Observation of ImageReady™ MR Conditional Pacing System in China

Vasovagal Syncope Clinical Trial

Official title:

Observation of ImageReady™ MR Conditional Pacing System in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636712
• Other study ID #: C1913
• Status: Completed
• Start date: December 8, 2015
• Est. completion date: November 2017

Study information

• Verified date: January 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2017
• Est. primary completion date: March 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• ImageReady™ MR Conditional Pacing System

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

References & Publications (7)

??, ??, ???, ???, ???, ???, ???, ???, ???, ??: ??????????——???????(2010????). ????????? 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

BSC data on file. 91022242_SAMURAI_FDA endpoint report_29JUN2015_Final_revAC.

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. — View 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. — View 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. — View Citation

Shimizu T. [Explanation of JIS T 62570 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment]. Nihon Hoshasen Gijutsu Gakkai Zasshi. 2018;74(7):739-741. doi: 10.6009/jjrt.2018_JSRT_74.7.739. Japanese. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.