Cardiac DiseaseProMRIAFFIRMNCT01460992
ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads
An observational study of Cardiac Disease, run by Biotronik SE & Co. KG at 9 sites in 5 countries.
Trial summary
This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Mar 2012to Nov 2013
- 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
- Pacemaker system consisting solely of the EVIA/ENTOVIS pacemaker and Safio S pacemaker leads
- The pacemaker system has to be implanted, repositioned or exchanged at least 5 weeks prior to enrollment
- Age more than 18 years
- Understand the nature of the procedure
- Able and willing to complete MRI testing
- Able and willing to activate and use the Cardio Messenger
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- Give written informed consent
- Able to complete all testing required by the clinical protocol
- Ability to measure atrial and/or ventricular pacing threshold(s)* (at 0.4 ms)
- All pacing thresholds do not exceed 2.0V @0.4ms.
- Available for follow-up visit at the investigational site
- Patient body height greater or equal to 140 cm
- Pectoral implantation
- The ascertained lead impedance is between 200 and 1500 Ohms.
Who cannot join
- No EVIA/ENTOVIS /Safio S pacemaker system implanted
- Pacing threshold(s) (at 0.4 ms) and sensing amplitudes are not measurable
- Meet one or more of the contraindications
- Being pregnant
- Have a life expectancy of less than three months
- Cardiac surgery already scheduled in the next three months
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- Enrolled in another cardiac clinical investigation
- Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, other active medical devices, non-MRI compatible devices (e.g. mechanical tricuspid valve)
- Have other metallic artifacts/components in body that may interact with MRI
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Germany5 sites
St. Gertrauden Krankenhaus
Berlin
Städtisches Klinikum Dresden-Friedrichstadt
Dresden
Uniklinik Leipzig
Leipzig
Diakoniekrankenhaus Mannheim
Mannheim
DRK Krankenhaus Neuwied
Neuwied
United Kingdom1 site
Cardiology Department, St Thomas' Hospital
London, SE1 7EH
About this study
Official title: Master Study for the MRI Compatibility of the EVIA/ENTOVIS Pacemaker in Combination With Safio S Pacemaker Lead
This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.
Read the detailed description
In the past, MR scans were always contraindicated for pacemaker patients. If particular prerequisites and conditions are fulfilled, MR scans can now be conducted on patients with BIOTRONIK's EVIA/ENTOVIS pacemakers in combination with the Safio S pacemaker leads, scheduled to be part of this clinical study.
The specific MRI conditions for this investigation with the EVIA/ENTOVIS pacemaker family and Safio S pacemaker leads are defined in the study protocol
- Conditions
- Cardiac Disease
- Being tested
- Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions
- Keywords
- Pacemaker therapy, Magnetic Resonance Imaging (MRI), EVIA/ENTOVIS
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditionsProcedure or surgery
Also called Evia/Entovis SR-T (single chamber with telemetry function), DR-T (dual chamber with telemetry function), Atrial/ventricular lead(s): Safio S 53 and S 60., Safio S 45
patients will undergo an MRI scan for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker therapy | Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria. Receives: Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate
MRI and pacing system related Serious Adverse Device Effect (SADE) Free-Rate is greater than 90%.
Measured: 3 months
Primary hypotheses 2 and 3: pacing threshold rise (atrial and ventricular)
The atrial or ventricular MRI induced pacing threshold rise is not larger than or equal to 0.5 V between Pre-MRI and 1-month follow-up
Measured: 1 month
Primary hypothesis 4: P-wave sensing attenuation
P-wave attenuation: P-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a P-wave amplitude at 1-month follow-up smaller or equal to 1.5 mV
Measured: 1 month
Primary hypothesis 5: R-wave sensing attenuation
R-wave attenuation: R-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a R-wave amplitude at 1-month follow-up smaller or equal to 5.0 mV.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aldo Rinaldi, Dr., Principal investigator, Cardiology Department, St Thomas' Hospital Lambeth Palace Road London, SE1 7EH United Kingdom E-mail: Aldo.Rinaldi@gstt.nhs.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460992
- Sponsor's protocol ID
- 49
- Acronym
- ProMRIAFFIRM
- Status last verified
- Nov 2013
- First submitted
- 24 Oct 2011
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bailey WM, Rosenthal L, Fananapazir L, Gleva M, Mazur A, Rinaldi CA, Kypta A, Merkely B, Woodard PK; ProMRI/ProMRI AFFIRM Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Jun;12(6):1183-91. doi: 10.1016/j.hrthm.2015.02.010. Epub 2015 Feb 11.
