Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03828357 |
| Other study ID # |
CRD_930 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 27, 2019 |
| Est. completion date |
December 1, 2020 |
Study information
| Verified date |
March 2023 |
| Source |
Abbott Medical Devices |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Endpoints, and contents of clinical study
Objectives:
The objective of 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.
There are four device combination groups in this clinical study as outlined below:
- Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle (RV).
- Group 2: Ellipse DR dual-chamber ICD, with a Durata lead in the RV and a Tendril STS
lead in the right atrium (RA).
- Group 3: Ellipse DR dual-chamber ICD with a Optisure lead in the RV and a Isoflex lead
in the RA.
- Group 4: Quadra Assura MP CRT-D with a Durata or Optisure lead in the RV, a Tendril STS
or Isoflex lead in the RA, and a Quartet lead in the left ventricle (LV).
Endpoints
Primary Endpoints
- Safety: Freedom from MRI-scan related complications related to the ICD device and/or
leads from the time of the MRI scan to 1-month post-MRI scan testing.
- Effectiveness: Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms
for RA and RV leads and ≤1.0V at 0.5ms for LV leads from pre-MRI scan to 1-month
post-MRI scan testing.
- Effectiveness: Proportion of leads with a sensing amplitude decrease of ≤ 50% from
pre-MRI scan testing to 1-month post-MRI scan.
Descriptive Endpoint(s)
Descriptive endpoints are reported using only summary statistics and no hypothesis tests will
be performed.
The following data will be collected:
1. Demographics: gender, age, ethnicity, race, cardiac disease history, arrhythmia history,
indication for ICD implant, history of smoking, etc.
2. Device electrical measurements at the MRI Scan Visit (pre- and post-scan) and at the 1
Month Post Scan Visit
3. ADE, SADE, USADE
4. Mortality
5. Number of non-study MRI scans
6. Summarize number of subjects that returned to usual programming after the MRI scan and
number of subjects, if any, experiencing delays in reprogramming
This is a prospective, multi-center, single-arm study to evaluate the safety and
effectiveness of the Ellipse VR/DR ICDs, and the Quadra Assura MP CRT-D, with Durata or
Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, and the Quartet
quadripolar LV lead in a 1.5T MRI environment for MR-conditional labeling expansion in China.
This study will be conducted in at least 6 centers in China and at least 60 subjects who
provide consent for participation will be enrolled. Subjects will be considered enrolled
after providing consent. Subjects will be implanted with any one of the device/lead
combination groups outlined in Figure 1, depending on their clinical need as determined by
the Investigators. At least 15 subjects will be enrolled in each group.
- Group 1 will have at least 15 enrolled subjects with the Ellipse VR single-chamber ICD
with a Durata lead in the RV.
- Group 2 will have at least 15 enrolled subjects with the Ellipse DR dual-chamber ICD
with a Durata lead in the RV and a Tendril STS lead in the RA.
- Group 3 will have at least 15 enrolled subjects with the Ellipse DR dual-chamber ICD
with a Optisure lead in the RV and a Isoflex lead in the RA.
- Group 4 will have at least 15 enrolled subjects with a Quadra Assura MP CRT-D and an
Optisure or Durata lead in the RV, an Isoflex or Tendril STS lead in the RA, and a
Quartet lead in the LV.
The enrollment group and group 4 lead pairing will be at the discretion of the Investigator,
dependent on patient needs in conjunction with study needs to fulfill study goals.
At least forty-five (45) days after system implantation or after a system revision, subjects
will have a baseline visit followed by an MRI visit; subjects will undergo a study-related
MRI scan at 1.5T. Subjects will have a 1-month follow-up after the study MRI scan. The
minimum duration of each subject's participation is approximately 2.5 months from enrollment.
The expected duration of enrollment is approximately 14 months. The total duration of
clinical study is expected to be 16.5 months.
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.
Inclusion criteria
Assessment for general eligibility criteria is based on medical records of the site and
interview with a candidate patient. If some of the clinical and laboratory tests are not
included in site standard tests, they must be done but after written informed consent is
obtained. Patients must meet ALL the inclusion criteria to be considered for the clinical
study. If ANY of the exclusion criteria are met, the patient is excluded from the clinical
study and cannot be enrolled.
