MedDataX Logo

Observation of ImageReady™ MR Conditional Defibrillation System in China

NCT ID: NCT03451721

Last Updated: 2021-11-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2019-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-center, prospective, single-arm study, aimed to observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.It will enroll 20 subjects in 5 sites in China.The primary safety endpoint is MR scan-related Complication-free rate between the MR Scan and the MRI + 1 Month Visit. The primary effectiveness endpoints include:1.Abnormal increase in RV shocking impedance from the pre-MR scan to the 1 Month post-MR scan. 2.Increase in RV pacing threshold from the pre-MR scan to the 1 Month post-MR scan. 3.Decrease in RV sensed amplitude from the pre-MR scan to the 1 Month post-MR scan. 4.Increase in LV pacing threshold from the pre-MR scan to the 1 Month post-MR scan. 5.Decrease in LV sensed amplitude from the pre-MR scan to the 1 Month post- MR scan.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arrhythmia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ImageReady™ MR Conditional Defibrillation System

1. Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology
2. Subject must have the ImageReady System as their initial (de novo) defibrillation system implant

Group Type EXPERIMENTAL

ImageReady™ MR Conditional Defibrillation System

Intervention Type DEVICE

Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ImageReady™ MR Conditional Defibrillation System

Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject is indicated to Class I/II indications per guidelines/consensus released by Chinese Society of Cardiac Pacing and Electrophysiology
2. Subject must have the ImageReady System as their initial (de novo) defibrillation system implant
3. Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD
4. Subject is able and willing to undergo an MR scan
5. Subject is willing and capable of providing 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
6. Subject is age 18 or above

Exclusion Criteria

1. Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders
2. Presence of metallic objects that represent a contraindication to MR imaging at the discretion of the Radiologist and impacting the ability to conduct the study protocol
3. Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit
4. Subject with:

* A history of syncope related to brady-arrhythmia
* A history of syncope of unknown etiology
* Sinus pauses (Pause \> 2 s)
* Permanent or intermittent complete AV block
* Documentation of progressive AV nodal block over time
* Trifascicular block (alternating bundle branch block or PR \> 200 ms with LBBB or other bifascicular block)

* Note: It is required to run a 12 lead ECG and a 10s rhythm strip to document this exclusion criterion.
5. Subject is not clinically capable of tolerating the absence of pacing or Resynchronization therapy support in a supine position for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion
6. Subject is not clinically capable of tolerating the absence of Tachycardia therapy support for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion
7. Subjects currently requiring dialysis
8. Subject has a mechanical heart valve
9. Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
10. Subject is currently on the active heart transplant list
11. Subject has documented life expectancy of less than 12 months
12. Subject is enrolled in any other concurrent study that might interfere with this study
13. Women of childbearing potential who are or might be pregnant at the time of this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yangang Su, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.

Reference Type BACKGROUND
PMID: 21969340 (View on PubMed)

Russo RJ, Costa HS, Silva PD, Anderson JL, Arshad A, Biederman RW, Boyle NG, Frabizzio JV, Birgersdotter-Green U, Higgins SL, Lampert R, Machado CE, Martin ET, Rivard AL, Rubenstein JC, Schaerf RH, Schwartz JD, Shah DJ, Tomassoni GF, Tominaga GT, Tonkin AE, Uretsky S, Wolff SD. Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med. 2017 Feb 23;376(8):755-764. doi: 10.1056/NEJMoa1603265.

Reference Type BACKGROUND
PMID: 28225684 (View on PubMed)

ASTM Standard F2503-08, "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment" ASTM International, West Conshohocken, PA, 2008, DOI: 10.1520/F2503-08, www.astm.org..

Reference Type BACKGROUND

Chinese Medical Association ECG Physiology and Pacing Branch, Chinese Medical Association Cardiology Branch, Chinese Medical Association Cardiology Professional Committee implanted cardioverter defibrillator treatment. Implanted cardioverter defibrillator treatment of China Expert consensus. Chinese Journal of Cardiac Arrhythmias 2014;18:242-53.

Reference Type BACKGROUND

Shu Zhang, Dejia Huang, Wei Hua, et al. Advice on cardiac resynchronization therapy for chronic heart failure (revised in 2013). Chinese Journal of Cardiac Arrhythmias 2013;17:247-61.

Reference Type BACKGROUND

Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, Clayton EW, Fletcher JG, Georgieff MK, Hammerschmidt D, Hudson K, Illes J, Kapur V, Keane MA, Koenig BA, Leroy BS, McFarland EG, Paradise J, Parker LS, Terry SF, Van Ness B, Wilfond BS. Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics. 2008 Summer;36(2):219-48, 211. doi: 10.1111/j.1748-720X.2008.00266.x.

Reference Type BACKGROUND
PMID: 18547191 (View on PubMed)

Kanal E, Barkovich AJ, Bell C, Borgstede JP, Bradley WG Jr, Froelich JW, Gilk T, Gimbel JR, Gosbee J, Kuhni-Kaminski E, Lester JW Jr, Nyenhuis J, Parag Y, Schaefer DJ, Sebek-Scoumis EA, Weinreb J, Zaremba LA, Wilcox P, Lucey L, Sass N; ACR Blue Ribbon Panel on MR Safety. ACR guidance document for safe MR practices: 2007. AJR Am J Roentgenol. 2007 Jun;188(6):1447-74. doi: 10.2214/AJR.06.1616. No abstract available.

Reference Type BACKGROUND
PMID: 17515363 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C2082

Identifier Type: -

Identifier Source: org_study_id