Skip to main content
OpenTrials
Completed

NCT Number: NCT02636712

Observation of ImageReady™ MR Conditional Pacing System in China

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arhythmia Arrhythmias, Cardiac Atrioventricular Block Atrioventricular Heart-block Autonomic Nervous System Diseases Cardiac Conduction System Disease Cardiovascular Diseases Carotid Sinus Hypersensitivity Reaction Syndrome Chronic Bundle Branch or Branch Block Consciousness Disorders Heart Block Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Syncope Syncope, Vasovagal Unconsciousness Vasovagal Syncope

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangsu Province Hospital, Nanjing, Jiangsu, China

Loading trial locations.

About this study

Key Inclusion Criteria:

  • Subject must have the Image Ready 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 guidelines.
  • 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.

Key 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 Safety Endpoint:

MR Scan related Complication Free Rate Analyzed at MRI Visit +1 Month.

Primary efficacy Endpoint:

  • Pacing Threshold (at 0.5 ms pulse width) comparison pre and 1 Month post MR Scan: pacing threshold increase ≤ 0.5 V after scan.
  • Sensed Amplitude comparison pre- and 1 Month post-MR Scan: sensed amplitude: ≥ 1.0 mV after scan, and ≥ 50% of that before scan.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ImageReady™ MR Conditional Pacing System

Device

Primary outcomes

  1. Percentage of Participants Without Complications at MRI Visit + 1 Month.

    Time frame: Within 1 month after the Pacemaker been implanted.

    No one has any complications related MR Scan . So Complication-Free rate is 100%.

  2. 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

    Time frame: Pre-MR scan and 1 Month post-MR Scan.

    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.

  3. 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

    Time frame: Pre-MR scan and 1 Month post-MR Scan.

    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%.

  4. 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.

    Time frame: Pre-MR scan and 1 Month post-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%.

Secondary outcomes

  1. Percentage of Participants Without System-related Complications

    Time frame: Within 3 months after the Pacemaker been implanted.

    No one has any complications related system occurred. So Complication-Free rate is 100%.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 22, 2015
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.