Magnetic Resonance Imaging (MRI); Cardiac PacingNCT02009696

ProMRI Study of the Entovis Pacemaker System (Phase B)

An observational study of Magnetic Resonance Imaging (MRI); Cardiac Pacing, run by Biotronik, Inc. at 32 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 (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Magnetic Resonance Imaging (MRI); Cardiac Pacing
What is being tested?: Patients with a ProMRI Pacemaker System and Magnetic Resonance Imaging (MRI) scan
Type of treatment: Medical device
How many people: 221 participants
Where: 32 sitesUnited States
Study dates: Dec 2013to Jan 2015
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
Able and willing to complete MRI testing
Able to provide written informed consent
Available for follow-up visit at the study site
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.)

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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

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

United States32 sites

Study site
Amarillo, Texas, 79106
Study site
Ann Arbor, Michigan, 48109
Study site
Boston, Massachusetts, 02114
Study site
Burlington, Massachusetts, 01805
Study site
Concord, California, 94520
Study site
Cumberland, Maryland, 21502
Study site
Flushing, New York, 11355
Study site
Greenville, South Carolina, 29605
Study site
Greenville, South Carolina, 29607
Study site
Iowa City, Iowa, 52242
Study site
Kansas City, Missouri, 64132
Study site
Lafayette, Louisiana, 70503
Study site
Mechanicsville, Virginia, 23116
Study site
New Haven, Connecticut, 06510
Study site
New York, New York, 10016
Study site
Newark, Delaware, 19702-5438
Study site
Newport Beach, California, 92663
Study site
Newtown, Pennsylvania, 18940
Study site
Phoenix, Arizona, 85018
Study site
Rancho Mirage, California, 92270
Study site
Salem, Oregon, 97301
Study site
Scottsdale, Arizona, 85251
Study site
Spokane, Washington, 99204
Study site
St Louis, Missouri, 63110
Study site
The Bronx, New York, 10463
Study site
Toledo, Ohio, 43615
Study site
Valparaiso, Indiana, 46383
Study site
Virginia Beach, Virginia, 23454
Study site
Washington D.C., District of Columbia, 20010
Study site
Winston-Salem, North Carolina, 27157
Study site
Worcester, Massachusetts, 01655
Study site
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.

Conditions: Magnetic Resonance Imaging (MRI); Cardiac Pacing
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 heart/chest or thoracic spine.

Study groups in NCT02009696
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 with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.
Measured: Between Pre-MRI and 1 Month Post-MRI
Percentage of Participants Free of Ventricular Pacing Threshold Rise
Evaluate the percentage of ventricular pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Measured: Between Pre-MRI and 1 Month Post-MRI
Percentage of Participants Free of P-wave Sensing Attenuation
Evaluate the percentage of subjects who experience P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Measured: Between Pre-MRI and 1 Month Post-MRI
Percentage of Participants Free of R-wave Sensing Attenuation
Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Measured: Between Pre-MRI and 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.

Dec 2013Jan 2015

First posted12 Dec 2013 (estimated)
Study startDec 2013
Primary completionNov 2014
Study completionJan 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Magnetic Resonance Imaging (MRI); Cardiac PacingStudies 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: 221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02009696
Sponsor's protocol ID: G120226 (Phase B)
Status last verified: Oct 2015
First submitted: 9 Dec 2013
Last updated: 25 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Bailey WM, Mazur A, McCotter C, Woodard PK, Rosenthal L, Johnson W, Mela T; ProMRI Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2016 Feb;13(2):464-71. doi: 10.1016/j.hrthm.2015.09.021. Epub 2015 Sep 25.
PubMed 26409098

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ProMRI Study of the Entovis Pacemaker System (Phase B)
ClinicalTrials.gov ID: NCT02009696
Acronym / sponsor ID: G120226 (Phase B)
Conditions: Magnetic Resonance Imaging (MRI); Cardiac Pacing
Study type: Observational
Recruitment status: Completed
Enrolment: 221 participants (actual)
Lead sponsor: Biotronik, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Nov 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 12 Dec 2013 (estimated)
Results: Posted 10 Jul 2015

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 (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.

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 (21 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
Able and willing to complete MRI testing
Able to provide written informed consent
Available for follow-up visit at the study site

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 heart/chest or thoracic spine.	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: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of atrial pacing leads with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of Ventricular Pacing Threshold Rise
Time frame: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of ventricular pacing leads with a 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: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of subjects who experience 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: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.

Results and safety

Results posted to the registry on 10 Jul 2015, 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	221	219

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 = 221
Value	99.5 (97.5 to 100)

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

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

Measure	Pacemaker Therapy n = 194
Value	100 (98.1 to 100)

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

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

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

Measure	Pacemaker Therapy n = 206
Value	100 (98.2 to 100)

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

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

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

Measure	Pacemaker Therapy n = 170
Value	98.2 (94.9 to 99.6)

Population analysed: Number of participants with an atrial lead and same sensing polarity (either uni- or bi-polar) 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	22 of 221 (10%)	38 of 221 (17.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26409098Bailey WM, Mazur A, McCotter C, Woodard PK, Rosenthal L, Johnson W, Mela T; ProMRI Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2016 Feb;13(2):464-71. doi: 10.1016/j.hrthm.2015.09.021. Epub 2015 Sep 25.

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.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Magnetic Resonance Imaging (MRI); Cardiac Pacing, run by Biotronik, Inc. at 32 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 21 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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 10 Jul 2015). 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 NCT02009696, 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 25 Nov 2015.