Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDsNCT01809665
ProMRI PROVEN Master Study
An observational study of Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs, run by Biotronik SE & Co. KG at 23 sites in 8 countries.
Trial summary
This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
- What is being tested?
- ICD/CRT-P therapy and MRI
- Type of treatment
- Medical device
- How many people
- 174 participants
- Where
- 23 sitesin 8 countries
- Study dates
- Jun 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
Who may be able to join
- Written informed consent
- Able and willing to complete MRI testing
- Able and willing to activate and use the Cardio Messenger
- Able and willing to complete all testing required by the clinical protocol
- Available for all follow-up visits at the investigational site
- Standard indication for single, dual, or triple chamber ICD or CRT-P.
Show all 9Show fewer
- ICD or CRT-P system to be implanted in the pectoral region
- Patient body height ≥ 140 cm
- Age ≥ 18 years
Who cannot join
- Standard contraindication for single, dual, or triple chamber ICD or CRT-P.
- Systems with an atrial lead: The patient has persistent (lasting longer than 7 days or requiring cardioversion) or permanent atrial arrhythmia
- Patient has other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
- Patient has other metallic artifacts / components in body that may interact with MRI
- Life expectancy of less than eight months
- Cardiac surgery in the next eight months
- Pregnant or breastfeeding
- Enrolled in another non-observational cardiac clinical investigation
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
Australia6 sites
Royal Adelaide Hospital
Adelaide
Flinders Medical Center
Bedford Park, South Australia
Box Hill Hospital
Box Hill, Victoria
Royal Prince Alfred Hospital
Camperdown, New South Wales
Royal Perth Hospital
Perth
Royal North Shore Hospital
Sydney
Canada5 sites
Royal Alexandra Hospital
Edmonton
Montreal Heart Institute
Montreal, Quebec
CHUS - Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec
Sunnybrook Health Sciences Centre
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
Germany5 sites
Universitätsklinikum Bonn
Bonn, 53105
Klinikum Coburg
Coburg
Elisabeth Krankenhaus Essen
Essen, 45138
Schwarzwald Baar Klinikum Villingen Schwenningen
Villingen-Schwenningen, 78050
Medizinische Universitätsklinik Würzburg
Würzburg, 97080
About this study
Official title: Master Study for the MRI Compatibility of the Solia S and Solia T Pacing Lead, the Linoxsmart ProMRI and Linoxsmart ProMRI DF4 ICD (Implantable Cardioverter-defibrillator) Lead and the Corox ProMRI OTW Coronary Sinus Lead in Combination With the Ilesto/Iforia ICD or the Evia/Entovis Triple Chamber Pacemaker
This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.
- Being tested
- ICD/CRT-P therapy, MRI
- Keywords
- ICD therapy, CRT-P therapy, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD/CRT-P therapyDevice
Also called Ilesto 7/5, Iforia 7/5, Evia HF-T, Entovis HF-T
MRIOther
| Study group | Role | What they receive |
|---|---|---|
| ICD/CRT-P therapy | Standard indication for ICD or triple-chamber pacemaker therapy Receives: Device: ICD/CRT-P therapy; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI
Measured: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Increase in atrial and ventricular pacing threshold(s) between pre-MRI and 1-month post-MRI
Measured: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Decrease in P-wave and R-wave amplitude (right and left) between pre-MRI and 1-month post-MRI.
Measured: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang R. Bauer, Prof.Dr.Dr., Principal investigator, Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809665
- Sponsor's protocol ID
- 61
- Status last verified
- Mar 2016
- First submitted
- 12 Mar 2013
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Study for the MRI Compatibility of the Solia S and Solia T Pacing Lead, the Linoxsmart ProMRI and Linoxsmart ProMRI DF4 ICD (Implantable Cardioverter-defibrillator) Lead and the Corox ProMRI OTW Coronary Sinus Lead in Combination With the Ilesto/Iforia ICD or the Evia/Entovis Triple Chamber Pacemaker
- ClinicalTrials.gov ID
- NCT01809665
- Acronym / sponsor ID
- 61
- Keywords
- ICD therapy, CRT-P therapy, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD/CRT-P therapy | – | Device: ICD/CRT-P therapy, Other: MRIStandard indication for ICD or triple-chamber pacemaker therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.
Key inclusion criteria (9 listed)
- Written informed consent
- Able and willing to complete MRI testing
- Able and willing to activate and use the Cardio Messenger
- Able and willing to complete all testing required by the clinical protocol
- Available for all follow-up visits at the investigational site
Key exclusion criteria (8 listed)
- Standard contraindication for single, dual, or triple chamber ICD or CRT-P.
- Systems with an atrial lead: The patient has persistent (lasting longer than 7 days or requiring cardioversion) or permanent atrial arrhythmia
- Patient has other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
- Patient has other metallic artifacts / components in body that may interact with MRI
- Life expectancy of less than eight months
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 |
|---|---|---|
| ICD/CRT-P therapyAlso: Ilesto 7/5, Iforia 7/5, Evia HF-T, Entovis HF-T | Device | ICD/CRT-P therapy |
| MRI | Other | ICD/CRT-P therapy |
Primary outcome
The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI
Time frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Increase in atrial and ventricular pacing threshold(s) between pre-MRI and 1-month post-MRI
Time frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Decrease in P-wave and R-wave amplitude (right and left) between pre-MRI and 1-month post-MRI.
Time frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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.
Wolfgang R. Bauer, Prof.Dr.Dr. principal investigator
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Oberdürrbacher Str. 6, 97080 Würzburg, Germany
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs, run by Biotronik SE & Co. KG at 23 sites in 8 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 9 inclusion and 8 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 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Australia, Canada, Germany, Austria, France and 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Serious Adverse Device Effect (SADE) -free rate of the ICD/CRT-P system related to MRI (time frame: pre-MRI: approx. 2 to 5 months after implantation; post-MRI: 1 month (-2/+4 weeks) after MRI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2016.