Safety of the ProMRI Pacemaker System Under Specific MRI ConditionsNCT01761162

ProMRI Study of the Entovis Pacemaker System

An observational study of Safety of the ProMRI Pacemaker System Under Specific MRI Conditions, run by Biotronik, Inc. at 25 sites in United States.

Completed

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

Official record

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Trial summary

The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
What is being tested?: Patients with a ProMRI Pacemaker System and Magnetic Resonance Imaging (MRI) scan
Type of treatment: Medical device
How many people: 229 participants
Where: 25 sitesUnited States
Study dates: Feb 2013to May 2014
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: The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

Who may be able to join

The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:
Age greater than 18 years
Subject body height greater than 140 cm (4' 7")
Able and willing to complete MRI testing
Able to provide written informed consent
Available for follow-up visit at the study site

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Implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s). (No leads other than Setrox S (53 or 60 cm) leads may be implanted. This includes lead extensions or abandoned leads in the subject.)
Pacemaker implanted pectorally
All pacemaker system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
Underling rhythm identifiable during sensing test
All pacing thresholds are measureable and are less than or equal to 2.0 V @0.4 ms
Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
Pacing impedance is between 200 and 1500 ohm
Able and willing to use the Cardio Messenger
At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:
Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
|pacing threshold at Pre-MRI follow-up - pacing threshold at baseline| ≤ 0.5 V
All pacing thresholds are measureable and are ≤ 2.0 V @ 0.4 ms
The pacemaker system has been implanted for at least 6 weeks.
Subject did not have a pacemaker or lead explant, exchange or reposition in the previous 6 weeks.
All lead impedances are between 200 and 1500 ohm.
Battery status is at least 30% of capacity

Who cannot join

Enrolled in any other clinical study
For pacemaker systems that include an atrial lead, subjects with either
Persistent atrial arrhythmia (lasting longer than 7 days or requiring cardioversion)
Permanent atrial arrhythmia
Life expectancy of less than three months
Pregnancy

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Cardiac surgery expected in the next three months
Implanted with other medical devices that may interact with MRI, such as:
abandoned pacemaker/ICD leads
lead extensions
mechanical valves
other active medical devices
non-MRI compatible devices
other metallic artifacts/components in body that may interact with MRI

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Study site
Burlington, Massachusetts, 01805
Study site
Camden, New Jersey, 08103
John Muir Medical Center
Concord, California, 94520
Study site
Cumberland, Maryland, 21502
New York Hospital Queens
Flushing, New York, 11355
Study site
Greenville, South Carolina, 29601
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Research Medical Center
Kansas City, Missouri, 64132
Louisiana Heart Rhythm Specialists
Lafayette, Louisiana, 70503
Saint Mary Medical Center
Langhorne, Pennsylvania, 19047
Yale - New Haven Hospital
New Haven, Connecticut, 06510
Study site
New York, New York, 10016
Hoag Hospital
Newport Beach, California, 92663
Rhode Island Hospital
Providence, Rhode Island, 02903
Eisenhower Medical Center
Rancho Mirage, California, 92270
Study site
Richmond, Virginia, 23230
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85251
Washington University
St Louis, Missouri, 63110
Toledo Hospital
Toledo, Ohio, 46306
Study site
Valparaiso, Indiana, 46383
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Study site
Winston-Salem, North Carolina, 27157
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Saint Joseph Mercy Medical Center
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.

Conditions: Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Being tested: Patients with a ProMRI Pacemaker System, Magnetic Resonance Imaging (MRI) scan

What participants receive

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

Patients with a ProMRI Pacemaker SystemDevice
Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scanOther
MRI scan of head and lower back.

Study groups in NCT01761162
Study group	Role	What they receive
Pacemaker Therapy		Patients with a ProMRI Pacemaker System Receives: Device: Patients with a ProMRI Pacemaker System; Other: Magnetic Resonance Imaging (MRI) scan

What is being measured

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

MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate
Measured: 1 Month Post-MRI
Percentage of Participants Free of Atrial Pacing Threshold Rise
Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.
Measured: Pre-MRI, 1 Month Post-MRI
Percentage of Participants Free of Ventricular Pacing Threshold Rise
Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Measured: Pre-MRI, 1 Month Post-MRI
Percentage of Participants Free of P-wave Sensing Attenuation
Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Measured: Pre-MRI, 1 Month Post-MRI
Percentage of Participants Free of R-wave Sensing Attenuation
Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Measured: Pre-MRI, 1 Month Post-MRI

Timeline

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

Feb 2013May 2014

First posted4 Jan 2013 (estimated)
Study startFeb 2013
Primary completionMar 2014
Study completionMay 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Safety of the ProMRI Pacemaker System Under Specific MRI ConditionsStudies of the same condition, open and under way.
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: Case only
Time perspective: Prospective
Enrolment: 229 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01761162
Sponsor's protocol ID: G120226
Status last verified: Dec 2016
First submitted: 2 Jan 2013
Last updated: 9 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Bailey WM, Rosenthal L, Fananapazir L, Gleva M, Mazur A, Rinaldi CA, Kypta A, Merkely B, Woodard PK; ProMRI/ProMRI AFFIRM Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Jun;12(6):1183-91. doi: 10.1016/j.hrthm.2015.02.010. Epub 2015 Feb 11.
PubMed 25680307

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ProMRI Study of the Entovis Pacemaker System
ClinicalTrials.gov ID: NCT01761162
Acronym / sponsor ID: G120226
Conditions: Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Study type: Observational
Recruitment status: Completed
Enrolment: 229 participants (actual)
Lead sponsor: Biotronik, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Mar 2014 (actual)
Study completion: May 2014 (actual)
First posted: 4 Jan 2013 (estimated)
Results: Posted 4 Nov 2014

Clinical summary

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

The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pacemaker Therapy	–	Device: Patients with a ProMRI Pacemaker System, Other: Magnetic Resonance Imaging (MRI) scanPatients with a ProMRI Pacemaker System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

Key inclusion criteria (22 listed)

The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:
Age greater than 18 years
Subject body height greater than 140 cm (4' 7")
Able and willing to complete MRI testing
Able to provide written informed consent

Key exclusion criteria (14 listed)

Enrolled in any other clinical study
For pacemaker systems that include an atrial lead, subjects with either
Life expectancy of less than three months
Pregnancy
Cardiac surgery expected in the next three months

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
Patients with a ProMRI Pacemaker SystemBradycardia Slow Heart Beat	Device	Pacemaker Therapy
Magnetic Resonance Imaging (MRI) scanMRI scan of head and lower back.	Other	Pacemaker Therapy

Primary outcome

MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate
Time frame: 1 Month Post-MRI
Percentage of Participants Free of Atrial Pacing Threshold Rise
Time frame: Pre-MRI, 1 Month Post-MRI
Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of Ventricular Pacing Threshold Rise
Time frame: Pre-MRI, 1 Month Post-MRI
Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of P-wave Sensing Attenuation
Time frame: Pre-MRI, 1 Month Post-MRI
Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of R-wave Sensing Attenuation
Time frame: Pre-MRI, 1 Month Post-MRI
Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.

Results and safety

Results posted to the registry on 4 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pacemaker Therapy	229	226

Primary outcome: MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate

Time frame: 1 Month Post-MRI. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pacemaker Therapy n = 229
Value	100 (98.4 to 100)

Primary outcome: Percentage of Participants Free of Atrial Pacing Threshold Rise

Time frame: Pre-MRI, 1 Month Post-MRI. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pacemaker Therapy n = 191
Value	99.0 (96.3 to 99.9)

Population analysed: Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.

Primary outcome: Percentage of Participants Free of Ventricular Pacing Threshold Rise

Time frame: Pre-MRI, 1 Month Post-MRI. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pacemaker Therapy n = 217
Value	100 (98.3 to 100)

Population analysed: Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.

Primary outcome: Percentage of Participants Free of P-wave Sensing Attenuation

Time frame: Pre-MRI, 1 Month Post-MRI. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pacemaker Therapy n = 168
Value	99.4 (96.7 to 100)

Population analysed: Number of participants with an atrial lead and same atrial sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pacemaker Therapy	21 of 229 (9.2%)	30 of 229 (13.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25680307Bailey WM, Rosenthal L, Fananapazir L, Gleva M, Mazur A, Rinaldi CA, Kypta A, Merkely B, Woodard PK; ProMRI/ProMRI AFFIRM Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Jun;12(6):1183-91. doi: 10.1016/j.hrthm.2015.02.010. Epub 2015 Feb 11.

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.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Safety of the ProMRI Pacemaker System Under Specific MRI Conditions, run by Biotronik, Inc. at 25 sites in United States.

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 22 inclusion and 14 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. 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 4 Nov 2014). 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?

MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate (time frame: 1 Month Post-MRI). 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?

On the ClinicalTrials.gov record for NCT01761162, which also lists 1 linked publication.

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 9 Feb 2017.