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ImageReady(TM) MR Conditional Pacing System Clinical Study | Clinical Trials | Clareo Health

COMPLETEDNA

ImageReady(TM) MR Conditional Pacing System Clinical Study

NCT01781078•Boston Scientific Corporation

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (41)

Banner Heart Hospital

Mesa, Arizona, United States

USC Medical Center

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Orlando Regional Medical Center

Orlando, Florida, United States

University Community Hospital

Trinity, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

University of Chicago Hospital

Chicago, Illinois, United States

Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Key Dates

Start Date

February 1, 2013

Primary Completion Date

October 1, 2014

Completion Date

September 11, 2019

Last Updated

December 3, 2019

Enrollment

363

ACTUAL participants

Conditions

BradycardiaSinus Node Dysfunction

Interventions

MRI

RADIATION

ImageReady System implant

DEVICE

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

NCT07221682

Post Operative AnalgesiaBradycardia+1 more

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RECRUITING

His Bundle Pacing in Bradycardia and Heart Failure

NCT03008291

BradycardiaHeart Failure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ImageReady(TM) MR Conditional Pacing System Clinical Study

Inclusion Criteria

Exclusion Criteria

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

His Bundle Pacing in Bradycardia and Heart Failure

Comparative Analysis Of Dexmedetomidine And Dexamethasone As An Adjuvant To 0.5%Ropivacaine On Onset Of Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries

Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution

"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery