N/A N=20 Treatment

Observation of ImageReady™ MR Conditional Defibrillation System in China

Arrhythmia

Bottom Line

View on ClinicalTrials.gov: NCT03451721 ↗

Enrolled (actual)

Serious AEs

30.0%

Results posted

Apr 2020

Primary outcome: Primary: The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free — 100 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ImageReady™ MR Conditional Defibrillation System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boston Scientific Corporation
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free	100	—
PRIMARY The Percentage of Participant Whose the Average RV Shocking Impedance is >200 Ohm 1 Month Post Scan, While it is ≤ 200 Ohm Before Scan	—	—
PRIMARY The Percentage of Participant That Have an Increase in Average RV Pacing Thresholds > 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up	—	—
PRIMARY The Percentage of Participant That Have the Average RV Sensed Amplitude at the MRI + 1 Month Visit Remains < 5.0 mV or Less Than 50% of the Pre-MR Scan Value	—	—
PRIMARY The Percentage of Participant Have an Increase in Average LV Pacing Thresholds >1.0V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up	—	—
PRIMARY the Percentage of Participant That Have the Average LV Sensed Amplitude at the MRI + 1 Month Visit Remains <5.0 mV or Above 50% of the Pre-MR Scan Value	—	—

Summary

To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.

Eligibility Criteria

Inclusion Criteria

Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology
Subject must have the ImageReady System as their initial (de novo) defibrillation system implant
Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD
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 an approved clinical study center and at the intervals defined by this protocol
Subject is age 18 or above

Exclusion Criteria

Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders
Presence of metallic objects that represent a contraindication to MR imaging at the discretion of the Radiologist and impacting the ability to conduct the study protocol
Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit
Subject with:
A history of syncope related to brady-arrhythmia
A history of syncope of unknown etiology
Sinus pauses (Pause > 2 s)
Permanent or intermittent complete AV block
Documentation of progressive AV nodal block over time
Trifascicular block (alternating bundle branch block or PR > 200 ms with LBBB or other bifascicular block)
Note: It is required to run a 12 lead ECG and a 10s rhythm strip to document this exclusion criterion.
Subject is not clinically capable of tolerating the absence of pacing or Resynchronization therapy support in a supine position for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion
Subject is not clinically capable of tolerating the absence of Tachycardia therapy support for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion
Subjects currently requiring dialysis
Subject has a mechanical heart valve
Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
Subject is currently on the active heart transplant list
Subject has documented life expectancy of less than 12 months
Subject is enrolled in any other concurrent study that might interfere with this study
Women of childbearing potential who are or might be pregnant at the time of this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03451721). 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.