ENABLE MRI (Magnetic Resonance Imaging)

Magnetic Resonance Imaging Clinical Trial

— ENABLE-MRI  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652481
• Other study ID #: C1734
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 4, 2018

Study information

• Verified date: January 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 4, 2018
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. 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

2. Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region

3. Subject is able and willing to undergo an MR scan without intravenous sedation (Phase I only)

4. 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

5. Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Key Exclusion Criteria:

1. Subject implanted with an ICD or CRT-D pulse generator with battery at Explant status

2. Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders

3. 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

4. Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit (Phase I only)

5. 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 (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.

6. 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

7. 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

8. 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)

9. Subjects with an implanted lead that is planned to be extracted during the study implant procedure

10. Subjects currently requiring dialysis

11. Subject has a mechanical heart valve

12. Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)

13. Subject is currently on the active heart transplant list

14. Subject has documented life expectancy of less than 12 months

15. 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

16. 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:

1. Unstable heart failure requiring hospitalization in the last 30 calendar days

2. Unable to tolerate sedation (e.g. IV (intravenous sedation )sedation, general anesthesia)

3. Planned cardiac revascularization procedure

4. Right Ventricular Lead R wave is less than 5 mV(milliVolt)

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Device:
• ImageReady MR Conditional Defibrillation System
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

Locations

Country	Name	City	State
Belgium	Academisch Ziekenhuis Middelheim	Antwerp
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Medizinische Hochschule Hannover MHH	Hannover
Germany	Klinikum Magdeburg	Magdeburg
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Israel	Rambam Medical Center	Haifa
Israel	Soroka MC	Petah Tikva
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Hadassah Hebrew University Medical Center	Tel Hashomer
Italy	Fondazione di Ricerca e Cura 'Giovanni Paolo II'	Campobasso
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Azienda Ospedaliera San Camillo-Forlanini	Roma
Italy	Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina	Roma
Italy	Ospedale san giovanni calibita	Roma
Italy	Policlinico Casilino	Roma
Italy	Osp. S. Maria Della Misericordia	Udine
Malaysia	Institut Jantung Negara	Kuala Lumpur
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Spain	Hospital Clinic de Barcelona	Barcelona
United Kingdom	Heart and Chest Hospital	Liverpool
United Kingdom	Guys and St. Thomas NHS Foundation Trust	London
United Kingdom	Freeman Hospital	Newcastle
United States	Emory University Hospital	Atlanta	Georgia
United States	SouthEast Texas Clinical Research Center	Beaumont	Texas
United States	Manatee Memorial Hospital	Bradenton	Florida
United States	Bryn Mawr Medical Specialists	Bryn Mawr	Pennsylvania
United States	University of North Carolina Hospital	Chapel Hill	North Carolina
United States	OhioHealth Research and Innovation Institute - Riverside Methodist Hospital	Columbus	Ohio
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	St. Vincent's Hospital	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	Marquette General Hospital	Marquette	Michigan
United States	St. Thomas Research Institute, LLC	Nashville	Tennessee
United States	Northwell Health	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Huntington Memorial Hospital	Pasadena	California
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Virginia Commonwealth University Health System	Richmond	Virginia
United States	Centracare Heart and Vascular Center	Saint Cloud	Minnesota
United States	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota
United States	University of Utah Hospital and Clinics	Salt Lake City	Utah
United States	University of California - San Diego-N	San Diego	California
United States	Cox Health	Springfield	Missouri
United States	St. John's hospital	Springfield	Illinois
United States	University Community Hospital	Tampa	Florida
United States	University of Texas Houston Health Science Center	The Woodlands	Texas
United States	The Toledo Hospital	Toledo	Ohio
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Trinity Mother Frances Health System	Tyler	Texas
United States	PeaceHealth Southwest Medical	Vancouver	Washington
United States	John Muir Medical Center	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Hong Kong,  Israel,  Italy,  Malaysia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The time between the MR Scan and MRI + 1 Month
Primary	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.	The time between the MR Scan and MRI + 1 Month
Primary	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.	The time between the MR Scan and MRI + 1 Month
Primary	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.	The time between the MR Scan and MRI + 1 Month
Primary	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.	The time between the MR Scan and MRI + 1 Month