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

Cardiac Disease Clinical Trial

— ProMRIAFFIRM  

Official title:

Master Study for the MRI Compatibility of the EVIA/ENTOVIS Pacemaker in Combination With Safio S Pacemaker Lead

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460992
• Other study ID #: 49
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: November 27, 2013
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES)
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Procedure:
• Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions
patients will undergo an MRI scan for 30 minutes.

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus Linz	Linz
Czech Republic	University Hospital Olomouc	Olomouc
Germany	St. Gertrauden Krankenhaus	Berlin
Germany	Städtisches Klinikum Dresden-Friedrichstadt	Dresden
Germany	Uniklinik Leipzig	Leipzig
Germany	Diakoniekrankenhaus Mannheim	Mannheim
Germany	DRK Krankenhaus Neuwied	Neuwied
Switzerland	Stadtspital Triemli	Zürich
United Kingdom	Cardiology Department, St Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes