Clinical trial NCT02636712: Observation of ImageReady™ MR Conditional Pacing System in China
Official title: Observation of ImageReady™ MR Conditional Pacing System in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arhythmia
Atrioventricular Heart-block
Chronic Bundle Branch or Branch Block
Carotid Sinus Hypersensitivity Reaction Syndrome
Vasovagal Syncope
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Without Complications at MRI Visit + 1 Month.
timeFrame: Within 1 month after the Pacemaker been implanted.
measure: 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
timeFrame: Pre-MR scan and 1 Month post-MR Scan.
measure: 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
timeFrame: Pre-MR scan and 1 Month post-MR Scan.
measure: 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.
timeFrame: Pre-MR scan and 1 Month post-MR Scan.
Secondary outcomes:
measure: Percentage of Participants Without System-related Complications
timeFrame: Within 3 months after the Pacemaker been implanted.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Yangang Su, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Kejiang Cao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: BSC data on file. 91022242_SAMURAI_FDA endpoint report_29JUN2015_Final_revAC.
citation: 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
citation: 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.
citation: 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.
citation: 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