China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD]

NCT03828357 | Completed Results

• 1 other identifier: CRD_930
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac resynchronization therapy defibrillators (CRT-Ds), with Durata or Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, and the Quartet quadripolar leads in a 1.5T MRI environment for MR-conditional labeling expansion of these market-approved ICD/CRT-D systems in China. Note: Protocol updated: Fortify Assura VR/DR ICD removed; Quadra Assura MP CRT-D and Quartet leads added. The Detailed Description Section below was updated upon protocol amendment.

Conditions

Tachycardia

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications

  Freedom from Magnetic Resonance Imaging (MRI) scan related complications related to the Implantable Cardiac Difibrillator (ICD) device and/or leads from the time of the MRI scan to 1-month post-MRI scan testing.

  1 month from MRI scan

• Effectiveness Outcomes: Percentage of Leads With a Capture Threshold Increase

  Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1-month post-MRI scan testing.

  pre-MRI scan to 1 month post-MRI scan

• The Percentage of Leads With a Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1-month Post-MRI Scan.

  Proportion of subjects with a sensing amplitude decrease ≤ 50% from pre-MRI scan to 1-month post MRI scan % (n/N)

  pre-MRI scan to 1 month post-MRI scan

Secondary Outcomes (3)

• Device Electrical Measurements

  Pre-MRI scan, Post MRI scan, 1 month follow-up

• Number of Participants With Whole Body (WB) SAR Values Measured ≥ 1.8 W/kg

  during MRI scan

• Summary of Subjects That Returned to Usual Programming

  MRI scan visit

Study Arms (4)

Ellipse VR with Durata

Ellipse VR single-chamber ICD with a Durata defibrillation lead

Other: Study MRI scan

Ellipse DR with Durata & Tendril STS

Ellipse DR dual-chamber ICD with a Durata lead in the right ventricle (RV) and a Tendril STS lead in the right atrium (RA).

Other: Study MRI scan

Ellipse DR with Optisure and Isoflex

Ellipse DR dual-chamber ICD with an Optisure defibrillation lead in the right ventricle (RV) and an Isoflex lead in the right atrium (RA).

Other: Study MRI scan

Quadra Assura MP CRT-D

Quadra Assura MP CRT-D with an Optisure or Durata defibrillation lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV

Other: Study MRI scan

Interventions

Study MRI scan OTHER

At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.

Ellipse DR with Durata & Tendril STS; Ellipse DR with Optisure and Isoflex; Ellipse VR with Durata; Quadra Assura MP CRT-D

Eligibility Criteria

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

Study Population

The study population includes male and female Chinese nationals that meet the eligibility requirements and give consent for the study. Vulnerable subjects, such as minors or those unable to provide consent are excluded from participating.

You may qualify if:

• Have an approved indication for implantation of a ICD
• Be a Chinese national
• Will be implanted with one of the following device/lead combinations evaluated in this study:
• Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle (RV)
• Group 2: Fortify Assura single-chamber ICD, with an Optisure lead
• Group 3: Ellipse DR dual-chamber ICD with a Durata lead in the RV and a Tendril STS lead in the right atrium (RA)
• Group 4: Fortify Assura ICD and an Optisure lead in the RV and an Isoflex lead in the RA
• Be willing to undergo an elective MRI scan without sedation ≥ 45 days after implant NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
• Be able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
• Be willing and able to comply with the prescribed follow-up tests and procedures
• Are not contraindicated for an MRI scan (per the MRI Screening Form)
• Subjects who are at least 18 years of age (or older, required by local law)

You may not qualify if:

• Have a competitor's MRI compatible endocardial lead implanted or capped
• Have another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
• Have other non-MRI compatible device or material implanted. The following examples may be included as long as labelling of these devices allow MRI scans conducted per this protocol:
• MRI compatible knee replacements, hip replacements, stents, etc.
• MRI compatible mechanical, prosthetic, and bio prosthetic heart valves
• Non-removable dental implants
• Have a lead extender, adaptor, or capped/abandoned lead
• Enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this study as determined by Abbott.
• Pregnant or planning to become pregnant during the duration of the subject's participation in the study
• Have a life expectancy of less than 12 months due to any condition

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Grant Kim, Director Clinical Programs
• Organization: Abbott

grant.kim1@abbott.com

8184933147

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: February 4, 2019
• Study Start: March 27, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 7, 2023
• Results First Posted: December 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)