BradycardiaNCT00433654

EMRI SureScan™ Clinical Study

A study testing Implantable Pulse Generator (IPG) and Pacing Leads (wires) and Magnetic Resonance Imaging (MRI) scan in people with Bradycardia and Slow Heart Beat, run by Medtronic Cardiac Rhythm and Heart Failure at 45 sites in 11 countries.

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 purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch). Read more about this study

Who is it for?: Any age
Conditions the study is for: Bradycardia, Slow Heart Beat
What is being tested?: Implantable Pulse Generator (IPG) and Pacing Leads (wires) and Magnetic Resonance Imaging (MRI) scan
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 484 participants
Where: 45 sitesin 11 countries
Study dates: Feb 2007to Aug 2010
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker.
Subject available for follow-up at study center for length of study.
Subject able and willing to undergo elective MRI scanning without sedation.

Who cannot join

Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.
Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.
Subject with exclusion criteria required by local law.
Subject who intends to participate in another clinical study during this clinical study.

Trial locations and contacts

45 sites in 11 countries.

Country

City, postcode or hospital

45 sites in 11 countries

United States15 sites

Study site
Charlottesville, Virginia
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Des Moines, Iowa
Study site
Erie, Pennsylvania
Study site
Kansas City, Missouri
Study site
Knoxville, Tennessee
Study site
Mineola, New York
Study site
Minneapolis, Minnesota
Study site
Norfolk, Virginia
Study site
Orlando, Florida
Study site
Peachtree City, Georgia
Study site
Redwood City, California
Study site
Salinas, California
Study site
St Louis, Missouri

Other trials in United States

Germany10 sites

Study site
Bad Nauheim
Study site
Bonn
Study site
Dortmund
Study site
Dresden
Study site
Essen
Study site
Göttingen
Study site
Hamburg
Study site
Marburg
Study site
München
Study site
Ulm

Other trials in Germany

Canada6 sites

Study site
Calgary, Alberta
Study site
Kingston, Ontario
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Sainte-Foy, Quebec
Study site
Victoria, British Columbia

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Italy4 sites

Study site
Asti
Study site
Pescia
Study site
Pietra Ligure
Study site
Viterbo

Other trials in Italy

Austria2 sites

Study site
Graz
Study site
Linz

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Belgium2 sites

Study site
Liège
Study site
Mons

Other trials in Belgium

Netherlands2 sites

Study site
Amsterdam
Study site
Nieuwegein

Other trials in Netherlands

Czechia1 site

Study site
Prague

Other trials in Czechia

France1 site

Study site
Rouen

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Switzerland1 site

Study site
Zurich

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United Kingdom1 site

Study site
London

Other trials in United Kingdom

About this study

Official title: EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

Read the detailed description

This study is a prospective, multi-center global study.

Conditions: Bradycardia, Slow Heart Beat
Being tested: Implantable Pulse Generator (IPG) and Pacing Leads (wires), Magnetic Resonance Imaging (MRI) scan
Keywords: Bradycardia, Slow heart beat, Magnetic resonance imaging (MRI)
Medical subject headings: Bradycardia

What participants receive

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

Implantable Pulse Generator (IPG) and Pacing Leads (wires)Device
Pacer and leads
Magnetic Resonance Imaging (MRI) scanOther
One hour MRI scan on the head and lower back.

Study groups in NCT00433654
Study group	Role	What they receive
MRI group	Active comparator	The MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up. Receives: Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires); Other: Magnetic Resonance Imaging (MRI) scan
Control group	Other	The control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up. Receives: Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)

What is being measured

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

Magnetic Resonance Imaging (MRI)-Related Complications
Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.
Measured: MRI scan to one-month post-MRI scan
Atrial Pacing Capture Threshold Success
Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.
Measured: 9-12 week visit to 4-month visit
Ventricular Pacing Capture Threshold Success
Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.
Measured: 9-12 week visit to 4-month visit
Atrial Sensed Amplitude Success
Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).
Measured: 9-12 week visit to 4-month visit
Ventricular Sensed Amplitude Success
Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).
Measured: 9-12 week visit to 4-month visit

Secondary outcomes (11)

Subjects With System-related Complications
Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.
Measured: Implant to 4 Months
System Related Adverse Device Effects Due to Labeling Instructions
Number of participants with adverse device effects (ADEs) that resulted from insufficiencies or inadequacies in the instructions for use or deployment of the device, or from user error. ADE's were investigator-reported.
Measured: Implant through 18 months post-implant
Occurrence of Arrhythmias
Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan
Measured: During the MRI scan
Atrial Lead Impedance Change
Subjects' atrial lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.
Measured: 9-12 week visit and 4-month visit
Ventricular Lead Impedance Change
Subjects' ventricular lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.
Measured: 9-12 week visit and 4-month visit
Atrial Lead Handling Rating
Physicians' rated atrial lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.
Measured: During implant
Ventricular Lead Handling Rating
Physicians' rated ventricular lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.
Measured: During implant
Atrial Pacing Capture Threshold
Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Measured: 3 or 4 months post-implant
Ventricular Pacing Capture Threshold
Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.
Measured: 3 or 4 months post-implant
Atrial Sensed Amplitude
Average atrial sensed amplitude.
Measured: 3 or 4 months post-implant
Ventricular Sensed Amplitude
Average ventricular sensed amplitude.
Measured: 3 or 4 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 2007Aug 2010

First posted12 Feb 2007 (estimated)
Study startFeb 2007
Primary completionNov 2008
Study completionAug 2010

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 BradycardiaStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 484 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00433654
Sponsor's protocol ID: 212
Status last verified: Jul 2011
First submitted: 2 Feb 2007
Last updated: 15 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Sutton R, Kanal E, Wilkoff BL, Bello D, Luechinger R, Jenniskens I, Hull M, Sommer T. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. 2008 Dec 2;9:68. doi: 10.1186/1745-6215-9-68.
PubMed 19055703

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?

See locations

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BIO|STREAM.CSP Study
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All Bradycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation
ClinicalTrials.gov ID: NCT00433654
Acronym / sponsor ID: 212
Conditions: Bradycardia, Slow Heart Beat
Keywords: Bradycardia, Slow heart beat, Magnetic resonance imaging (MRI)
Study type: Interventional
Recruitment status: Completed
Enrolment: 484 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Nov 2008 (actual)
Study completion: Aug 2010 (actual)
First posted: 12 Feb 2007 (estimated)
Results: Posted 11 Aug 2011

Clinical summary

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

Detailed description

This study is a prospective, multi-center global study.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MRI group	Active comparator	Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires), Other: Magnetic Resonance Imaging (MRI) scanThe MRI group underwent a one-hour MRI scan at the 9-12 weeks post-implant follow-up.
Control group	Other	Device: Implantable Pulse Generator (IPG) and Pacing Leads (wires)The control group waited for one hour (no MRI) at the 9-12 weeks post-implant follow-up.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker.
Subject available for follow-up at study center for length of study.
Subject able and willing to undergo elective MRI scanning without sedation.

Key exclusion criteria (5 listed)

Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.
Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.
Subject with exclusion criteria required by local law.
Subject who intends to participate in another clinical study during this clinical study.

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
Implantable Pulse Generator (IPG) and Pacing Leads (wires)Pacer and leads	Device	Control group, MRI group
Magnetic Resonance Imaging (MRI) scanOne hour MRI scan on the head and lower back.	Other	MRI group

Primary outcome

Magnetic Resonance Imaging (MRI)-Related Complications
Time frame: MRI scan to one-month post-MRI scan
Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.
Atrial Pacing Capture Threshold Success
Time frame: 9-12 week visit to 4-month visit
Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.
Ventricular Pacing Capture Threshold Success
Time frame: 9-12 week visit to 4-month visit
Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.
Atrial Sensed Amplitude Success
Time frame: 9-12 week visit to 4-month visit
Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).
Ventricular Sensed Amplitude Success
Time frame: 9-12 week visit to 4-month visit
Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).

11 secondary outcomes

Subjects With System-related Complications
Time frame: Implant to 4 Months
System Related Adverse Device Effects Due to Labeling Instructions
Time frame: Implant through 18 months post-implant
Occurrence of Arrhythmias
Time frame: During the MRI scan
Atrial Lead Impedance Change
Time frame: 9-12 week visit and 4-month visit
Ventricular Lead Impedance Change
Time frame: 9-12 week visit and 4-month visit
Atrial Lead Handling Rating
Time frame: During implant
Ventricular Lead Handling Rating
Time frame: During implant
Atrial Pacing Capture Threshold
Time frame: 3 or 4 months post-implant
Ventricular Pacing Capture Threshold
Time frame: 3 or 4 months post-implant
Atrial Sensed Amplitude
Time frame: 3 or 4 months post-implant
Ventricular Sensed Amplitude
Time frame: 3 or 4 months post-implant

Results and safety

Results posted to the registry on 11 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MRI Group	258	243
Control Group	206	201

Primary outcome: Magnetic Resonance Imaging (MRI)-Related Complications

Time frame: MRI scan to one-month post-MRI scan. Number. Unit: participants

Measure	MRI Group n = 211
Value	0

MRI Group: Percentage: 0, p <0.001, exact test of binomial proportions

Population analysed: Subjects who underwent an MRI scan following study protocol-specified instructions are included. Of the 243 subjects who completed a one-month post-MRI (4-month) visit, 32 did not complete the MRI scan according to the protocol instructions, and are not included.

Primary outcome: Atrial Pacing Capture Threshold Success

Time frame: 9-12 week visit to 4-month visit. Number. Unit: participants

Measure	MRI Group n = 165	Control Group n = 164
Value	165	164

MRI Group vs Control Group: Difference in percentages: 0, Farrington-Manning

Population analysed: Subjects were excluded from this analysis if: they did not have atrial pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.

Primary outcome: Ventricular Pacing Capture Threshold Success

Time frame: 9-12 week visit to 4-month visit. Number. Unit: participants

Measure	MRI Group n = 190	Control Group n = 184
Value	190	183

MRI Group vs Control Group: Difference in percentages: 0.5, p <0.001, Farrington-Manning

Population analysed: Subjects were excluded from this analysis if: they did not have ventricular pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.

Primary outcome: Atrial Sensed Amplitude Success

Time frame: 9-12 week visit to 4-month visit. Number. Unit: participants

Measure	MRI Group n = 131	Control Group n = 139
Value	124	129

MRI Group vs Control Group: Difference in percentages: 1.9, p <0.001, Farrington-Manning

Population analysed: Subjects were excluded from this analysis if: they did not have atrial sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week atrial sensed amplitude was less than 1.5 mV.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 31 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRI Group	117 of 260 (45%)	24 of 260 (9.2%)	Not reported
Control Group	77 of 207 (37.2%)	19 of 207 (9.2%)	Not reported
Non-randomized	3 of 20 (15%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): Comparisons with a historical control (5076 Lead) were performed for secondary objectives #11-#16, however the results database is currently only designed to allow for reporting of participants specifically enrolled as part of this protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19055703Sutton R, Kanal E, Wilkoff BL, Bello D, Luechinger R, Jenniskens I, Hull M, Sommer T. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. 2008 Dec 2;9:68. doi: 10.1186/1745-6215-9-68.

Related trials for Bradycardia

Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
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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.

EMRI SureScan Clinical Study Team study chair

Medtronic

45 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 5 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Germany, Canada, Italy, Austria and 6 more countries. 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 11 Aug 2011). 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?

Magnetic Resonance Imaging (MRI)-Related Complications (time frame: MRI scan to one-month post-MRI scan). 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 NCT00433654, 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 15 Sep 2025.