Magnetic Resonance Imaging (MRI)NCT01755143

Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment

A study testing Magnetic Resonance Imaging scan sequences of the head, neck, and chest and Pacemaker System in people with Magnetic Resonance Imaging (MRI) and Cardiac Pacing, run by Medtronic Cardiac Rhythm and Heart Failure at 36 sites in 19 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 study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan. Read more about this study

Who is it for?: Any age
Conditions the study is for: Magnetic Resonance Imaging (MRI), Cardiac Pacing
What is being tested?: Magnetic Resonance Imaging scan sequences of the head, neck, and chest and Pacemaker System
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 266 participants
Where: 36 sitesin 19 countries
Study dates: Dec 2012to Oct 2013
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

Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines
Subjects who are able to undergo a pectoral implant
Subjects who:
are receiving an IPG for the first time, OR
are receiving a replacement IPG connected to two previously- implanted (atrial and ventricular) Model 5076 leads
Subjects who are able and willing to undergo elective MRI scanning without sedation
Subjects who are geographically stable and available for follow-up at the study site for the length of the study

Who cannot join

Subjects with a mechanical tricuspid heart valve.
Subjects with a history of significant tricuspid valvular disease.
Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
Subjects who require a legally authorized representative to obtain consent.
Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads
Subjects who are immediate candidates for an ICD.

Show all 13Show fewer

Subjects who require an indicated MRI scan, other than those specifically described in the study, before the one-month post MRI/waiting period follow-up.
Subjects with previously implanted active medical devices (exception Model 5076 Lead and Advisa MRI IPG).
Subjects with a non-MRI compatible device (such as ICDs or neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
Subjects with medical conditions that preclude the testing required by the protocol or limit study participation.
Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study.
Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.
Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).

Trial locations and contacts

36 sites in 19 countries.

Country

City, postcode or hospital

36 sites in 19 countries

India7 sites

Sri Jayadeva Institute of Cardiovascular Sciences and Research
Bangalore
Post Graduate Institute of Medical Education & Research
Chandigarh, 160012
Medanta The Medicity
Gurgaon, Haryana, 122041
Fortis Escorts Hospital
Jaipur, 302017
Holy Family Hospital
Mumbai, 400050
All India Institute of Medical Sciences
New Delhi, 110029
Dayanand Medical College
Punjab, 141001

Other trials in India

Germany4 sites

Klinikum Links der Weser
Bremen, 28277
Praxisklinik Herz und Gefässe
Dresden, 01099
Universitätsklinikum Jena
Jena, 07747
Universitätsklinikum Ulm
Ulm, 89081

Other trials in Germany

Netherlands3 sites

St. Antonius Ziekenhuis - Locatie Nieuwegein
Nieuwegein, 3435
Maasstad Ziekenhuis
Rotterdam, 3078
HagaZiekenhuis - Locatie Leyweg
The Hague, 2545

Other trials in Netherlands

Australia2 sites

Flinders Medical Centre
Bedford Park, 5042
Saint George Hospital
Kogarah, New South Wales, 2217

Other trials in Australia

Austria2 sites

Landesklinikum St. Pölten
Sankt Pölten, 3100
Wilhelminenspital
Vienna, 1160

Other trials in Austria

Belgium2 sites

Les Cliniques du Sud Luxembourg Cliniques Saint Joseph
Arlon, 6700
Hôpital Saint-Joseph
Gilly, 6060

Other trials in Belgium

Serbia2 sites

Klinicki Centar Srbije
Belgrade, 11000
Institut za Kardiovaskularne Bolesti Vojvodine
Kamenitz, 21204

Other trials in Serbia

Switzerland2 sites

HFR Fribourg - Hôpital cantonal
Fribourg, 1708
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011

Other trials in Switzerland

Taiwan2 sites

National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217

Other trials in Taiwan

Chile1 site

Hospital Clínico Pontificia Universidad Católica
Santiago, 8320000

Other trials in Chile

China1 site

Prince of Wales Hospital Hong Kong
Hong Kong

Other trials in China

Colombia1 site

Fundacion Cardioinfantil
Bogotá, 102973

Other trials in Colombia

Hong Kong1 site

Queen Mary Hospital
Hong Kong

Other trials in Hong Kong

Portugal1 site

Centro Hospitalar do Porto
Porto, 4099-001

Other trials in Portugal

Saudi Arabia1 site

Prince Sultan Cardiac Center
Riyadh

Other trials in Saudi Arabia

Singapore1 site

National Heart Centre Singapore
Singapore, 168752

Other trials in Singapore

Slovakia1 site

Narodny ustav srdcovych a cievnych chorob
Bratislava, 83348

Other trials in Slovakia

South Africa1 site

Netcare Unitas Hospital
Pretoria, 0140

Other trials in South Africa

Spain1 site

Hospital Universitari Clínic de Barcelona
Barcelona, 08036

Other trials in Spain

About this study

Official title: CapSureFix® Novus Model 5076 Lead MRI Study

Conditions: Magnetic Resonance Imaging (MRI), Cardiac Pacing
Being tested: Magnetic Resonance Imaging scan sequences of the head, neck, and chest, Pacemaker System

What participants receive

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

Magnetic Resonance Imaging scan sequences of the head, neck, and chestOther
Pacemaker SystemDevice
Also called Model 5076 Lead, Advisa MRI Pacemaker

Study groups in NCT01755143
Study group	Role	What they receive
MRI Group	Experimental	Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant. Receives: Other: Magnetic Resonance Imaging scan sequences of the head, neck, and chest; Device: Pacemaker System
Control Group	Sham comparator	Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit. Receives: Device: Pacemaker System

What is being measured

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

MRI-related Complication Free Rate
Number of patients free of MRI-related complications
Measured: MRI scan to one month later
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds
Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
Measured: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds
Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
Measured: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period

Secondary outcomes (3)

Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude
Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.
Measured: Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period
Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the Adverse Events Adjudication Committee
Measured: During MRI scans (9-12 weeks post-implant)
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude
Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.
Measured: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period

Timeline

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

Dec 2012Oct 2013

First posted24 Dec 2012 (estimated)
Study startDec 2012
Primary completionOct 2013
Study completionOct 2013

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 Magnetic Resonance Imaging (MRI)Studies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 266 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01755143
Sponsor's protocol ID: 5076 MRI
Status last verified: Jun 2015
First submitted: 18 Dec 2012
Last updated: 20 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CapSureFix® Novus Model 5076 Lead MRI Study
ClinicalTrials.gov ID: NCT01755143
Acronym / sponsor ID: 5076 MRI
Conditions: Magnetic Resonance Imaging (MRI), Cardiac Pacing
Study type: Interventional
Recruitment status: Completed
Enrolment: 266 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 24 Dec 2012 (estimated)
Results: Posted 20 Jul 2015

Clinical summary

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

Study design

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

Arm	Type	Receives
MRI Group	Experimental	Other: Magnetic Resonance Imaging scan sequences of the head, neck, and chest, Device: Pacemaker SystemSubjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.
Control Group	Sham comparator	Device: Pacemaker SystemSubjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.

Who may qualify

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

Key inclusion criteria (7 listed)

Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines
Subjects who are able to undergo a pectoral implant
Subjects who:
are receiving an IPG for the first time, OR
are receiving a replacement IPG connected to two previously- implanted (atrial and ventricular) Model 5076 leads

Key exclusion criteria (13 listed)

Subjects with a mechanical tricuspid heart valve.
Subjects with a history of significant tricuspid valvular disease.
Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
Subjects who require a legally authorized representative to obtain consent.
Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads

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
Magnetic Resonance Imaging scan sequences of the head, neck, and chest	Other	MRI Group
Pacemaker SystemAlso: Model 5076 Lead, Advisa MRI Pacemaker	Device	Control Group, MRI Group

Primary outcome

MRI-related Complication Free Rate
Time frame: MRI scan to one month later
Number of patients free of MRI-related complications
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds
Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds
Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.

3 secondary outcomes

Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude
Time frame: Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period
Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
Time frame: During MRI scans (9-12 weeks post-implant)
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude
Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period

Results and safety

Results posted to the registry on 20 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
MRI Group	177	166
Control Group	89	86

Primary outcome: MRI-related Complication Free Rate

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

Measure	MRI Group n = 156
Value	156

MRI Group: Percentage: 100, p <0.0001, exact test of binomial proportions

Population analysed: Patients who underwent an MRI

Primary outcome: Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds

Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period. Number. Unit: participants

Measure	MRI Group n = 142	Control Group n = 80
Value	142	80

MRI Group vs Control Group: Risk Difference (RD): 0, Farrington-Manning test

Population analysed: To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.

Primary outcome: Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds

Time frame: Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period. Number. Unit: participants

Measure	MRI Group n = 153	Control Group n = 82
Value	152	82

MRI Group vs Control Group: Risk Difference (RD): -0.7 (95% CI -5.4 to 4.1), p <0.0001, Farrington-Manning test

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Implant to six-months post-implant. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRI Group	28 of 177 (15.8%)	0 of 177 (0%)	Not reported
Control Group	6 of 89 (6.7%)	0 of 89 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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

36 sites in 19 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 7 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 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in India, Germany, Netherlands, Australia, Austria and 14 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. Some participants in this study may receive a placebo. 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 20 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-related Complication Free Rate (time frame: MRI scan to one month later). The study lists 3 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 NCT01755143.

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 20 Jul 2015.