Observation of ImageReady™ MR Conditional Pacing System in China

To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects

Study Overview

• Status: Completed
• Conditions: Vasovagal Syncope; Arhythmia; Atrioventricular Heart-block; Chronic Bundle Branch or Branch Block; Carotid Sinus Hypersensitivity Reaction Syndrome
• Intervention / Treatment: Device: ImageReady™ MR Conditional Pacing System

Detailed Description

Key Inclusion Criteria:

1. Subject must have the Image Ready 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.
3. Subject is able and willing to undergo an MR scan.•
4. 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.
5. Subject is age 18 or above.

Key Exclusion Criteria

1. Subject has or has had any pacing or ICD system implants.
2. Subject has any implants or devices that are not suitable for MR scan.
3. Subject is enrolled in any other concurrent study that might interfere with this study.
4. Subject has documented life expectancy of less than 12 months.
5. 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:

1. Pacing Threshold (at 0.5 ms pulse width) comparison pre and 1 Month post MR Scan: pacing threshold increase ≤ 0.5 V after scan.
2. Sensed Amplitude comparison pre- and 1 Month post-MR Scan: sensed amplitude: ≥ 1.0 mV after scan, and ≥ 50% of that before scan.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Shanghai Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ImageReady™ MR Conditional Pacing System; 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 guidelines	Device: ImageReady™ MR Conditional Pacing System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Without Complications at MRI Visit + 1 Month.	No one has any complications related MR Scan . So Complication-Free rate is 100%.	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.	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%.	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%.	Pre-MR scan and 1 Month post-MR Scan.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Without System-related Complications	No one has any complications related system occurred. So Complication-Free rate is 100%.	Within 3 months after the Pacemaker been implanted.

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Yangang Su, Doctor, Shanghai Zhongshan Hospital; Principal Investigator: Kejiang Cao, Doctor, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Russo 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.
• BSC 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
• 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 record dates

Study Major Dates

• Study Start (Actual): December 8, 2015
• Primary Completion (Actual): March 16, 2016
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Immune System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Hypersensitivity; Heart Block; Syncope; Syncope, Vasovagal; Atrioventricular Block
• Other Study ID Numbers: C1913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO