Clinical trial NCT01781078: ImageReady(TM) MR Conditional Pacing System Clinical Study
Official title: ImageReady(TM) MR Conditional Pacing System Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Sinus Node Dysfunction
Keywords: Single chamber pacing
Dual chamber pacing
MRI
MR scans
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-31
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Proportion of Participants Without MR Scan-related Complications
timeFrame: MRI Visit + 1 Month
measure: Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit
timeFrame: MRI + 1 Month Visit
measure: Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit
timeFrame: MRI + 1 Month Visit
Secondary outcomes:
measure: Proportion of Participants Without ImageReady System-related Complications
timeFrame: 3 months post implant
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Heart Hospital
state: Arizona
city: Los Angeles
country: United States
facility: USC Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Trinity
country: United States
facility: University Community Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Duluth
country: United States
facility: St Mary's Duluth Clinic Regional Heart Center
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute
state: Ohio
city: Steubenville
country: United States
facility: Trinity West Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Heart Hospital of South Dakota
state: South Dakota
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Health Systems
state: Texas
city: Charlottesville
country: United States
facility: Martha Jefferson Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin
state: Wisconsin
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Ste Foy
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
city: Hong Kong
country: China
facility: Queen Mary Hospital
state: Hong Kong
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Tel Aviv
country: Israel
facility: The Tel Aviv Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
city: Singapore
country: Singapore
facility: National Heart Centre
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Johns Hopkins Hospital, Carnegie 530, 600 N. Wolfe St, Baltimore, MD 21287
name: Ronald Berger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: