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

NCT ID: NCT01755143

Last Updated: 2015-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-10-31

Brief 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.

Conditions

Magnetic Resonance Imaging (MRI); Cardiac Pacing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

MRI Group

Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Pacemaker System

Intervention Type: DEVICE

Control Group

Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.

Group Type: SHAM_COMPARATOR

Pacemaker System

Intervention Type: DEVICE

Interventions

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

Intervention Type: OTHER

Pacemaker System

Intervention Type: DEVICE

Other Intervention Names

Model 5076 Lead; Advisa MRI Pacemaker

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saint George Hospital

Kogarah, New South Wales, Australia

Flinders Medical Centre

Bedford Park, , Australia

Landesklinikum St. Pölten

Sankt Pölten, , Austria

Wilhelminenspital

Vienna, , Austria

Les Cliniques du Sud Luxembourg Cliniques Saint Joseph

Arlon, , Belgium

Hôpital Saint-Joseph

Gilly, , Belgium

Hospital Clínico Pontificia Universidad Católica

Santiago, , Chile

Prince of Wales Hospital Hong Kong

Hong Kong, , China

Fundacion Cardioinfantil

Bogotá, , Colombia

Klinikum Links der Weser

Bremen, , Germany

Praxisklinik Herz und Gefässe

Dresden, , Germany

Universitätsklinikum Jena

Jena, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Queen Mary Hospital

Hong Kong, , Hong Kong

Medanta The Medicity

Gurgaon, Haryana, India

Sri Jayadeva Institute of Cardiovascular Sciences and Research

Bangalore, , India

Post Graduate Institute of Medical Education & Research

Chandigarh, , India

Fortis Escorts Hospital

Jaipur, , India

Holy Family Hospital

Mumbai, , India

All India Institute of Medical Sciences

New Delhi, , India

Dayanand Medical College

Punjab, , India

St. Antonius Ziekenhuis - Locatie Nieuwegein

Nieuwegein, , Netherlands

Maasstad Ziekenhuis

Rotterdam, , Netherlands

HagaZiekenhuis - Locatie Leyweg

The Hague, , Netherlands

Centro Hospitalar do Porto

Porto, , Portugal

Prince Sultan Cardiac Center

Riyadh, , Saudi Arabia

Klinicki Centar Srbije

Belgrade, , Serbia

Institut za Kardiovaskularne Bolesti Vojvodine

Kamenitz, , Serbia

National Heart Centre Singapore

Singapore, , Singapore

Narodny ustav srdcovych a cievnych chorob

Bratislava, , Slovakia

Netcare Unitas Hospital

Pretoria, , South Africa

Hospital Universitari Clínic de Barcelona

Barcelona, , Spain

HFR Fribourg - Hôpital cantonal

Fribourg, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

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

Other Identifiers

5076 MRI

Identifier Type: -

Identifier Source: org_study_id