Accent Cardiac MRI Study

NCT02041702 | Completed Results FDA Device

• 1 other identifier: CR-13-031-AP-LV
• Study Type: interventional
• Target: 283
• Locations: 5 countries
• Sites: 13

Brief Summary

The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system. The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.

Conditions

Bradycardia

Keywords

Bradycardia; MRI Conditional Pacemaker; St Jude Medical; Accent MRI Pacemaker; Tendril MRI Lead

Outcome Measures

Primary Outcomes (5)

• Freedom From MRI Scan-related Complications

  Number of subjects who were free from MRI scan-related complications

  MRI Visit ,1 Month Post MRI Visit

• Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan

  Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit

  MRI Visit ,1 Month Post MRI Visit

• Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan

  Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit

  MRI Visit, 1 Month Post MRI Visit

• Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan

  Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit

  MRI Visit, 1 Month Post MRI Visit

• Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan

  Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit

  MRI Visit, 1 Month Post MRI Visit

Study Arms (2)

Cardiac MRI Scan Group

EXPERIMENTAL

Diagnostic Test: Non-Diagnostic Cardiac MRI scan

Control Group

NO INTERVENTION

Interventions

Non-Diagnostic Cardiac MRI scan DIAGNOSTIC_TEST

Cardiac MRI Scan Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have an approved indication per American College of Cardiology(ACC)/ American Heart Association(AHA)/ Heart Rhythm Society(HRS)/ European Society of Cardiology(ESC) guidelines for implantation of a pacemaker
• Will receive a new dual chamber pacemaker and leads
• Be willing to undergo an elective 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
• Subjects must be able to undergo pectoral implantation

You may not qualify if:

• Having an existing pacemaker or Implantable Cardioverter 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
• Are unable to comply with the follow up schedule

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (13)

Zhejiang Greentown Cardiovascular Disease Hospital

Hangzhou, China

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Fortis Hospital

Mohali, Punjab, India

Location

Care Institute of Medical Sciences

Ahmedabad, India

Location

Apollo Hospitals, Bhubaneshwar

Bhubaneshwar, India

Location

Medanta - The Medicity Hospital

Gūrgaon, India

Location

All India Institute of Medical Sciences, New Delhi

New Delhi, India

Location

Fortis Escorts Heart Institute and Research Center

New Delhi, India

Location

Fortis Flt. Lt. Rajan Dhall Hospital

New Delhi, India

Location

Serdang Hospital

Kajang, Malaysia

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Project Leader Asia
• Organization: Abbott (formerly St. Jude Medical)

lyim@sjm.com

0085229967605

Study Officials

• Chi Keong Ching, Dr

  National Heart Center Singapore

  PRINCIPAL INVESTIGATOR

• Rabindra Nath Chakraborty, Dr

  Apollo Gleneagles Hospital Kolkata India

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: January 22, 2014
• Study Start: June 9, 2014
• Primary Completion: March 17, 2016
• Study Completion: March 17, 2016
• Last Updated: August 21, 2019
• Results First Posted: August 21, 2019

Record last verified: 2019-08

Locations

CN (1); IN (7); HK (1); MY (1); TH (3)