ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads

NCT01460992 | Completed DMC

• 1 other identifier: 49
• Study Type: observational
• Target: 121
• Locations: 5 countries
• Sites: 9

Brief Summary

This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.

Conditions

Cardiac Disease

Keywords

Pacemaker therapy; Magnetic Resonance Imaging (MRI); EVIA/ENTOVIS

Outcome Measures

Primary Outcomes (4)

• 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%.

  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

  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

  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.

  1 month

Study Arms (1)

Pacemaker therapy

Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria.

Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions

Interventions

Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions PROCEDURE

patients will undergo an MRI scan for 30 minutes.

Also known as: 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

Pacemaker therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (9)

Allgemeines Krankenhaus Linz

Linz, 4021, Austria

Location

University Hospital Olomouc

Olomouc, Czechia

Location

St. Gertrauden Krankenhaus

Berlin, Germany

Location

Städtisches Klinikum Dresden-Friedrichstadt

Dresden, Germany

Location

Uniklinik Leipzig

Leipzig, Germany

Location

Diakoniekrankenhaus Mannheim

Mannheim, Germany

Location

DRK Krankenhaus Neuwied

Neuwied, Germany

Location

Stadtspital Triemli

Zurich, Switzerland

Location

Cardiology Department, St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25680307 DERIVED

MeSH Terms

Conditions

Heart Diseases

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Aldo Rinaldi, Dr.

  Cardiology Department, St Thomas' Hospital Lambeth Palace Road London, SE1 7EH United Kingdom E-mail: Aldo.Rinaldi@gstt.nhs.uk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 27, 2011
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

CH (1); AU (1); GB (1); CZ (1); DE (5)