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

NCT01755143 | Completed Results

• 1 other identifier: 5076 MRI
• Study Type: interventional
• Target: 266
• Locations: 18 countries
• Sites: 34

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

Outcome Measures

Primary Outcomes (3)

• MRI-related Complication Free Rate

  Number of patients free of MRI-related complications

  MRI scan to one month later

• 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

• 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

Secondary Outcomes (3)

• Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude

  Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period

• Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.

  During MRI scans (9-12 weeks post-implant)

• Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude

  Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period

Study Arms (2)

MRI Group

EXPERIMENTAL

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

Other: Magnetic Resonance Imaging scan sequences of the head, neck, and chest; Device: Pacemaker System

Control Group

SHAM COMPARATOR

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.

Device: Pacemaker System

Interventions

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

MRI Group

Pacemaker System DEVICE

Also known as: Model 5076 Lead, Advisa MRI Pacemaker

Control Group; MRI Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (36)

Saint George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Flinders Medical Centre

Bedford Park, 5042, Australia

Location

Landesklinikum St. Pölten

Sankt Pölten, 3100, Austria

Location

Wilhelminenspital

Vienna, 1160, Austria

Location

Les Cliniques du Sud Luxembourg Cliniques Saint Joseph

Arlon, 6700, Belgium

Location

Hôpital Saint-Joseph

Gilly, 6060, Belgium

Location

Hospital Clínico Pontificia Universidad Católica

Santiago, 8320000, Chile

Location

Prince of Wales Hospital Hong Kong

Hong Kong, China

Location

Fundacion Cardioinfantil

Bogotá, 102973, Colombia

Location

Klinikum Links der Weser

Bremen, 28277, Germany

Location

Praxisklinik Herz und Gefässe

Dresden, 01099, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Medanta The Medicity

Gurgaon, Haryana, 122041, India

Location

Sri Jayadeva Institute of Cardiovascular Sciences and Research

Bangalore, India

Location

Post Graduate Institute of Medical Education & Research

Chandigarh, 160012, India

Location

Fortis Escorts Hospital

Jaipur, 302017, India

Location

Holy Family Hospital

Mumbai, 400050, India

Location

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Dayanand Medical College

Punjab, 141001, India

Location

St. Antonius Ziekenhuis - Locatie Nieuwegein

Nieuwegein, 3435, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, 3078, Netherlands

Location

HagaZiekenhuis - Locatie Leyweg

The Hague, 2545, Netherlands

Location

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Location

Prince Sultan Cardiac Center

Riyadh, Saudi Arabia

Location

Klinicki Centar Srbije

Belgrade, 11000, Serbia

Location

Institut za Kardiovaskularne Bolesti Vojvodine

Kamenitz, 21204, Serbia

Location

National Heart Centre Singapore

Singapore, 168752, Singapore

Location

Narodny ustav srdcovych a cievnych chorob

Bratislava, 83348, Slovakia

Location

Netcare Unitas Hospital

Pretoria, 0140, South Africa

Location

Hospital Universitari Clínic de Barcelona

Barcelona, 08036, Spain

Location

HFR Fribourg - Hôpital cantonal

Fribourg, 1708, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Results Point of Contact

• Title: 5076MRI Clinical Team
• Organization: Medtronic Cardiac Rhythm and Heart Failure

MedtronicCRMtrials@medtronic.com

1-800-328-2518

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 24, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 20, 2015
• Results First Posted: July 20, 2015

Record last verified: 2015-06

Locations

ES (1); CH (2); AU (2); SA (1); SE (2); HK (1); PT (1); BE (2); IN (7); SL (1); DE (4); CN (1); TW (2); CL (1); NL (3); SG (1); CO (1); ZA (1)