Observation of ImageReady™ MR Conditional Pacing System in China

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-08

Study Completion Date

2017-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

ImageReady™ MR Conditional Pacing System

Intervention Type DEVICE

Interventions

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ImageReady™ MR Conditional Pacing System

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No