Magnetic Resonance ImagingENABLE-MRINCT02652481
ENABLE MRI (Magnetic Resonance Imaging)
A study testing ImageReady MR Conditional Defibrillation System in people with Magnetic Resonance Imaging, run by Boston Scientific Corporation at 57 sites in 9 countries.
Trial summary
The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled Conditions of Use (Phase I). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- ImageReady MR Conditional Defibrillation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 57 sitesin 9 countries
- Study dates
- Jan 2016to 4 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase I: Subject is indicated per guidelines and will receive a CRT-D or ICD system OR Subject is implanted with a functional and stable CRT-D or ICD system Phase II: Subject is implanted with a functional and stable CRT-D or ICD system
- Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region
- Subject is able and willing to undergo an MR scan without intravenous sedation (Phase I only)
- 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, or of legal age to give informed consent specific to state and national law
Who cannot join
- Subject implanted with an ICD or CRT-D pulse generator with battery at Explant status
- 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 (Phase I only)
- Subject with:
- A history of syncope related to brady-arrhythmia
Show all 28Show fewer
- A history of syncope of unknown etiology
- Sinus pauses (Pause > 2 s)
- Permanent or intermittent complete AV (Atrioventricular ) block
- Documentation of progressive AV nodal block over time
- Trifascicular block (alternating bundle branch block or PR > 200 ms (interval between P wave and R-wave) with LBBB ( Left bundle branch block) or other bifascicular block) Note: It is required to run a 12 lead ECG (Electrocardiography) and a 10s rhythm strip to document this exclusion criterion. During ECG acquisition, subjects must be in either their own intrinsic rhythm or, in subjects with an existing device implant, the device must be programmed to VVI (ventricular demand pacing) 40 ppm.
- 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 with a planned RA( right atrium), RV ( right ventricle) or LV (left ventricle) lead revision or extraction within 30 days of enrollment (Phase I only)
- Subjects with an implanted lead that is planned to be extracted during the study implant procedure
- Subjects currently requiring dialysis
- Subject has a mechanical heart valve
- Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
- Subject is currently on the active heart transplant list
- Subject has documented life expectancy of less than 12 months
- Subject is enrolled in a concurrent study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
- Women of childbearing potential who are or might be pregnant, and will receive an ICD or CRT-D pulse generator
- VF Induction Sub-study Exclusion Criteria:
- In addition to meeting all of the inclusion criteria and none of the exclusion criteria of the ENABLE MRI study, subjects enrolled in the VF Induction Sub-study must also not meet any of the following VF Induction Sub-study exclusion criteria:
- Unstable heart failure requiring hospitalization in the last 30 calendar days
- Unable to tolerate sedation (e.g. IV (intravenous sedation )sedation, general anesthesia)
- Planned cardiac revascularization procedure
- Right Ventricular Lead R wave is less than 5 mV(milliVolt)
Trial locations and contacts
57 sites in 9 countries.
