ImageReady(TM) MR Conditional Pacing System Clinical Study (SAMURAI)

• ClinicalTrials.gov Identifier: NCT01781078
• Recruitment Status: Completed
• First Posted: January 31, 2013
• Results First Posted: April 11, 2017
• Last Update Posted: December 3, 2019
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Tracking Information

• First Submitted Date: January 25, 2013
• First Posted Date: January 31, 2013
• Results First Submitted Date: April 7, 2017
• Results First Posted Date: April 11, 2017
• Last Update Posted Date: December 3, 2019
• Study Start Date: February 2013
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2017)

• 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.

Original Primary Outcome Measures (submitted: January 29, 2013)

• 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.
• Change in pacing threshold from pre-MRI scan/ Control Group Visit to MRI + 1 Month 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.
• Change in sensed amplitude from pre-MRI scan/ Control Group Visit to MRI + 1 Month 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.

Current Secondary Outcome Measures (submitted: April 7, 2017)

Proportion of Participants Without ImageReady System-related Complications [ Time Frame: 3 months post implant ]

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.

Original Secondary Outcome Measures (submitted: January 29, 2013)

Proportion of participants without ImageReady System-related complications [ Time Frame: 3 months post implant ]

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 subjects in both the MRI and Control groups.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ImageReady(TM) MR Conditional Pacing System Clinical Study
• Official Title: ImageReady(TM) MR Conditional Pacing System Clinical Study
• Brief 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Bradycardia
• Sinus Node Dysfunction

Intervention

• Radiation: MRI
  The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
  Other Name: MR Scan
• Device: ImageReady System implant
  Pacemaker and lead(s) implant
  Other Names:

  • Single chamber pacemaker implant
  • Dual chamber pacemaker implant
  • Pace/ Sense pacemaker lead implant

Study Arms

• Experimental: MRI Group
  Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
  Interventions:

  • Radiation: MRI
  • Device: ImageReady System implant
• Experimental: Control Group
  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.
  Intervention: Device: ImageReady System implant

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 29, 2013): 363
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 11, 2019
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, China, Israel, Malaysia, Singapore, United States

Administrative Information

• NCT Number: NCT01781078
• Other Study ID Numbers: BSC-CDM00047737
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Boston Scientific Corporation
• Study Sponsor: Boston Scientific Corporation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ronald Berger, MD, PhD; Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287

• PRS Account: Boston Scientific Corporation
• Verification Date: November 2019