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Accent Cardiac MRI Study (Accent Cardiac)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT02041702
First received: December 20, 2013
Last updated: July 17, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Bradycardia
Procedure: Cardiac MRI scan
Device: SJM MRI conditional pacing system implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the Safety and Efficacy of SJM MRI Conditional Pacing System in Patients Undergoing Cardiac Magnetic Resonance Imaging (Conducted Under the Protocol Title "A Clinical Evaluation of the SJM MRI Conditional Pacing System in Subjects Undergoing Cardiac Magnetic Resonance Imaging " in India)

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from MRI scan-related complications [ Time Frame: MRI Visit ,1 Month Post MRI Visit ] [ Designated as safety issue: Yes ]
  • Change in right atrial/ventricular capture threshold @0.5ms before and 1 month after the MRI scan [ Time Frame: MRI Visit ,1 Month Post MRI Visit ] [ Designated as safety issue: No ]
  • Change in right atrial/ventricular sensing amplitude before and 1 month after the MRI scan [ Time Frame: MRI Visit, 1 Month Post MRI Visit ] [ Designated as safety issue: No ]

Enrollment: 283
Study Start Date: June 2014
Study Completion Date: May 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardiac MRI Scan
Patients receiving the SJM MRI conditional pacing system implant who are randomized into the experimental group will undergo a Cardiac MRI scan .
Procedure: Cardiac MRI scan
Patients who are randomized into the Cardiac MRI Scan group will undergo a Cardiac MRI scan
Other Names:
  • Magnetic
  • Cardiac
  • Chest
  • Cardiovascular
Device: SJM MRI conditional pacing system implant
Patients in both arms of this study should receive SJM MRI conditional pacing system implant before randomization
Other Names:
  • Accent MRI Pacemaker
  • Tendril MRI lead
Active Comparator: MRI Control
Patients receiving the SJM MRI conditional pacing system implant who are randomized into this group will not undergo Cardiac MRI group
Device: SJM MRI conditional pacing system implant
Patients in both arms of this study should receive SJM MRI conditional pacing system implant before randomization
Other Names:
  • Accent MRI Pacemaker
  • Tendril MRI lead

Detailed Description:

The purpose of this study is to evaluate the safety and efficacy of SJM MRI conditional pacing system during and after Cardiac Magnetic Resonance Imaging (MRI) Scan. The SJM MRI conditional pacing system consists of a SJM MRI conditional pacemaker and leads. It is conditionally safe for use in the MRI environment.The study will be conducted in Asian regions/countries.

Accent Cardiac MRI study is a prospective,randomized ,multi center study .After signing the consent form ,patients will be enrolled in this study. Total subjects number will be 252 .These patients will be randomized into 2 groups: 126 patients will be randomized into the MRI scan group and 126 patients will be randomized into the control group. The study will last 2.5 years .Individual patient participation in the study will last approximately 4 to 5 months.

All patients who decide to participate in the study will be implanted with the Accent MRI ™ dual chamber pacemaker and Tendril MRI™ leads or other commercially available new SJM MRI conditional pacing system. After implant, before the MRI visit, patients will be randomized to either MRI Scan Group or Control Group in a 1:1 ratio. Patients in MRI Scan Group will undergo an MRI scan at the MRI visit (9~12 weeks after implant) while patients in Control Group will not receive an MRI scan in that visit. After MRI scan ,the patient's pacing system will be examined with a programmer to assess whether there are any changes in electronic parameters such as pacing capture threshold,sensing amplitude as well as lead impedence . 1 month after the MRI visit , all patients will come back to hospital to have another study follow up including physical examination and device interrogation .

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041702

Locations
China
Zhejiang Greentown Cardiovascular Disease Hospital
Hangzhou, China
Prince of Wales Hospital
Hong Kong, China
India
Fortis Hospital
Mohali, Punjab, India
Care Institute of Medical Sciences
Ahmedabad, India
Apollo Hospitals, Bhubaneshwar
Bhubaneshwar, India
Medanta - The Medicity Hospital
Gurgaon, India
All India Institute of Medical Sciences, New Delhi
New Delhi, India
Escorts Heart Institute and Research Centre
New Delhi, India
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, India
Max Super Specialty Hospital
New Delhi, India
Malaysia
Hospital Serdang
Kajang, Malaysia
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Chi Keong Ching, Dr National Heart Center Singapore
Principal Investigator: Rabindra Nath Chakraborty, Dr Apollo Gleneagles Hospital Kolkata India
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02041702     History of Changes
Other Study ID Numbers: CR-13-031-AP-LV 
Study First Received: December 20, 2013
Last Updated: July 17, 2016
Health Authority: Singapore: Institutional Review Board
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
India: Institutional Review Board
Malaysia: Institutional Review Board
Thailand: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by St. Jude Medical:
Bradycardia
Pacemaker
Magnetic
Conditional
St Jude
Accent
Tendril

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on December 07, 2016