Observation of ImageReady™ MR Conditional Pacing System in China

Boston Scientific

Status: Completed

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

Treatments: Device: ImageReady™ MR Conditional Pacing System

Study type: Observational

Funder types: Industry

Identifiers

NCT02636712

C1913

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

ImageReady™ MR Conditional Pacing System

Description:

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

Treatment:

Device: ImageReady™ MR Conditional Pacing System