Clinical trial NCT00433654: EMRI SureScan™ Clinical Study
Official title: EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Slow Heart Beat
Keywords: Bradycardia
Slow heart beat
Magnetic resonance imaging (MRI)
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2007-02-12
Enrollment: 484
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

Detailed description: This study is a prospective, multi-center global study.

Eligibility criteria: Inclusion Criteria:

* Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker.
* Subject available for follow-up at study center for length of study.
* Subject able and willing to undergo elective MRI scanning without sedation.

Exclusion Criteria:

* Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).
* Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period.
* Pregnant women, or women of child bearing potential who are not on a reliable form of birth control.
* Subject with exclusion criteria required by local law.
* Subject who intends to participate in another clinical study during this clinical study.

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI)-Related Complications
timeFrame: MRI scan to one-month post-MRI scan
measure: Atrial Pacing Capture Threshold Success
timeFrame: 9-12 week visit to 4-month visit
measure: Ventricular Pacing Capture Threshold Success
timeFrame: 9-12 week visit to 4-month visit
measure: Atrial Sensed Amplitude Success
timeFrame: 9-12 week visit to 4-month visit
measure: Ventricular Sensed Amplitude Success
timeFrame: 9-12 week visit to 4-month visit
Secondary outcomes:
measure: Subjects With System-related Complications
timeFrame: Implant to 4 Months
measure: System Related Adverse Device Effects Due to Labeling Instructions
timeFrame: Implant through 18 months post-implant
measure: Occurrence of Arrhythmias
timeFrame: During the MRI scan
measure: Atrial Lead Impedance Change
timeFrame: 9-12 week visit and 4-month visit
measure: Ventricular Lead Impedance Change
timeFrame: 9-12 week visit and 4-month visit
measure: Atrial Lead Handling Rating
timeFrame: During implant
measure: Ventricular Lead Handling Rating
timeFrame: During implant
measure: Atrial Pacing Capture Threshold
timeFrame: 3 or 4 months post-implant
measure: Ventricular Pacing Capture Threshold
timeFrame: 3 or 4 months post-implant
measure: Atrial Sensed Amplitude
timeFrame: 3 or 4 months post-implant
measure: Ventricular Sensed Amplitude
timeFrame: 3 or 4 months post-implant
Other outcomes:
Locations:
city: Redwood City
country: United States
state: California
city: Salinas
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Peachtree City
country: United States
state: Georgia
city: Des Moines
country: United States
state: Iowa
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Mineola
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Erie
country: United States
state: Pennsylvania
city: Knoxville
country: United States
state: Tennessee
city: Charlottesville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Graz
country: Austria
city: Linz
country: Austria
city: Liège
country: Belgium
city: Mons
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: Prague
country: Czech Republic
city: Rouen
country: France
city: Bad Nauheim
country: Germany
city: Bonn
country: Germany
city: Dortmund
country: Germany
city: Dresden
country: Germany
city: Essen
country: Germany
city: Gottingen
country: Germany
city: Hamburg
country: Germany
city: Marburg
country: Germany
city: München
country: Germany
city: Ulm
country: Germany
city: Asti
country: Italy
city: Pescia
country: Italy
city: Pietra Ligure
country: Italy
city: Viterbo
country: Italy
city: Amsterdam
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Zurich
country: Switzerland
city: London
country: United Kingdom
Study officials:
affiliation: Medtronic
name: EMRI SureScan Clinical Study Team
role: STUDY_CHAIR
References:
citation: Sutton R, Kanal E, Wilkoff BL, Bello D, Luechinger R, Jenniskens I, Hull M, Sommer T. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. 2008 Dec 2;9:68. doi: 10.1186/1745-6215-9-68.