BradycardiaSAMURAINCT01781078

ImageReady(TM) MR Conditional Pacing System Clinical Study

A study testing MRI and ImageReady System implant in people with Bradycardia and Sinus Node Dysfunction, run by Boston Scientific Corporation at 41 sites in 7 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 objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with the Conditions of Use included in the Boston Scientific MRI Technical Guide Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bradycardia, Sinus Node Dysfunction
What is being tested?: MRI and ImageReady System implant
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 363 participants
Where: 41 sitesin 7 countries
Study dates: Feb 2013to 11 Sep 2019
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject must have the ImageReady System as their initial (de novo) pacing system implant
Subject has a Class I or II indication for implantation of a single or dual chamber pacemaker according to the ACC/AHA/HRS, or ESC guidelines, as appropriate per geography
Subject is able and willing to undergo an MRI scan without intravenous sedation
Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Who cannot join

Subject has or has had any pacing or ICD system implants
Subject has any MR Unsafe implants or devices with an unknown MR status, including MR Unsafe sternal wires, neurostimulators, biostimulator, metals or alloys, per labeling of each implant
Subject has any MR Conditional implants or devices that impact the ability to conduct this protocol
Subject needs or will need another MR scan within 14 weeks of system implant, other than that required by the SAMURAI Study
Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
Subject has a mechanical tricuspid heart valve

Show all 15Show fewer

Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries* that are not in conflict and do not affect the following:
Schedule of procedures for the SAMURAI Study (i.e. should not cause additional or missed visits);
SAMURAI Study outcome (i.e. involve medications that could affect pacing thresholds);
Conduct of the SAMURAI Study per GCP/ ISO 14155:2011/ local regulations
Subjects with documented permanent or persistent AF where the physician intends to implant a dual chamber pulse generator (single chamber VVIR pulse generators are acceptable)
Subject is currently on the active heart transplant list
Subject has documented life expectancy of less than 12 months
Women of childbearing potential who are or might be pregnant at the time of study enrollment or ImageReady MR Conditional Pacing System implant (method of assessment upon physician's discretion)
Subjects currently requiring dialysis

Trial locations and contacts

41 sites in 7 countries.

Country

City, postcode or hospital

41 sites in 7 countries

United States29 sites

Emory University Hospital
Atlanta, Georgia, 30322
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Billings Clinic
Billings, Montana, 59101
Martha Jefferson Hospital
Charlottesville, Virginia, 22911
University of Chicago Hospital
Chicago, Illinois, 60637
OhioHealth Research and Innovation Institute
Columbus, Ohio, 43214
Medical City Dallas Hospital
Dallas, Texas, 75230
St Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, 55805
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Hackensack University Medical Center
Hackensack, New Jersey, 07601
USC Medical Center
Los Angeles, California, 90033
Banner Heart Hospital
Mesa, Arizona, 85206
Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Orlando Regional Medical Center
Orlando, Florida, 32806
Abington Memorial Hospital
Philadelphia, Pennsylvania, 19001
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth University Health System
Richmond, Virginia, 23219
William Beaumont Hospital
Royal Oak, Michigan, 48098
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102
University of California, San Francisco
San Francisco, California, 94143
University of Washington Medical Center
Seattle, Washington, 98195
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, 57108
Trinity West Hospital
Steubenville, Ohio, 43952
University Community Hospital
Trinity, Florida, 34655
Trinity Mother Health Systems
Tyler, Texas, 75701
Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

Israel4 sites

Hillel Yaffe Medical Center
Hadera
Rambam Medical Center
Haifa, 31096
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Sheba Medical Center
Tel HaShomer

Other trials in Israel

Singapore3 sites

National Heart Centre
Singapore, 168752
National University Hospital, Singapore
Singapore
Tan Tock Seng Hospital
Singapore

Other trials in Singapore

Malaysia2 sites

Institut Jantung Negara
Kuala Lumpur, 50400
University Malaya Medical Center
Kuala Lumpur, 50603

Other trials in Malaysia

Australia1 site

St Vincent's Hospital
Melbourne, Victoria

Other trials in Australia

Canada1 site

Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Ste Foy, Quebec

Other trials in Canada

China1 site

Queen Mary Hospital
Hong Kong, Hong Kong, 00000

Other trials in China

About this study

Conditions: Bradycardia, Sinus Node Dysfunction
Being tested: MRI, ImageReady System implant
Keywords: Single chamber pacing, Dual chamber pacing, MRI, MR scans
Medical subject headings: Bradycardia, Sick Sinus Syndrome

What participants receive

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

MRIRadiation
Also called MR Scan
The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
ImageReady System implantDevice
Also called Single chamber pacemaker implant, Dual chamber pacemaker implant, Pace/ Sense pacemaker lead implant
Pacemaker and lead(s) implant

Study groups in NCT01781078
Study group	Role	What they receive
MRI Group	Experimental	Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant. Receives: Radiation: MRI; Device: ImageReady System implant
Control Group	Experimental	Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups. Receives: Device: ImageReady System implant

What is being measured

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

Proportion of Participants Without MR Scan-related Complications
The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.
Measured: MRI Visit + 1 Month
Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit
The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up.
Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups.
Measured: MRI + 1 Month Visit
Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit
The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint.
Measured: MRI + 1 Month Visit