57 sites in 9 countries
United States34 sites
Emory University Hospital
Atlanta, Georgia
SouthEast Texas Clinical Research Center
Beaumont, Texas
Manatee Memorial Hospital
Bradenton, Florida
Bryn Mawr Medical Specialists
Bryn Mawr, Pennsylvania
University of North Carolina Hospital
Chapel Hill, North Carolina
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio
Providence Regional Medical Center Everett
Everett, Washington
Heart Center Research, LLC
Huntsville, Alabama
St. Vincent's Hospital
Indianapolis, Indiana
University of Iowa Hospitals and Clinics
Iowa City, Iowa
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, 72653
Lakeland Regional Medical Center
Lakeland, Florida
Marquette General Hospital
Marquette, Michigan
St. Thomas Research Institute, LLC
Nashville, Tennessee
Northwell Health
New York, New York
Sentara Norfolk General Hospital
Norfolk, Virginia
Huntington Memorial Hospital
Pasadena, California
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania
Providence St. Vincent Medical Center
Portland, Oregon
Rapid City Regional Hospital
Rapid City, South Dakota
Virginia Commonwealth University Health System
Richmond, Virginia
Centracare Heart and Vascular Center
Saint Cloud, Minnesota
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota
University of Utah Hospital and Clinics
Salt Lake City, Utah
University of California - San Diego-N
San Diego, California
St. John's hospital
Springfield, Illinois
Cox Health
Springfield, Missouri
University Community Hospital
Tampa, Florida
University of Texas Houston Health Science Center
The Woodlands, Texas
The Toledo Hospital
Toledo, Ohio
North Mississippi Medical Center
Tupelo, Mississippi
Trinity Mother Frances Health System
Tyler, Texas
PeaceHealth Southwest Medical
Vancouver, Washington
John Muir Medical Center
Walnut Creek, California
Italy7 sites
Fondazione di Ricerca e Cura 'Giovanni Paolo II'
Campobasso
Azienda Ospedaliera Universitaria Federico II
Naples
Azienda Ospedaliera San Camillo-Forlanini
Roma
Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
Roma
Ospedale san giovanni calibita
Roma
Policlinico Casilino
Roma
Osp. S. Maria Della Misericordia
Udine
Israel4 sites
Rambam Medical Center
Haifa
Soroka MC
Petah Tikva
Tel Aviv Sourasky Medical Center
Tel Aviv
Hadassah Hebrew University Medical Center
Tel Litwinsky
Germany3 sites
Deutsches Herzzentrum Berlin
Berlin
Medizinische Hochschule Hannover MHH
Hanover
Klinikum Magdeburg
Magdeburg
United Kingdom3 sites
Heart and Chest Hospital
Liverpool
Guys and St. Thomas NHS Foundation Trust
London
Freeman Hospital
Newcastle
Hong Kong2 sites
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Malaysia2 sites
Institut Jantung Negara
Kuala Lumpur
University of Malaya Medical Centre
Kuala Lumpur
About this study
Official title: Expanding MRI (Magnetic Resonance Imaging) Access for Patients With New and Existing ICDs (Implantable Cardioverter Defibrillator) and CRT-Ds (Cardiac Resynchronization Therapy Defibrillator)
The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled Conditions of Use (Phase I).
Additionally, the study will assess medically necessary MR scans according to the labeled Conditions of Use to provide real-world scanning data (Phase I and Phase II).The study also aims to demonstrate the continued ability of the ImageReady MR Conditional Defibrillation System to sense and detect ventricular fibrillation (VF) post MRI scan by collecting and analyzing data from spontaneous VF episodes, "for-cause" VF inductions, and from an optional VF induction Sub-study.
.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- ImageReady MR Conditional Defibrillation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImageReady MR Conditional Defibrillation SystemDevice
ImageReady MR Conditional Defibrillation System Components:
Device Name Device Model Number Pulse Generators Phase I and II Phase II Only * CRT-D (IS1/DF4/IS4) VR ICD (DF4) DR ( dual chamber) ICD (IS1/DF4) ORIGEN™ MINI ICD ORIGEN EL ICD ORIGEN X4 CRT INOGEN™ MINI ICD INOGEN EL ICD INOGEN X4 CRT DYNAGEN™ MINI ICD DYNAGEN EL ICD DYNAGEN X4 CRT-D AUTOGEN ™ MINI ICD* AUTOGEN EL ICD* AUTOGEN X4 CRT-D* Right Atrial Leads and Accessories FINELINE™ II Sterox FINELINE II Sterox EZ Suture Sleeves for FINELINE II Leads INGEVITY™ MRI* Suture Sleeve for INGEVITY MRI* IS-1 Lead Port Plug 7145 Right Ventricular Leads and Accessories RELIANCE 4-FRONT™ (DF4)* Suture Sleeve for RELIANCE 4-FRONT leads*; ENDOTAK RELIANCE™ (DF4) Left Ventricular Leads and Accessories ACUITY™ X4 (IS4) Suture Sleeve for ACUITY X4 leads
- May only be used internationally outside the US
| Study group | Role | What they receive |
|---|---|---|
| ImageReady MR Conditional Defibrillation System Group | Other | Prospective, non-randomized, confirmatory study.Subjects will initially be enrolled into Phase I to undergo a non-diagnostic study required MR Scan. Once Phase I is complete, subjects will be enrolled into Phase II where there is no requirement to undergo a non-diagnostic study required MR scan Up to 37 subjects will be used for an interim analysis. Of these subjects, the first 20 who undergo the study required MRI scan and complete the MRI + 1 Month Visit will be used for this analysis. The second cohort will consist of subjects who will receive the non-diagnostic study required MR scan until 137 CRT-D and 28 VR ( single chamber) ICD subjects undergo the study required MR scan (complete or incomplete).
