Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment

Cardiac Pacing Clinical Trial

Official title:

CapSureFix® Novus Model 5076 Lead MRI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755143
• Other study ID #: 5076 MRI
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: June 22, 2015
• Start date: December 2012
• Est. completion date: October 2013

Study information

• Verified date: June 2015
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: All geographies: Human Research Ethics Committee/Institutional Review BoardAustralia: Therapeutic Goods AdministrationColombia: INVIMATaiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects who have Class I and II indication for implantation of a dual chamber pacemaker according to the ACC/AHA/HRS guidelines

• Subjects who are able to undergo a pectoral implant

• Subjects who:

• are receiving an IPG for the first time, OR

• are receiving a replacement IPG connected to two previously- implanted (atrial and ventricular) Model 5076 leads

• Subjects who are able and willing to undergo elective MRI scanning without sedation

• Subjects who are geographically stable and available for follow-up at the study site for the length of the study

Exclusion Criteria:

• Subjects with a mechanical tricuspid heart valve.

• Subjects with a history of significant tricuspid valvular disease.

• Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.

• Subjects who require a legally authorized representative to obtain consent.

• Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads

• Subjects who are immediate candidates for an ICD.

• Subjects who require an indicated MRI scan, other than those specifically described in the study, before the one-month post MRI/waiting period follow-up.

• Subjects with previously implanted active medical devices (exception Model 5076 Lead and Advisa MRI IPG).

• Subjects with a non-MRI compatible device (such as ICDs or neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).

• Subjects with medical conditions that preclude the testing required by the protocol or limit study participation.

• Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study.

• Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.

• Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiac Pacing
• Magnetic Resonance Imaging (MRI)

Intervention

Other:
• Magnetic Resonance Imaging scan sequences of the head, neck, and chest

Device:
• Pacemaker System

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park
Australia	Saint George Hospital	Kogarah	New South Wales
Austria	Landesklinikum St. Pölten	Sankt Pölten
Austria	Wilhelminenspital	Wien
Belgium	Les Cliniques du Sud Luxembourg Cliniques Saint Joseph	Arlon
Belgium	Hôpital Saint-Joseph	Gilly
Chile	Hospital Clínico Pontificia Universidad Católica	Santiago
China	Prince of Wales Hospital Hong Kong	Hong Kong
Colombia	Fundacion Cardioinfantil	Bogota
Germany	Klinikum Links der Weser	Bremen
Germany	Praxisklinik Herz und Gefässe	Dresden
Germany	Universitätsklinikum Jena	Jena
Germany	Universitätsklinikum Ulm	Ulm
Hong Kong	Queen Mary Hospital	Hong Kong
India	Sri Jayadeva Institute of Cardiovascular Sciences and Research	Bangalore
India	Post Graduate Institute of Medical Education & Research	Chandigarh
India	Medanta The Medicity	Gurgaon	Haryana
India	Fortis Escorts Hospital	Jaipur
India	Holy Family Hospital	Mumbai
India	All India Institute of Medical Sciences	New Delhi
India	Dayanand Medical College	Punjab
Netherlands	HagaZiekenhuis - Locatie Leyweg	Den Haag
Netherlands	St. Antonius Ziekenhuis - Locatie Nieuwegein	Nieuwegein
Netherlands	Maasstad Ziekenhuis	Rotterdam
Portugal	Centro Hospitalar do Porto	Porto
Saudi Arabia	Prince Sultan Cardiac Center	Riyadh
Serbia	Klinicki Centar Srbije	Belgrade
Serbia	Institut za Kardiovaskularne Bolesti Vojvodine	Sremska Kamenica
Singapore	National Heart Centre Singapore	Singapore
Slovakia	Narodny ustav srdcovych a cievnych chorob	Bratislava
South Africa	Netcare Unitas Hospital	Pretoria
Spain	Hospital Universitari Clínic de Barcelona	Barcelona
Switzerland	HFR Fribourg - Hôpital cantonal	Fribourg
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Chile,  China,  Colombia,  Germany,  Hong Kong,  India,  Netherlands,  Portugal,  Saudi Arabia,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI-related Complication Free Rate	Number of patients free of MRI-related complications	MRI scan to one month later	No
Primary	Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds	Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.	Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period	No
Primary	Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds	Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.	Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period	No
Secondary	Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude	Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.	Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period	No
Secondary	Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.	The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the Adverse Events Adjudication Committee	During MRI scans (9-12 weeks post-implant)	No
Secondary	Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude	Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.	Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period	No