua, et al. Advice on cardiac resynchronization therapy for chronic heart failure (revised in 2013). Chinese Journal of Cardiac Arrhythmias 2013;17:247-61. |
| 18547191 | Background | Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, Clayton EW, Fletcher JG, Georgieff MK, Hammerschmidt D, Hudson K, Illes J, Kapur V, Keane MA, Koenig BA, Leroy BS, McFarland EG, Paradise J, Parker LS, Terry SF, Van Ness B, Wilfond BS. Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics. 2008 Summer;36(2):219-48, 211. doi: 10.1111/j.1748-720X.2008.00266.x. |
| 17515363 | Background | Kanal E, Barkovich AJ, Bell C, Borgstede JP, Bradley WG Jr, Froelich JW, Gilk T, Gimbel JR, Gosbee J, Kuhni-Kaminski E, Lester JW Jr, Nyenhuis J, Parag Y, Schaefer DJ, Sebek-Scoumis EA, Weinreb J, Zaremba LA, Wilcox P, Lucey L, Sass N; ACR Blue Ribbon Panel on MR Safety. ACR guidance document for safe MR practices: 2007. AJR Am J Roentgenol. 2007 Jun;188(6):1447-74. doi: 10.2214/AJR.06.1616. No abstract available. |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Arrhythmia History | Count of Participants | Participants |
|
| Cardiac Disease History | Count of Participants | Participants |
|
|
|
| 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. | 20 patients enrolled. 19 attended the MR scan. | Posted | Number | 95% Confidence Interval | percentage of participant | MRI+1 Month visit ( 10~13 weeks from 0 day) |
|
|
|
| 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. | 20 patients enrolled.19 of them underwent the MR scan and the evaluation of RV pacing thresholds | Posted | Number | 95% Confidence Interval | percentage of participant | MRI+1Month visit( 10~14 weeks from 0 day) |
|
|
|
| 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. | 20 patients enrolled.19 of them underwent the MR scan and the evaluation of RV sensed amplitude | Posted | Number | 95% Confidence Interval | percentage of participant | MR+1 Month visit( 10~14 weeks from 0 day) |
|
|
|
| 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. | only 10 patients implanted with LV leads and underwent the evaluation of LV pacing thresholds. Besides, 9 of them underwent the MR scan. | Posted | Number | 95% Confidence Interval | percentage of participant | MR +1 Month visit( 10~14 weeks from 0 day) |
|
|
|
| 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. | only 10 patients implanted with LV leads and underwent the evaluation of LV sensed amplitude. Besides, 9 of them underwent the MR scan. | Posted | Number | 95% Confidence Interval | percentage of participant | MR +1 Month visit( 10~14 weeks from 0 day) |
|
|
|
| 1 |
| 20 |
| 6 |
| 20 |
| 11 |
| 20 |
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Implant site extravasation | General disorders | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | Non-systematic Assessment |
|
| Micturition disorder | Renal and urinary disorders | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | Non-systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Acid base balance abnormal | Investigations | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | Non-systematic Assessment |
|
| Diaphragmatic spasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Carotid arteriosclerosis | Nervous system disorders | Non-systematic Assessment |
|
| Device stimulation issue | Product Issues | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment |
|
Not provided
Not provided