De novo implants and existing implants may be enrolled in Phase I There will be a non-diagnostic study required MR scan (during the MRI visit) There will be a study required MRI visit and MRI + 1 month visit Receives: Device: ImageReady MR Conditional Defibrillation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications
MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit
Measured: The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV
Increases in RV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in average pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up were considered a success.
Measured: The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms.
Increases in average LV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in pacing thresholds measurements ≤ 1.0V (at 0.5 ms) from pre-MR Scan at MRI Visit to MRI + 1 Month Visit were considered a success.
Measured: The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude
Decreases in RV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were 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. Subjects who had an average pre-scan RV sensed amplitude measurement < 5.0 mV were excluded from this analysis.
Measured: The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude
Decreases in average LV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remained ≥ 5.0 mV and above 50% of the average pre-MR scan value. Subjects who had an average pre-scan LV sensed amplitude measurement < 5.0 mV were excluded from this analysis.
Measured: The time between the MR Scan and MRI + 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion30 Apr 2017
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Voss, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652481
- Sponsor's protocol ID
- C1734
- Acronym
- ENABLE-MRI
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2016
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rinaldi CA, Vitoff PJ, Nair DG, Bernstein R, Mountantonakis SE, Rapacciuolo A, Carter N, Tse HF, Green UB. Safety of magnetic resonance imaging scanning in patients with cardiac resynchronization therapy-defibrillators incorporating quadripolar left ventricular leads. Heart Rhythm. 2020 Dec;17(12):2064-2071. doi: 10.1016/j.hrthm.2020.08.020. Epub 2020 Sep 7.
PubMed 32911050
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding MRI (Magnetic Resonance Imaging) Access for Patients With New and Existing ICDs (Implantable Cardioverter Defibrillator) and CRT-Ds (Cardiac Resynchronization Therapy Defibrillator)
- ClinicalTrials.gov ID
- NCT02652481
- Acronym / sponsor ID
- ENABLE-MRI / C1734
- Conditions
- Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled Conditions of Use (Phase I).
Additionally, the study will assess medically necessary MR scans according to the labeled Conditions of Use to provide real-world scanning data (Phase I and Phase II).The study also aims to demonstrate the continued ability of the ImageReady MR Conditional Defibrillation System to sense and detect ventricular fibrillation (VF) post MRI scan by collecting and analyzing data from spontaneous VF episodes, "for-cause" VF inductions, and from an optional VF induction Sub-study.