PubMed 25680307
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Study for the MRI Compatibility of the EVIA/ENTOVIS Pacemaker in Combination With Safio S Pacemaker Lead
- ClinicalTrials.gov ID
- NCT01460992
- Acronym / sponsor ID
- ProMRIAFFIRM / 49
- Conditions
- Cardiac Disease
- Keywords
- Pacemaker therapy, Magnetic Resonance Imaging (MRI), EVIA/ENTOVIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Oct 2011 (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 demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.
Detailed description
In the past, MR scans were always contraindicated for pacemaker patients. If particular prerequisites and conditions are fulfilled, MR scans can now be conducted on patients with BIOTRONIK's EVIA/ENTOVIS pacemakers in combination with the Safio S pacemaker leads, scheduled to be part of this clinical study.
The specific MRI conditions for this investigation with the EVIA/ENTOVIS pacemaker family and Safio S pacemaker leads are defined in the study protocol
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker therapy | – | Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditionsPatients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria. |
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 (14 listed)
- Pacemaker system consisting solely of the EVIA/ENTOVIS pacemaker and Safio S pacemaker leads
- The pacemaker system has to be implanted, repositioned or exchanged at least 5 weeks prior to enrollment
- Age more than 18 years
- Understand the nature of the procedure
- Able and willing to complete MRI testing
Key exclusion criteria (9 listed)
- No EVIA/ENTOVIS /Safio S pacemaker system implanted
- Pacing threshold(s) (at 0.4 ms) and sensing amplitudes are not measurable
- Meet one or more of the contraindications
- Being pregnant
- Have a life expectancy of less than three 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 |
|---|---|---|
| Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditionsAlso: Evia/Entovis SR-T (single chamber with telemetry function), DR-T (dual chamber with telemetry function), Atrial/ventricular lead(s): Safio S 53 and S 60., Safio S 45patients will undergo an MRI scan for 30 minutes. | Procedure or surgery | Pacemaker therapy |
Primary outcome
Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate
Time frame: 3 months
MRI and pacing system related Serious Adverse Device Effect (SADE) Free-Rate is greater than 90%.
Primary hypotheses 2 and 3: pacing threshold rise (atrial and ventricular)
Time frame: 1 month
The atrial or ventricular MRI induced pacing threshold rise is not larger than or equal to 0.5 V between Pre-MRI and 1-month follow-up
Primary hypothesis 4: P-wave sensing attenuation
Time frame: 1 month
P-wave attenuation: P-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a P-wave amplitude at 1-month follow-up smaller or equal to 1.5 mV
Primary hypothesis 5: R-wave sensing attenuation
Time frame: 1 month
R-wave attenuation: R-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a R-wave amplitude at 1-month follow-up smaller or equal to 5.0 mV.
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 28 Nov 2013.
- Derived from this study: PubMed 25680307Bailey WM, Rosenthal L, Fananapazir L, Gleva M, Mazur A, Rinaldi CA, Kypta A, Merkely B, Woodard PK; ProMRI/ProMRI AFFIRM Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Jun;12(6):1183-91. doi: 10.1016/j.hrthm.2015.02.010. Epub 2015 Feb 11.
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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.
Aldo Rinaldi, Dr. principal investigator
Cardiology Department, St Thomas' Hospital Lambeth Palace Road London, SE1 7EH United Kingdom E-mail: Aldo.Rinaldi@gstt.nhs.uk
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Biotronik SE & Co. KG at 9 sites in 5 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 14 inclusion and 9 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 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Austria, Czechia, Switzerland, United Kingdom. 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?
Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate (time frame: 3 months). The study lists 4 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 NCT01460992, 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 28 Nov 2013.