ArrhythmiaNCT03451721
Observation of ImageReady™ MR Conditional Defibrillation System in China
A study testing ImageReady™ MR Conditional Defibrillation System in people with Arrhythmia, run by Boston Scientific Corporation at 1 site in China.
Trial summary
To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- ImageReady™ MR Conditional Defibrillation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2018to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology
- Subject must have the ImageReady System as their initial (de novo) defibrillation system implant
- Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD
- Subject is able and willing to undergo an MR scan
- 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
- Subject is age 18 or above
Who cannot join
- 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
Show all 20Show fewer
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Observation of ImageReady™ MR Conditional Defibrillation System in China (MR ICD)
To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.
Read the 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.
- Conditions
- Arrhythmia
- Being tested
- ImageReady™ MR Conditional Defibrillation System
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImageReady™ MR Conditional Defibrillation SystemDevice
Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD
| Study group | Role | What they receive |
|---|---|---|
| ImageReady™ MR Conditional Defibrillation System | Experimental | 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 Receives: Device: ImageReady™ MR Conditional Defibrillation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: MR +1 Month visit( 10~14 weeks from 0 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start3 Apr 2018
- Primary completion12 Mar 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yangang Su, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451721
- Sponsor's protocol ID
- C2082
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2017
- Last updated
- 1 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21969340Russo 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.
PubMed 28225684ASTM 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..
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.
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.
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.
PubMed 18547191Kanal 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.
PubMed 17515363
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of ImageReady™ MR Conditional Defibrillation System in China (MR ICD)
- ClinicalTrials.gov ID
- NCT03451721
- Acronym / sponsor ID
- C2082
- Conditions
- Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ImageReady™ MR Conditional Defibrillation System | Experimental | Device: ImageReady™ MR Conditional Defibrillation System1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology
- Subject must have the ImageReady System as their initial (de novo) defibrillation system implant
- Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD
- Subject is able and willing to undergo an MR scan
- 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
Key exclusion criteria (20 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImageReady™ MR Conditional Defibrillation SystemSubject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD | Device | ImageReady™ MR Conditional Defibrillation System |
Primary outcome
The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21969340Nazarian 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.
- Background: PubMed 28225684Russo 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.
- BackgroundASTM 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..
- BackgroundChinese 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.
- BackgroundShu 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.
- Background: PubMed 18547191Wolf 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.
- Background: PubMed 17515363Kanal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yangang Su, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ImageReady™ MR Conditional Defibrillation System in people with Arrhythmia, run by Boston Scientific Corporation at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free (time frame: MRI + 1 Month Visit（10-13 weeks from 0 day）). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03451721, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.