Observation of ImageReady™ MR Conditional Defibrillation System in China

NCT03451721 | Completed Results

• 1 other identifier: C2082
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (6)

• The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free

  The primary safety endpoint of the MR ICD study will be assessed for all subjects who undergo any portion of the study-required MR scan sequences. Safety will be confirmed by evaluating the MR scan related ImageReady System complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month.MR scan related ImageReady System complication is relation with ImageReady System and MR Scan.

  MRI + 1 Month Visit（10-13 weeks from 0 day）

• The Percentage of Participant Whose the Average RV Shocking Impedance is >200 Ohm 1 Month Post Scan, While it is ≤ 200 Ohm Before Scan

  The normal RV shocking impedance measured by the system should be≤200 Ohm, with \>200 Ohm considered abnormal. The primary effectiveness endpoint 1 is defined as that the average RV shocking impedance is \>200 Ohm at 1 month post scan, while it is ≤ 200 Ohm before scan.There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 1 occur.

  MRI+1 Month visit ( 10~13 weeks from 0 day)

• The Percentage of Participant That Have an Increase in Average RV Pacing Thresholds > 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up

  Subjects that have an increase in average RV pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a primary effectiveness endpoint 2 event.The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 2 occur.

  MRI+1Month visit( 10~14 weeks from 0 day)

• The Percentage of Participant That Have the Average RV Sensed Amplitude at the MRI + 1 Month Visit Remains < 5.0 mV or Less Than 50% of the Pre-MR Scan Value

  Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary effectiveness endpoint 3 event.The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 3 occur.

  MR+1 Month visit( 10~14 weeks from 0 day)

• The Percentage of Participant Have an Increase in Average LV Pacing Thresholds >1.0V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up

  Subjects that have an increase in average LV pacing thresholds ≤1.0V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a primary effectiveness endpoint 4 event.The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 4 occur.

  MR +1 Month visit( 10~14 weeks from 0 day)

• the Percentage of Participant That Have the Average LV Sensed Amplitude at the MRI + 1 Month Visit Remains <5.0 mV or Above 50% of the Pre-MR Scan Value

  Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary effectiveness endpoint 5 event.The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 5 occur.

  MR +1 Month visit( 10~14 weeks from 0 day)

Study Arms (1)

ImageReady™ MR Conditional Defibrillation System

EXPERIMENTAL

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

Device: ImageReady™ MR Conditional Defibrillation System

Interventions

ImageReady™ MR Conditional Defibrillation System DEVICE

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

ImageReady™ MR Conditional Defibrillation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders
• 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
• Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit
• 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)
• 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
• 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
• Subjects currently requiring dialysis
• Subject has a mechanical heart valve
• Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (7)

• 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.

  PMID: 21969340 BACKGROUND

• 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.

  PMID: 28225684 BACKGROUND

• 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..

  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.

  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.

  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.

  PMID: 18547191 BACKGROUND

• 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.

  PMID: 17515363 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Yangang Su
• Organization: Zhongshan Hospital

suyangang111@163.com

+86 13788905096

Study Officials

• Yangang Su, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: March 2, 2018
• Study Start: April 3, 2018
• Primary Completion: March 12, 2019
• Study Completion: December 10, 2019
• Last Updated: November 1, 2021
• Results First Posted: April 24, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)