Secondary outcomes (1)

Proportion of Participants Without ImageReady System-related Complications
Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for all subjects who underwent an implant procedure and and reached 91 days of follow-up.
Measured: 3 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 201311 Sep 2019

First posted31 Jan 2013 (estimated)
Study startFeb 2013
Primary completionOct 2014
Study completion11 Sep 2019

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 Boston Scientific CorporationThe 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 363 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01781078
Sponsor's protocol ID: BSC-CDM00047737
Acronym: SAMURAI
Status last verified: Nov 2019
First submitted: 25 Jan 2013
Last updated: 3 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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All Bradycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ImageReady(TM) MR Conditional Pacing System Clinical Study
ClinicalTrials.gov ID: NCT01781078
Acronym / sponsor ID: SAMURAI / BSC-CDM00047737
Conditions: Bradycardia, Sinus Node Dysfunction
Keywords: Single chamber pacing, Dual chamber pacing, MRI, MR scans
Study type: Interventional
Recruitment status: Completed
Enrolment: 363 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Oct 2014 (actual)
Study completion: 11 Sep 2019 (actual)
First posted: 31 Jan 2013 (estimated)
Results: Posted 11 Apr 2017

Clinical summary

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

Study design

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

Arm	Type	Receives
MRI Group	Experimental	Radiation: MRI, Device: ImageReady System implantThose subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
Control Group	Experimental	Device: ImageReady System implantThose subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject must have the ImageReady System as their initial (de novo) pacing system implant
Subject has a Class I or II indication for implantation of a single or dual chamber pacemaker according to the ACC/AHA/HRS, or ESC guidelines, as appropriate per geography
Subject is able and willing to undergo an MRI scan without intravenous sedation
Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Key exclusion criteria (15 listed)

Subject has or has had any pacing or ICD system implants
Subject has any MR Unsafe implants or devices with an unknown MR status, including MR Unsafe sternal wires, neurostimulators, biostimulator, metals or alloys, per labeling of each implant
Subject has any MR Conditional implants or devices that impact the ability to conduct this protocol
Subject needs or will need another MR scan within 14 weeks of system implant, other than that required by the SAMURAI Study
Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)

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
MRIAlso: MR ScanThe study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment	Radiation	MRI Group
ImageReady System implantAlso: Single chamber pacemaker implant, Dual chamber pacemaker implant, Pace/ Sense pacemaker lead implantPacemaker and lead(s) implant	Device	Control Group, MRI Group

Primary outcome

Proportion of Participants Without MR Scan-related Complications
Time frame: MRI Visit + 1 Month
The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.
Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit
Time frame: MRI + 1 Month Visit
The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up. Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups.
Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit
Time frame: MRI + 1 Month Visit
The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint.

1 secondary outcome

Proportion of Participants Without ImageReady System-related Complications
Time frame: 3 months post implant

Results and safety

Results posted to the registry on 11 Apr 2017, 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	229	217
Control Group	118	113
Patients Withdrawn Prior to Randomization	16	0

Primary outcome: Proportion of Participants Without MR Scan-related Complications

Time frame: MRI Visit + 1 Month. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	MRI Group n = 180
Value	100 (100 to 100)

Population analysed: The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who underwent any portion of the MRI scan sequences and did not have a medically necessary scan performed prior to the MRI visit + 1 month follow-up.

Primary outcome: Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit

Time frame: MRI + 1 Month Visit. Number. Unit: % of participants with success

Measure	MRI Group n = 167	Control Group n = 96
Value	98.2	97.9

MRI Group vs Control Group: difference: -0.3, p <0.0001, Farrington-Manning score test

Population analysed: For the per-protocol analysis, a total of 96 Control Group subjects and 167 MRI Group subjects had paired threshold measurements and met the inclusion criteria.

Primary outcome: Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit

Time frame: MRI + 1 Month Visit. Number. Unit: % of participants with success

Measure	Control Group n = 169	MRI Group n = 287
Right Atrium (RA)	96.2	96.3
Right Ventricle (RV)	96.7	96.7

Control Group vs MRI Group: difference: -0.1, p = 0.0006, Farrington-Manning score test
Control Group vs MRI Group: difference: -0.0, p = 0.0002, Farrington-Manning score test

Population analysed: Right Atrium: a total of 78 Control Group subjects and 135 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria. Right Ventricle: a total of 91 Control Group subjects and 152 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events are collected from enrollment through whole course of the study. Long-term follow-up is ongoing; subjects enrolled in SAMURAI study will be followed for 5 years post-implant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRI Group	123 of 229 (53.7%)	163 of 229 (71.2%)	Not reported
Control Group	67 of 118 (56.8%)	82 of 118 (69.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bradycardia

Active, not recruitingObservational study
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Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
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Belgo-Luxembourg Leadless PM Registry
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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.

Ronald Berger, MD, PhD principal investigator

Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287

41 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MRI and ImageReady System implant in people with Bradycardia and Sinus Node Dysfunction, run by Boston Scientific Corporation at 41 sites in 7 countries.

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 15 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 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Israel, Singapore, Malaysia, Australia and 2 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 Apr 2017). 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?

Proportion of Participants Without MR Scan-related Complications (time frame: MRI Visit + 1 Month). 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 NCT01781078.

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 3 Dec 2019.