N/A
N=10
Observation of ImageReady™ MR Conditional Pacing System in China
Arhythmia · Atrioventricular Heart-block · Chronic Bundle Branch or Branch Block · Carotid Sinus Hypersensitivity Reaction Syndrome · Vasovagal Syncope
Bottom Line
View on ClinicalTrials.gov: NCT02636712 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Jan 2020
Primary outcome: Primary: Percentage of Participants Without Complications at MRI Visit + 1 Month. — 100 percentage of paticipants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ImageReady™ MR Conditional Pacing System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Without Complications at MRI Visit + 1 Month. |
100 | — |
| PRIMARY 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 |
100 | — |
| PRIMARY 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 |
100 | — |
| PRIMARY 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. |
100 | — |
| SECONDARY Percentage of Participants Without System-related Complications |
100 | — |
Summary
To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02636712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.