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 range18 Years

SexALL

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

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 range18 Years

SexALL

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.