BradycardiaTendrilMRI™NCT01528150

Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication

An observational study of Bradycardia, run by Abbott Medical Devices.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bradycardia
How many people: 466 participants
Where: No sites listed yet
Study dates: Feb 2012to Mar 2015
How long will I take part?: 12 Months
Phase: Observational
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

Study population: standard bradycardia indications

Who may be able to join

Approved Class I or Class II indication per: European Society of Cardiology (ESC) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker, OR American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker
Require a new Accent MRI™ pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
Is ≥ 18 years of age.
Able to provide written informed consent prior to any investigational related procedure.
Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Who cannot join

Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment).
Have an existing active implanted medical device (e.g., Implantable Cardioverter Defibrillator (ICD), neurostimulator, etc.).
Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
Have a lead extender, plug or adaptor.
Have a prosthetic tricuspid heart valve.
Are currently participating in another investigational device or drug investigation.

Show all 9Show fewer

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 from Screening due to any life-threatening condition

About this study

Official title: Clinical Investigation to Assess the Safety and Efficacy of the Tendril MRI™ Leads, as a Part of the Accent MRI™ System, in Patients With Standard Bradycardia Pacing Indication.

Read the detailed description

Magnetic resonance imaging (MRI) is a diagnostic method to view high quality two and three dimensional images of the body. However, magnetic resonance imaging systems generate three electromagnetic fields that are used to produce an image. These include a static magnetic field, a time varying gradient magnetic field, and a radiofrequency field. All three of these fields interact with implanted devices and could create hazards for the device, the patient, or both. Due to these issues, currently marketed pacemaker systems may be contraindicated for use in an MRI environment.

St. Jude Medical has developed a system, the Accent MRI™ system, comprised of the Accent MRI™ device and the Tendril MRI™ lead, and an investigational MRI Activator™, designed to mitigate such interactions.

Conditions: Bradycardia
Medical subject headings: Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01528150
Study group	Role	What they receive
Accent MRI System		Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads

What is being measured

The primary outcome is the main question the study is designed to answer.

Freedom From RA and RV Lead-related Complications
Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.
Measured: up to 12 months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Mar 2015

First posted7 Feb 2012 (estimated)
Study startFeb 2012
Primary completionJun 2014
Study completionMar 2015

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 466 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT01528150
Sponsor's protocol ID: CR-11-054-EU-LV
Acronym: TendrilMRI™
Status last verified: Jan 2019
First submitted: 3 Feb 2012
Last updated: 4 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Bradycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation to Assess the Safety and Efficacy of the Tendril MRI™ Leads, as a Part of the Accent MRI™ System, in Patients With Standard Bradycardia Pacing Indication.
ClinicalTrials.gov ID: NCT01528150
Acronym / sponsor ID: TendrilMRI™ / CR-11-054-EU-LV
Conditions: Bradycardia
Study type: Observational
Recruitment status: Completed
Enrolment: 466 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Jun 2014 (actual)
Study completion: Mar 2015 (actual)
First posted: 7 Feb 2012 (estimated)
Results: Posted 31 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months
Number of arms: 1

Arm	Type	Receives
Accent MRI System	–	–Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: standard bradycardia indications

Key inclusion criteria (5 listed)

Approved Class I or Class II indication per: European Society of Cardiology (ESC) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker, OR American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker
Require a new Accent MRI™ pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
Is ≥ 18 years of age.
Able to provide written informed consent prior to any investigational related procedure.
Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Key exclusion criteria (9 listed)

Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment).
Have an existing active implanted medical device (e.g., Implantable Cardioverter Defibrillator (ICD), neurostimulator, etc.).
Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
Have a lead extender, plug or adaptor.
Have a prosthetic tricuspid heart valve.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Freedom From RA and RV Lead-related Complications
Time frame: up to 12 months post-implant
Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.

Results and safety

Results posted to the registry on 31 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Accent MRI System	466	422

Primary outcome: Freedom From RA and RV Lead-related Complications

Time frame: up to 12 months post-implant. Number (97.5% Confidence Interval). Unit: percentage of participants

Measure	Accent MRI System n = 463
Acute Timeframe (Implant to 2 Months)	97.19 (94.94 to 98.63)
Chronic Timeframe (>2 Months to 12 Months)	99.14 (97.58 to 99.81)

Population analysed: A total of 464 patients were implanted. 463 patients (99.78%) were implanted with Accent MRI™ systems with the Tendril MRI™ leads while the remaining 1 patient (0.22%) was implanted with a device that was not an Accent MRI™ system. This patient was excluded from all primary endpoint analyses.

Adverse events

Time frame: Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Accent MRI System	174 of 466 (37.3%)	78 of 466 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Bradycardia

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
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RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
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Active, not recruitingObservational study
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BIO|STREAM.CSP 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.

Rob RW Breedveld, MD principal investigator

Medical Center Leeuwarden, the Netherlands

Questions about this trial

What is this clinical trial studying?

An observational study of Bradycardia, run by Abbott Medical Devices.

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 5 inclusion and 9 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

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 31 Aug 2016). 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 RA and RV Lead-related Complications (time frame: up to 12 months post-implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528150.

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 4 Feb 2019.