CompletedNot Applicable

Observation of ImageReady™ MR Conditional Pacing System in China

China10 participantsStarted 2015-12-08

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Within 1 month after the Pacemaker been implanted.

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.

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.

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.

Trial details

NCT IDNCT02636712

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-03-16

Results submitted2017-03-14

View on ClinicalTrials.gov More Arhythmia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Within 1 month after the Pacemaker been implanted.

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.

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.

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.