To participate in this clinical study, the subject must meet all the following inclusion
criteria:
- Have an approved indication for implantation of an ICD, or CRT-D
- 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 RV
- Group 2: Ellipse DR dual-chamber ICD, with a Durata lead in the RV and a Tendril
STS lead in the RA
- Group 3: Ellipse DR dual-chamber ICD with a Optisure lead in the RV and a Isoflex
lead in the RA
- Group 4: Quadra Assura MP CRT-D and an Optisure or Durata lead in the RV, an
Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV
- 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)
Exclusion criteria
Subjects who meet any of the following exclusion criteria must be excluded from the clinical
investigation:
- 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
Effectiveness evaluation method
There are two effectiveness endpoints to be evaluated in this study.
1. Description of the effectiveness endpoints
- Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms for RA and
RV leads and ≤ 1.0V at 0.5ms for LV leads from pre-MRI scan to 1-month post-MRI
scan testing.
- Proportion leads with a sensing amplitude decrease of ≤ 50% from pre-MRI scan
testing to 1-month post-MRI scan.
2. Selection of method and time for evaluation, recording and analysis of the effectiveness
endpoints Since the objective is to evaluate the effect of MRI exposure for the ICD/
CRT-D device groups included in this study, the effectiveness parameters were selected
to compare abnormal changes in device performance from pre- to 1-month post- MRI scan.
The pre-MRI measurements are collected within the same day prior to the MRI scan. The
1-month post-MRI scan measurements are collected at 30 days post-MRI scan (within +14
days) to ensure any effect of the MRI exposure is captured.
The effectiveness parameters are recorded directly from the device. The device measurements
will be obtained using the Merlin programmer to interrogate the device during study visits.
The analysis of the effectiveness parameters will be conducted on all subjects with complete
data from pre- to 1-month post-MRI scan.
Safety evaluation method There is one safety primary endpoint to be evaluated in this study.
1. Description of the safety endpoint Freedom from MRI-scan related complications from the
time of the MRI scan to 1-month post-MRI scan testing.
2. Selection of method and time for evaluation, recording and analysis of the safety
endpoints Since the objective is to evaluate the effect of MRI exposure for the ICD/
CRT-D device groups included in this study, the safety parameters were selected to
include only MRI-scan related complications from the time of device programming for an
MRI scan to 1-month post-MRI scan. An independent physician CEC will adjudicate all
adverse device effects during this period to determine the relatedness to the MRI scan.
Safety surveillance within this study and the safety reporting, both performed by the
investigator, starts as soon as the subject completes the pre-MRI visit testing and the MRI
Settings have been programmed according to the protocol. The safety surveillance and the
safety reporting will continue until the last study visit has been performed, the subject is
deceased, the subject/investigator concludes his participation into the clinical study or the
subject withdrawal from the clinical study.
Monitoring plan
Sponsor and/or designee will monitor the clinical study over its duration according to the
CIP-specific monitoring plan which will include the planned extent of source data
verification.
Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the
following criteria are met:
- The investigator understands and accepts the obligation to conduct the clinical study
according to the CIP and applicable regulations, and has signed the Clinical Trial
Agreement.
- The Investigator and his/her staff should have sufficient time and facilities to conduct
the clinical study and should have access to an adequate number of appropriate subjects
to conduct the clinical study.
- Source documentation (including original medical records) must be available to
substantiate proper informed consent procedures, adherence to CIP procedures, adequate
reporting and follow-up of adverse events, accuracy of data collected on case report
forms, and device information.
- The Investigator/site will permit access to such records. A monitoring visit sign-in log
will be maintained at the site. The Investigator will agree to dedicate an adequate
amount of time to the monitoring process. The Investigator and/or research coordinator
will be available for monitoring visits. It is expected that the Investigator will
provide the monitor with a suitable working environment for review of clinical
study-related documents.
Statistical considerations
This study is an observational study to meet the requirements for device approval by the
National Medical Products Administration (NMPA, previously China FDA). There is no endpoint
hypotheses testing planned in this study. The endpoints, demographics, safety and device data
will be summarized using descriptive statistics as outlined in the Statistical Analysis Plan
(SAP).
Any major changes to the SAP will be documented in an amendment to the SAP. Less significant
changes to the planned analyses will be documented in the final report(s).
Data management
Study data will be handled according to China Device GCP (Order 25). The Leading PI and
his/her associated organization (leading Unit) will be responsible for compiling and
submitting all required reports to governmental agencies.
Before the submission, Leading PI and his/her associated organization (leading Unit) should
allow sponsor to have a copy of the above reports for reviewing, and providing comments for
Leading PI and his/her associated organization consideration.
Data will be analyzed by the Leading PI and his/her associated organization (leading Unit)
and/or its affiliates. The Leading PI and his/her associated organization (leading Unit)'s
also agree that data may be transferred to the Sponsor's locations worldwide and/or any other
worldwide regulatory authority in support of a market-approval application.
