ArhythmiaNCT02636712
Observation of ImageReady™ MR Conditional Pacing System in China
An observational study of Arhythmia and Atrioventricular Heart-block, run by Boston Scientific Corporation at 2 sites in China.
Trial summary
To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arhythmia, Atrioventricular Heart-block, Chronic Bundle Branch or Branch Block
- What is being tested?
- ImageReady™ MR Conditional Pacing System
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 8 Dec 2015to Nov 2017
- Phase
- Observational
- 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
Study population: Subjects included in the MR China Study should be selected from the investigator's general patient population indicated for single or dual chamber pacemaker implantation.
Who may be able to join
- Subject must have the ImageReady System as their initial (de novo) pacing system implant
- Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines5
- 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 the intervals defined by this protocol
- Subject is age 18 or above
Who cannot join
- Subject has or has had any pacing or ICD system implants
- Subject has any implants or devices that are not suitable for MR scan
- Subject is enrolled in any other concurrent study that might interfere with this study
- Subject has documented life expectancy of less than 12 months
- Women of childbearing potential who are or might be pregnant at the time of this study
Trial locations and contacts
2 sites in 1 country.
China2 sites
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
About this study
To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects
Read the detailed description
Key Inclusion Criteria:
- Subject must have the Image Ready System as their initial (de novo) pacing system implant.
- Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines.
- 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 the intervals defined by this protocol.
- Subject is age 18 or above.
Key Exclusion Criteria
- Subject has or has had any pacing or ICD system implants.
- Subject has any implants or devices that are not suitable for MR scan.
- Subject is enrolled in any other concurrent study that might interfere with this study.
- Subject has documented life expectancy of less than 12 months.
- Women of childbearing potential who are or might be pregnant at the time of this study.
Primary Safety Endpoint:
MR Scan related Complication Free Rate Analyzed at MRI Visit +1 Month.
Primary efficacy Endpoint:
- Pacing Threshold (at 0.5 ms pulse width) comparison pre and 1 Month post MR Scan: pacing threshold increase ≤ 0.5 V after scan.
- Sensed Amplitude comparison pre- and 1 Month post-MR Scan: sensed amplitude: ≥ 1.0 mV after scan, and ≥ 50% of that before scan.
- Conditions
- Arhythmia, Atrioventricular Heart-block, Chronic Bundle Branch or Branch Block, Carotid Sinus Hypersensitivity Reaction Syndrome, Vasovagal Syncope
- Being tested
- ImageReady™ MR Conditional Pacing System
- Medical subject headings
- Atrioventricular Block, Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImageReady™ MR Conditional Pacing SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| ImageReady™ MR Conditional Pacing System | 1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant
2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines Receives: Device: ImageReady™ MR Conditional Pacing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Without Complications at MRI Visit + 1 Month.
No one has any complications related MR Scan . So Complication-Free rate is 100%.
Measured: Within 1 month after the Pacemaker been implanted.
Percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up
The percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) from Pre-MR Scan to MRI Visit + 1 Month Follow-up is 100 percent.
Measured: Pre-MR scan and 1 Month post-MR Scan.
Percentage of Participants With Atrial Sensed Amplitude at the MRI Visit + 1 Month Follow up Remains ≥ 1.0 mV and Above 50% of the Pre-MR Scan Value
The Percentage of participants with atrial sensed amplitude at the MRI Visit + 1 Month Follow up remains ≥ 1.0 mV and above 50% of the pre-MR scan value is 100%.
Measured: Pre-MR scan and 1 Month post-MR Scan.
Percentage of Participants With Ventricular Sensed Amplitudes at the MRI Visit + 1 Month Follow up Remains ≥ 5.0 mV and Above 50% of the Pre-MR Scan.
The percentage of participants with ventricular sensed amplitudes at the MRI Visit + 1 Month Follow up remains ≥ 5.0 mV and above 50% of the pre-MR scan is 100%.
Measured: Pre-MR scan and 1 Month post-MR Scan.
Secondary outcomes (1)
Percentage of Participants Without System-related Complications
No one has any complications related system occurred. So Complication-Free rate is 100%.
Measured: Within 3 months after the Pacemaker been implanted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start8 Dec 2015
- Primary completion16 Mar 2016
- Study completionNov 2017
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 ArhythmiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 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, Shanghai Zhongshan HospitalKejiang Cao, Doctor, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636712
- Sponsor's protocol ID
- C1913
- Status last verified
- Jan 2020
- First submitted
- 11 Dec 2015
- Last updated
- 8 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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. Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry. Am Heart J. 2013 Mar;165(3):266-72. doi: 10.1016/j.ahj.2012.12.004. Epub 2013 Jan 28.
PubMed 23453091BSC data on file. 91022242_SAMURAI_FDA endpoint report_29JUN2015_Final_revAC.
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
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张澍, 华伟, 黄德嘉, 王景峰, 吴立群, 杨杰孚, 曹克将, 黄从新, 王方正, 陈新: 植入性心脏起搏器治疗--目前认识和建议(2010年修订版). 中华心律失常学杂志 2010; 04:245-249. Shu Zhang, Wei Hua, Dejia Huang, Jingfeng Wang, Liqun Wu, Jiefu Wu, Kejiang Cao, Congxin Huang, Fangzheng Wang, Xin Chen: Implantable Cardiac Pacemaker therapy- Cognition and Suggestion Present ( updated version on 2010). Chinese Journal of Cardiac Arrhythmia, 2010; 04:245-249
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of ImageReady™ MR Conditional Pacing System in China
- ClinicalTrials.gov ID
- NCT02636712
- Acronym / sponsor ID
- C1913
- Conditions
- Arhythmia, Atrioventricular Heart-block, Chronic Bundle Branch or Branch Block, Carotid Sinus Hypersensitivity Reaction Syndrome, Vasovagal Syncope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 16 Mar 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 27 Jan 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 efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects
Detailed description
Key Inclusion Criteria:
- Subject must have the Image Ready System as their initial (de novo) pacing system implant.
- Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines.
- 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 the intervals defined by this protocol.
- Subject is age 18 or above.
Key Exclusion Criteria
- Subject has or has had any pacing or ICD system implants.
- Subject has any implants or devices that are not suitable for MR scan.
- Subject is enrolled in any other concurrent study that might interfere with this study.
- Subject has documented life expectancy of less than 12 months.
- Women of childbearing potential who are or might be pregnant at the time of this study.
Primary Safety Endpoint:
MR Scan related Complication Free Rate Analyzed at MRI Visit +1 Month.
Primary efficacy Endpoint:
- Pacing Threshold (at 0.5 ms pulse width) comparison pre and 1 Month post MR Scan: pacing threshold increase ≤ 0.5 V after scan.
- Sensed Amplitude comparison pre- and 1 Month post-MR Scan: sensed amplitude: ≥ 1.0 mV after scan, and ≥ 50% of that before scan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ImageReady™ MR Conditional Pacing System | – | Device: ImageReady™ MR Conditional Pacing System1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant 2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects included in the MR China Study should be selected from the investigator's general patient population indicated for single or dual chamber pacemaker implantation.
Key inclusion criteria (5 listed)
- Subject must have the ImageReady System as their initial (de novo) pacing system implant
- Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines5
- 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 the intervals defined by this protocol
- Subject is age 18 or above
Key exclusion criteria (5 listed)
- Subject has or has had any pacing or ICD system implants
- Subject has any implants or devices that are not suitable for MR scan
- Subject is enrolled in any other concurrent study that might interfere with this study
- Subject has documented life expectancy of less than 12 months
- Women of childbearing potential who are or might be pregnant at the time of this study
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 Pacing System | Device | ImageReady™ MR Conditional Pacing System |
Primary outcome
Percentage of Participants Without Complications at MRI Visit + 1 Month.
Time frame: Within 1 month after the Pacemaker been implanted.
No one has any complications related MR Scan . So Complication-Free rate is 100%.
Percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up
Time frame: Pre-MR scan and 1 Month post-MR Scan.
The percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) from Pre-MR Scan to MRI Visit + 1 Month Follow-up is 100 percent.
Percentage of Participants With Atrial Sensed Amplitude at the MRI Visit + 1 Month Follow up Remains ≥ 1.0 mV and Above 50% of the Pre-MR Scan Value
Time frame: Pre-MR scan and 1 Month post-MR Scan.
The Percentage of participants with atrial sensed amplitude at the MRI Visit + 1 Month Follow up remains ≥ 1.0 mV and above 50% of the pre-MR scan value is 100%.
Percentage of Participants With Ventricular Sensed Amplitudes at the MRI Visit + 1 Month Follow up Remains ≥ 5.0 mV and Above 50% of the Pre-MR Scan.
Time frame: Pre-MR scan and 1 Month post-MR Scan.
The percentage of participants with ventricular sensed amplitudes at the MRI Visit + 1 Month Follow up remains ≥ 5.0 mV and above 50% of the pre-MR scan is 100%.
1 secondary outcome
Percentage of Participants Without System-related Complications
Time frame: Within 3 months after the Pacemaker been implanted.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- 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 23453091Russo RJ. Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry. Am Heart J. 2013 Mar;165(3):266-72. doi: 10.1016/j.ahj.2012.12.004. Epub 2013 Jan 28.
- BackgroundBSC data on file. 91022242_SAMURAI_FDA endpoint report_29JUN2015_Final_revAC.
- 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
- 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.
- Background张澍, 华伟, 黄德嘉, 王景峰, 吴立群, 杨杰孚, 曹克将, 黄从新, 王方正, 陈新: 植入性心脏起搏器治疗--目前认识和建议(2010年修订版). 中华心律失常学杂志 2010; 04:245-249. Shu Zhang, Wei Hua, Dejia Huang, Jingfeng Wang, Liqun Wu, Jiefu Wu, Kejiang Cao, Congxin Huang, Fangzheng Wang, Xin Chen: Implantable Cardiac Pacemaker therapy- Cognition and Suggestion Present ( updated version on 2010). Chinese Journal of Cardiac Arrhythmia, 2010; 04:245-249
- Individual participant dataSharing planned: No
Related trials for Arhythmia
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
Shanghai Zhongshan Hospital
Kejiang Cao, Doctor principal investigator
The First Affiliated Hospital with Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arhythmia and Atrioventricular Heart-block, run by Boston Scientific Corporation at 2 sites 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 5 inclusion and 5 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 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 27 Jan 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?
Percentage of Participants Without Complications at MRI Visit + 1 Month. (time frame: Within 1 month after the Pacemaker been implanted.). The study lists 4 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 NCT02636712, 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 8 Apr 2020.