ImageReady(TM) MR Conditional Pacing System Clinical Study

Not Applicable

Completed

• Conditions: Sinus Node Dysfunction; Bradycardia
• Interventions: Radiation: MRI; Device: ImageReady System implant

• Registration Number: NCT01781078
• Lead Sponsor: Boston Scientific Corporation

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-31
• Study Start: 2013-02
• Primary Completion: 2014-10
• Results First Submitted: 2017-04-07
• Results First Submitted QC: 2017-04-07
• Results First Posted: 2017-04-11
• Study Completion: 2019-09-11
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 363

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI Group	ImageReady System implant	Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.
Control Group	ImageReady System implant	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.
MRI Group	MRI	Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Without MR Scan-related Complications	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Without ImageReady System-related Complications	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.

Trial Locations

Locations (41)

OhioHealth Research and Innovation Institute; 🇺🇸 Columbus, Ohio, United States

United Heart and Vascular Clinic; 🇺🇸 Saint Paul, Minnesota, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

University of Chicago Hospital; 🇺🇸 Chicago, Illinois, United States

USC Medical Center; 🇺🇸 Los Angeles, California, United States

University Community Hospital; 🇺🇸 Trinity, Florida, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Orlando Regional Medical Center; 🇺🇸 Orlando, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Alexian Brothers Medical Center; 🇺🇸 Elk Grove Village, Illinois, United States

St Mary's Duluth Clinic Regional Heart Center; 🇺🇸 Duluth, Minnesota, United States

Long Island Jewish Medical Center; 🇺🇸 New Hyde Park, New York, United States

Trinity West Hospital; 🇺🇸 Steubenville, Ohio, United States

Abington Memorial Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Medical City Dallas Hospital; 🇺🇸 Dallas, Texas, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

Trinity Mother Health Systems; 🇺🇸 Tyler, Texas, United States

Virginia Commonwealth University Health System; 🇺🇸 Richmond, Virginia, United States

Martha Jefferson Hospital; 🇺🇸 Charlottesville, Virginia, United States

Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Rambam Medical Center; 🇮🇱 Haifa, Israel

The Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Institut Jantung Negara; 🇲🇾 Kuala Lumpur, Malaysia

University Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia

Queen Mary Hospital; 🇨🇳 Hong Kong, Hong Kong, China

Banner Heart Hospital; 🇺🇸 Mesa, Arizona, United States

National University Hospital, Singapore; 🇸🇬 Singapore, Singapore

St Vincent's Hospital; 🇦🇺 Melbourne, Victoria, Australia

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel

Billings Clinic; 🇺🇸 Billings, Montana, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

National Heart Centre; 🇸🇬 Singapore, Singapore

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Avera Heart Hospital of South Dakota; 🇺🇸 Sioux Falls, South Dakota, United States

Institut Universitaire de Cardiologie et de Pneumologie de Quebec; 🇨🇦 Ste Foy, Quebec, Canada

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore