NCT03828357 (CN_MRI_ICD) is a clinical trial of Study MRI scan in Tachycardia, sponsored by Abbott Medical Devices.

Who is sponsoring NCT03828357?

NCT03828357 is sponsored by Abbott Medical Devices.

What drugs are being tested in NCT03828357?

Interventions in NCT03828357: Study MRI scan.

What condition does NCT03828357 study?

NCT03828357 studies Tachycardia.

Is NCT03828357 still recruiting?

NCT03828357 is currently completed. Last updated 7 December 2023.

Are results published for NCT03828357?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-12-07 · How we verify

NCT03828357: CN_MRI_ICD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Results posted Last updated 7 December 2023

What this trial tests

trial testing Study MRI scan in Tachycardia in 60 participants. Completed in 1 December 2020.

Timeline

27 March 2019

Primary endpoint
1 December 2020

1 December 2020

Quick facts

Lead sponsor	Abbott Medical Devices
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	27 March 2019
Primary completion	1 December 2020
Estimated completion	1 December 2020
Sites	1 location across China

Drugs / interventions tested

Study MRI scan

Conditions studied

Tachycardia — all drugs for Tachycardia →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Tachycardia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications Primary · 1 month from MRI scan

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.

Group	Value	95% CI
Ellipse VR With Durata	14
Ellipse DR With Durata & Tendril STS	14
Ellipse DR With Optisure and Isoflex	15
Quadra Assura MP CRT-D	12

Effectiveness Outcomes: Percentage of Leads With a Capture Threshold Increase Primary · pre-MRI scan to 1 month post-MRI scan

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.

Right Atrial (RA) leads

Group	Value	95% CI
Ellipse VR With Durata	NA
Ellipse DR With Durata & Tendril STS	100
Ellipse DR With Optisure and Isoflex	100
Quadra Assura MP CRT-D	100

Right Ventricular (RV) leads

Group	Value	95% CI
Ellipse VR With Durata	100
Ellipse DR With Durata & Tendril STS	100
Ellipse DR With Optisure and Isoflex	100
Quadra Assura MP CRT-D	100

Left Ventricular (LV) leads

Group	Value	95% CI
Ellipse VR With Durata	NA
Ellipse DR With Durata & Tendril STS	NA
Ellipse DR With Optisure and Isoflex	NA
Quadra Assura MP CRT-D	100

The Percentage of Leads With a Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1-month Post-MRI Scan. Primary · pre-MRI scan 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)

Right Atrial Leads

Group	Value	95% CI
Ellipse VR With Durata	NA
Ellipse DR With Durata & Tendril STS	100
Ellipse DR With Optisure and Isoflex	100
Quadra Assura MP CRT-D	92

Right Ventricular Leads

Group	Value	95% CI
Ellipse VR With Durata	100
Ellipse DR With Durata & Tendril STS	100
Ellipse DR With Optisure and Isoflex	100
Quadra Assura MP CRT-D	100

Device Electrical Measurements Secondary · Pre-MRI scan, Post MRI scan, 1 month follow-up

Summaries of electrical measurements taken in the Analysis Cohort at Pre-MRI scan, Post-MRI scan, and 1-month post MRI scan. The stable electrical measurements from pre-MRI scan to post-MRI scan and 1-month post MRI scan indicate that the MRI scan did not impact the electrical performance of the Ellipse ICD or Quadra Assura CRT-D system

pre-MRI: Right ventricular capture threshold

Group	Value	95% CI
Ellipse VR With Durata	0.72	± 0.19
Ellipse DR With Durata & Tendril STS	0.75	± 0.24
Ellipse DR With Optisure and Isoflex	0.80	± 0.19
Quadra Assura MP CRT-D	0.7	± 0.22

pre-MRI: Right ventricular sensing amplitude

Group	Value	95% CI
Ellipse VR With Durata	0.0113	± 0.0015
Ellipse DR With Durata & Tendril STS	0.0110	± 0.0021
Ellipse DR With Optisure and Isoflex	0.0108	± 0.0019
Quadra Assura MP CRT-D	0.0119	± 0.2

post-MRI: Right ventricular capture threshold

Group	Value	95% CI
Ellipse VR With Durata	0.71	± 0.19
Ellipse DR With Durata & Tendril STS	0.75	± 0.20
Ellipse DR With Optisure and Isoflex	0.73	± 0.18
Quadra Assura MP CRT-D	0.63	± 0.17

post-MRI: Right ventricular sensing amplitude

Group	Value	95% CI
Ellipse VR With Durata	0.0112	± 0.0017
Ellipse DR With Durata & Tendril STS	0.0113	± 0.0022
Ellipse DR With Optisure and Isoflex	0.0108	± 0.0017
Quadra Assura MP CRT-D	0.0117	± 0.0008

1 month follow-up: Right ventricular capture threshold

Group	Value	95% CI
Ellipse VR With Durata	0.73	± 0.18
Ellipse DR With Durata & Tendril STS	0.73	± 0.18
Ellipse DR With Optisure and Isoflex	0.80	± 0.2
Quadra Assura MP CRT-D	0.63	± 0.2

1 month follow-up: Right ventricular sensing amplitude

Group	Value	95% CI
Ellipse VR With Durata	0.0114	± 0.0014
Ellipse DR With Durata & Tendril STS	0.0109	± 0.0026
Ellipse DR With Optisure and Isoflex	0.0112	± 0.0013
Quadra Assura MP CRT-D	0.0117	± 0.0007

Number of Participants With Whole Body (WB) SAR Values Measured ≥ 1.8 W/kg Secondary · during MRI scan

Whole body (WB) SAR values from the RF intensive MRI scans. Abbott is seeking MR-conditional labeling for MRI scans in Normal Operating Mode (WB Specific Absorption Rate (SAR) up to 2 W/kg). Achieving a WB SAR of exactly 2 W/kg is not feasible since the MR technologist must adjust multiple interdependent scab parameters to increase the WB SAR. Therefore, an acceptable limit of ≥ 1.8 W/kg (within 10%) was established as part of the MRI scan sequence guideline document for this study prior to site enrollments to account for expected user variability.

Group	Value	95% CI
Ellipse VR With Durata	14
Ellipse DR With Durata & Tendril STS	13
Ellipse DR With Optisure and Isoflex	13
Quadra Assura MP CRT-D	12

Summary of Subjects That Returned to Usual Programming Secondary · MRI scan visit

Subjects that returned to usual programming after the MRI scan and the number of subjects experiencing delays in disabling MRI settings after the MRI scan

Group	Value	95% CI
Ellipse VR With Durata	14
Ellipse DR With Durata & Tendril STS	14
Ellipse DR With Optisure and Isoflex	15
Quadra Assura MP CRT-D	12
Ellipse VR With Durata	0
Ellipse DR With Durata & Tendril STS	0
Ellipse DR With Optisure and Isoflex	0
Quadra Assura MP CRT-D	0

Adverse events — posted to ClinicalTrials.gov

Time frame: from the period between device programming of MRI settings to 1-month post-MRI scan, as defined in the protocol.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ellipse VR With Durata

Serious: 2/14 (14%)

Deaths: 0/14

Ellipse DR With Durata & Tendril STS

Serious: 3/14 (21%)

Deaths: 0/14

Ellipse DR With Optisure and Isoflex

Serious: 2/15 (13%)

Deaths: 0/15

Quadra Assura MP CRT-D

Serious: 1/12 (8%)

Deaths: 0/12

Serious adverse events (7 terms)

Reaction	System	Ellipse VR With Durata	Ellipse DR With Durata & T…	Ellipse DR With Optisure a…	Quadra Assura MP CRT-D
OTHER: CERVICAL SPONDYLOSIS	Musculoskeletal and connective tissue disorders	—	—	—	—
OTHER:HEART FAILURE	Cardiac disorders	—	—	—	—
OTHER:Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—
OTHER: CAROTID SCLEROSIS	Cardiac disorders	—	—	—	—
OTHER: HYPERKALEMIA	Renal and urinary disorders	—	—	—	—
OTHER: DILATED CARDIOMYOPATHY	Cardiac disorders	—	—	—	—
OTHER:INAPPROPIATE SHOCK	Product Issues	—	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Ellipse VR With Durata	Ellipse DR With Durata & T…	Ellipse DR With Optisure a…	Quadra Assura MP CRT-D
OTHER: VENTRICULAR FIBRILLATION	Cardiac disorders	—	—	—	—

Most-reported serious reactions: OTHER: CERVICAL SPONDYLOSIS, OTHER:HEART FAILURE, OTHER:Chronic obstructive pulmonary disease, OTHER: CAROTID SCLEROSIS, OTHER: HYPERKALEMIA, OTHER: DILATED CARDIOMYOPATHY, OTHER:INAPPROPIATE SHOCK.

Data from ClinicalTrials.gov NCT03828357 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Tachycardia

Currently open trials in the same condition.

NCT07018648 — Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System · NA · recruiting
NCT06637904 — TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections · NA · recruiting
NCT06892938 — Detection and Classification of Cardiac Rhythm and Atrial Fibrillation Using a Finger-worn Ring · active not recruiting
NCT06048731 — Enlighten Study: The EV-ICD Post Approval Registry · active not recruiting
NCT06505668 — Effect of Atenolol Versus Ivabradine on HRV in TRS Patients on Clozapine With Tachycardia: A Randomised Control Trial. · NA · recruiting

Other Abbott Medical Devices trials

Trials by the same sponsor.

NCT07421076 — Grid eXplore Mapping Study · NA · recruiting
NCT07509658 — TriClip Japan Post-Approval Study · recruiting
NCT07361445 — Agilis RF TSP Early Feasibility Study · NA · recruiting
NCT07373353 — A Clinical Evaluation of AMJ-401 · NA · recruiting
NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03828357 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
Last refreshed: 7 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03828357.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing