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Bradycardia | Accent Cardiac MRI Study

Bradycardia research study

What is the primary objective of this study?

The aim of this study is to assess the safety and efficacy of the SJM MRI conditional pacing system in subjects undergoing Cardiac Magnetic Resonance Imaging.The study hypothesis is that cardiac MRI scan will not affect the performance of the SJM MRI conditional pacing system when special conditions are met. Comparing with the control group,freedom from MRI scan-related complications and the electronic performances such as pacing threshold,sensing amplitude should be similar.

Who is eligible to participate?

Inclusion Criteria: Approved indication per ACC/AHA/HRS/ESC guidelines for implantation of an endocardial pacing system. Will receive a new dual chamber pacemaker and leads. Be willing to undergo an elective cardiac MRI scan without complete sedation, that is, under consciousness during MRI scan. Be able to provide informed consent for study participation. Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations. Is not contraindicated for an MRI scan (per the pre-MRI safety screening form). Age≥18 years. Be able to undergo pectoral implantation Exclusion Criteria: Having an existing pacemaker or Implantable Cardiac Defibrillator (ICD) A new pacemaker and lead is required for enrollment. Permanent atrial fibrillation/flutter. Are medically indicated for an MRI scan at the time of enrollment. Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc. Have a non-MRI compatible device or material implanted. Have a lead extender or adaptor. Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore. Are currently participating in a clinical investigation that includes an active treatment arm. Are allergic to dexamethasone sodium phosphate(DSP). Are pregnant or planning to become pregnant during the duration of the study. Have a life expectancy of less than 12 months due to any condition according to the investigator. Subjects with exclusion criteria required by local law (e.g.age). Are unable to comply with the follow up schedule.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bradycardia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Cardiac MRI scanPatients who are randomized into the Cardiac MRI Scan group will undergo a Cardiac MRI scan

Device:SJM MRI conditional pacing system implantPatients in both arms of this study should receive SJM MRI conditional pacing system implant before randomization

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Cardiac MRI ScanPatients receiving the SJM MRI conditional pacing system implant who are randomized into the experimental group will undergo a Cardiac MRI scan .

MRI ControlPatients receiving the SJM MRI conditional pacing system implant who are randomized into this group will not undergo Cardiac MRI group

Study Status

Completed

Start Date: June 2014

Completed Date: May 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Freedom from MRI scan-related complications

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Chi Keong Ching, Dr

Lead Sponsor: St. Jude Medical

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02041702

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