BradycardiaAccent CardiacNCT02041702
Accent Cardiac MRI Study
A study testing Non-Diagnostic Cardiac MRI scan in people with Bradycardia, run by Abbott Medical Devices at 13 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Non-Diagnostic Cardiac MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 9 Jun 2014to 17 Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
- Subjects with exclusion criteria required by local law (e.g. age)
- Are unable to comply with the follow up schedule
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
India7 sites
Care Institute of Medical Sciences
Ahmedabad
Apollo Hospitals, Bhubaneshwar
Bhubaneswar
Medanta - The Medicity Hospital
Gūrgaon
Fortis Hospital
Mohali, Punjab
All India Institute of Medical Sciences, New Delhi
New Delhi
Fortis Escorts Heart Institute and Research Center
New Delhi
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi
Thailand3 sites
King Chulalongkorn Memorial Hospital
Bangkok
Ramathibodi Hospital
Bangkok
Siriraj Hospital
Bangkok
About this study
Official title: A Clinical Evaluation of the Safety and Efficacy of St. Jude Medical (SJM) Magnetic Resonance Imaging (MRI) Conditional Pacing System in Patients Undergoing Cardiac MRI
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.
Read the detailed description
Accent Cardiac MRI study was a prospective, randomized ,multi-center study conducted in Asia. Subjects indicated for dual-chamber pacemaker and who signed study consent form were considered enrolled and post implant were randomized to either Cardiac MRI Scan Group or Control Group.
Clinical evaluation and device interrogation were performed at baseline, pre- and post-MRI scan, and one month post-MRI for all subjects. At 9-12 weeks post-implant, patients in Cardiac MRI Scan Group underwent an elective non-diagnostic cardiac MRI scan at 1.5 Tesla (T) while patients in Control group underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI-related complications while efficacy endpoint was change in right atrial/ ventricular (RA/RV) capture threshold and sensing amplitude from pre-MRI scan to one month post-MRI scan.
- Conditions
- Bradycardia
- Being tested
- Non-Diagnostic Cardiac MRI scan
- Keywords
- Bradycardia, MRI Conditional Pacemaker, St Jude Medical, Accent MRI Pacemaker, Tendril MRI Lead
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Diagnostic Cardiac MRI scanDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Cardiac MRI Scan Group | Experimental | Not described Receives: Diagnostic Test: Non-Diagnostic Cardiac MRI scan |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From MRI Scan-related Complications
Number of subjects who were free from MRI scan-related complications
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: MRI Visit, 1 Month Post MRI Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study start9 Jun 2014
- Primary completion17 Mar 2016
- Study completion17 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chi Keong Ching, Dr, Principal investigator, National Heart Center SingaporeRabindra Nath Chakraborty, Dr, Principal investigator, Apollo Gleneagles Hospital Kolkata India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041702
- Sponsor's protocol ID
- CR-13-031-AP-LV
- Acronym
- Accent Cardiac
- Status last verified
- Aug 2019
- First submitted
- 20 Dec 2013
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Safety and Efficacy of St. Jude Medical (SJM) Magnetic Resonance Imaging (MRI) Conditional Pacing System in Patients Undergoing Cardiac MRI
- ClinicalTrials.gov ID
- NCT02041702
- Acronym / sponsor ID
- Accent Cardiac / CR-13-031-AP-LV
- Conditions
- Bradycardia
- Keywords
- Bradycardia, MRI Conditional Pacemaker, St Jude Medical, Accent MRI Pacemaker, Tendril MRI Lead
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2014 (actual)
- Primary completion
- 17 Mar 2016 (actual)
- Study completion
- 17 Mar 2016 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Posted 21 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Accent Cardiac MRI study was a prospective, randomized ,multi-center study conducted in Asia. Subjects indicated for dual-chamber pacemaker and who signed study consent form were considered enrolled and post implant were randomized to either Cardiac MRI Scan Group or Control Group.
Clinical evaluation and device interrogation were performed at baseline, pre- and post-MRI scan, and one month post-MRI for all subjects. At 9-12 weeks post-implant, patients in Cardiac MRI Scan Group underwent an elective non-diagnostic cardiac MRI scan at 1.5 Tesla (T) while patients in Control group underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI-related complications while efficacy endpoint was change in right atrial/ ventricular (RA/RV) capture threshold and sensing amplitude from pre-MRI scan to one month post-MRI scan.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Cardiac MRI Scan Group | Experimental | Diagnostic Test: Non-Diagnostic Cardiac MRI scan |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Diagnostic Cardiac MRI scan | Diagnostic test | Cardiac MRI Scan Group |
Primary outcome
Freedom From MRI Scan-related Complications
Time frame: MRI Visit ,1 Month Post MRI Visit
Number of subjects who were free from MRI scan-related complications
Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan
Time frame: MRI Visit ,1 Month Post MRI Visit
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
Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan
Time frame: MRI Visit, 1 Month Post MRI Visit
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
Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Time frame: MRI Visit, 1 Month Post MRI Visit
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
Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
Time frame: MRI Visit, 1 Month Post MRI Visit
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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SPIKE FLOW Endocardial Lead Safety and Performance Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Keong Ching, Dr principal investigator
National Heart Center Singapore
Rabindra Nath Chakraborty, Dr principal investigator
Apollo Gleneagles Hospital Kolkata India
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Diagnostic Cardiac MRI scan in people with Bradycardia, run by Abbott Medical Devices at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in India, Thailand, China, Hong Kong, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From MRI Scan-related Complications (time frame: MRI Visit ,1 Month Post MRI Visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.