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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01755143




Registration number
NCT01755143
Ethics application status
Date submitted
18/12/2012
Date registered
24/12/2012
Date last updated
20/07/2015

Titles & IDs
Public title
Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment
Scientific title
CapSureFix® Novus Model 5076 Lead MRI Study
Secondary ID [1] 0 0
5076 MRI
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Magnetic Resonance Imaging (MRI) 0 0
Cardiac Pacing 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Magnetic Resonance Imaging scan sequences of the head, neck, and chest
Treatment: Devices - Pacemaker System

Experimental: 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.

Sham Comparator: 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.


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


Treatment: Devices: Pacemaker System
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MRI-related Complication Free Rate
Timepoint [1] 0 0
MRI scan to one month later
Primary outcome [2] 0 0
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds
Timepoint [2] 0 0
Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Primary outcome [3] 0 0
Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds
Timepoint [3] 0 0
Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period
Secondary outcome [1] 0 0
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude
Timepoint [1] 0 0
Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period
Secondary outcome [2] 0 0
Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.
Timepoint [2] 0 0
During MRI scans (9-12 weeks post-implant)
Secondary outcome [3] 0 0
Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude
Timepoint [3] 0 0
Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
266
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Saint George Hospital - Kogarah
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Sankt Pölten
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Arlon
Country [4] 0 0
Belgium
State/province [4] 0 0
Gilly
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
China
State/province [6] 0 0
Hong Kong
Country [7] 0 0
Colombia
State/province [7] 0 0
Bogota
Country [8] 0 0
Germany
State/province [8] 0 0
Bremen
Country [9] 0 0
Germany
State/province [9] 0 0
Dresden
Country [10] 0 0
Germany
State/province [10] 0 0
Jena
Country [11] 0 0
Germany
State/province [11] 0 0
Ulm
Country [12] 0 0
Hong Kong
State/province [12] 0 0
Hong Kong
Country [13] 0 0
India
State/province [13] 0 0
Haryana
Country [14] 0 0
India
State/province [14] 0 0
Bangalore
Country [15] 0 0
India
State/province [15] 0 0
Chandigarh
Country [16] 0 0
India
State/province [16] 0 0
Jaipur
Country [17] 0 0
India
State/province [17] 0 0
Mumbai
Country [18] 0 0
India
State/province [18] 0 0
New Delhi
Country [19] 0 0
India
State/province [19] 0 0
Punjab
Country [20] 0 0
Netherlands
State/province [20] 0 0
Den Haag
Country [21] 0 0
Netherlands
State/province [21] 0 0
Nieuwegein
Country [22] 0 0
Netherlands
State/province [22] 0 0
Rotterdam
Country [23] 0 0
Portugal
State/province [23] 0 0
Porto
Country [24] 0 0
Saudi Arabia
State/province [24] 0 0
Riyadh
Country [25] 0 0
Serbia
State/province [25] 0 0
Belgrade
Country [26] 0 0
Serbia
State/province [26] 0 0
Sremska Kamenica
Country [27] 0 0
Singapore
State/province [27] 0 0
Singapore
Country [28] 0 0
Slovakia
State/province [28] 0 0
Bratislava
Country [29] 0 0
South Africa
State/province [29] 0 0
Pretoria
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Switzerland
State/province [31] 0 0
Fribourg
Country [32] 0 0
Switzerland
State/province [32] 0 0
Lausanne
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01755143
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01755143