Observation of ImageReady™ MR Conditional Pacing System in China

NCT02636712 | Completed Results

• 1 other identifier: C1913
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Arhythmia; Atrioventricular Heart-block; Chronic Bundle Branch or Branch Block; Carotid Sinus Hypersensitivity Reaction Syndrome; Vasovagal Syncope

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Percentage of Participants Without System-related Complications

  Within 3 months after the Pacemaker been implanted.

Study Arms (1)

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

Device: ImageReady™ MR Conditional Pacing System

Interventions

ImageReady™ MR Conditional Pacing System DEVICE

ImageReady™ MR Conditional Pacing System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (7)

• 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.

  PMID: 21969340 BACKGROUND

• 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.

  PMID: 23453091 BACKGROUND

• BSC data on file. 91022242_SAMURAI_FDA endpoint report_29JUN2015_Final_revAC.

  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

• 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.

  PMID: 18547191 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.

  PMID: 17515363 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

  BACKGROUND

MeSH Terms

Conditions

Atrioventricular Block; Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr Yangang Su
• Organization: Zhongshan Hospital

suyangang111@163.com

+86 13788905096

Study Officials

• Yangang Su, Doctor

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

• Kejiang Cao, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 22, 2015
• Study Start: December 8, 2015
• Primary Completion: March 16, 2016
• Study Completion: November 1, 2017
• Last Updated: April 8, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)