ImageReady(TM) MR Conditional Pacing System Clinical Study - Full Text View

Purpose

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

Condition	Intervention
Bradycardia Sinus Node Dysfunction	Radiation: MRI Device: ImageReady System implant

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	ImageReady(TM) MR Conditional Pacing System Clinical Study

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans Nuclear Scans

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Proportion of participants without MR scan-related complications [ Time Frame: MRI Visit + 1 Month ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Proportion of participants without ImageReady System-related complications [ Time Frame: 3 months post implant ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	363
Study Start Date:	February 2013
Estimated Study Completion Date:	February 2019
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MRI Group Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.	Radiation: MRI The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment Other Names: MRI 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
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.	Device: ImageReady System implant Pacemaker and lead(s) implant Other Names: Single chamber pacemaker implant Dual chamber pacemaker implant Pace/ Sense pacemaker lead implant

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781078

Contacts

Contact: Ronald Berger, MD, PhD

410-614-2751

rberger@jhmi.edu

Locations

Malaysia
Institut Jantung Negara	Recruiting
Kuala Lumpur, Malaysia, 50400
Contact: Razali Omar, MD razali@ijn.com.my
Contact: Irni Yusnida 60-3-2617-8200 irni@ijn.com.my

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:

Ronald Berger, MD, PhD

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

More Information

No publications provided

Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT01781078 History of Changes
Other Study ID Numbers:	BSC-CDM00047737
Study First Received:	January 25, 2013
Last Updated:	February 14, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

Single chamber pacing
Dual chamber pacing
MRI
MR scans

Additional relevant MeSH terms:

Sick Sinus Syndrome
Bradycardia
Arrhythmia, Sinus
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013

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