.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ImageReady MR Conditional Defibrillation System Group | Other | Device: ImageReady MR Conditional Defibrillation SystemProspective, non-randomized, confirmatory study.Subjects will initially be enrolled into Phase I to undergo a non-diagnostic study required MR Scan. Once Phase I is complete, subjects will be enrolled into Phase II where there is no requirement to undergo a non-diagnostic study required MR scan Up to 37 subjects will be used for an interim analysis. Of these subjects, the first 20 who undergo the study required MRI scan and complete the MRI + 1 Month Visit will be used for this analysis. The second cohort will consist of subjects who will receive the non-diagnostic study required MR scan until 137 CRT-D and 28 VR ( single chamber) ICD subjects undergo the study required MR scan (complete or incomplete). De novo implants and existing implants may be enrolled in Phase I There will be a non-diagnostic study required MR scan (during the MRI visit) There will be a study required MRI visit and MRI + 1 month visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Phase I: Subject is indicated per guidelines and will receive a CRT-D or ICD system OR Subject is implanted with a functional and stable CRT-D or ICD system Phase II: Subject is implanted with a functional and stable CRT-D or ICD system
- Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region
- Subject is able and willing to undergo an MR scan without intravenous sedation (Phase I only)
- 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, or of legal age to give informed consent specific to state and national law
Key exclusion criteria (28 listed)
- Subject implanted with an ICD or CRT-D pulse generator with battery at Explant status
- 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 (Phase I only)
- Subject with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImageReady MR Conditional Defibrillation SystemImageReady MR Conditional Defibrillation System Components: Device Name Device Model Number Pulse Generators Phase I and II Phase II Only * CRT-D (IS1/DF4/IS4) VR ICD (DF4) DR ( dual chamber) ICD (IS1/DF4) ORIGEN™ MINI ICD ORIGEN EL ICD ORIGEN X4 CRT INOGEN™ MINI ICD INOGEN EL ICD INOGEN X4 CRT DYNAGEN™ MINI ICD DYNAGEN EL ICD DYNAGEN X4 CRT-D AUTOGEN ™ MINI ICD* AUTOGEN EL ICD* AUTOGEN X4 CRT-D* Right Atrial Leads and Accessories FINELINE™ II Sterox FINELINE II Sterox EZ Suture Sleeves for FINELINE II Leads INGEVITY™ MRI* Suture Sleeve for INGEVITY MRI* IS-1 Lead Port Plug 7145 Right Ventricular Leads and Accessories RELIANCE 4-FRONT™ (DF4)* Suture Sleeve for RELIANCE 4-FRONT leads*; ENDOTAK RELIANCE™ (DF4) Left Ventricular Leads and Accessories ACUITY™ X4 (IS4) Suture Sleeve for ACUITY X4 leads * May only be used internationally outside the US | Device | ImageReady MR Conditional Defibrillation System Group |
Primary outcome
Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications
Time frame: The time between the MR Scan and MRI + 1 Month
MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit
Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV
Time frame: The time between the MR Scan and MRI + 1 Month
Increases in RV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in average pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up were considered a success.
Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms.
Time frame: The time between the MR Scan and MRI + 1 Month
Increases in average LV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in pacing thresholds measurements ≤ 1.0V (at 0.5 ms) from pre-MR Scan at MRI Visit to MRI + 1 Month Visit were considered a success.
Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude
Time frame: The time between the MR Scan and MRI + 1 Month
Decreases in RV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were 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. Subjects who had an average pre-scan RV sensed amplitude measurement < 5.0 mV were excluded from this analysis.
Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude
Time frame: The time between the MR Scan and MRI + 1 Month
Decreases in average LV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remained ≥ 5.0 mV and above 50% of the average pre-MR scan value. Subjects who had an average pre-scan LV sensed amplitude measurement < 5.0 mV were excluded from this analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32911050Rinaldi CA, Vitoff PJ, Nair DG, Bernstein R, Mountantonakis SE, Rapacciuolo A, Carter N, Tse HF, Green UB. Safety of magnetic resonance imaging scanning in patients with cardiac resynchronization therapy-defibrillators incorporating quadripolar left ventricular leads. Heart Rhythm. 2020 Dec;17(12):2064-2071. doi: 10.1016/j.hrthm.2020.08.020. Epub 2020 Sep 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Voss study director
Boston Scientific Corporation
57 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ImageReady MR Conditional Defibrillation System in people with Magnetic Resonance Imaging, run by Boston Scientific Corporation at 57 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Italy, Israel, Germany, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications (time frame: The time between the MR Scan and MRI + 1 Month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02652481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.