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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01751022




Registration number
NCT01751022
Ethics application status
Date submitted
3/12/2012
Date registered
17/12/2012
Date last updated
5/12/2016

Titles & IDs
Public title
Attain Performa(TM) Quadripolar Lead Study
Scientific title
Attain Performa(TM) Quadripolar Lead Study
Secondary ID [1] 0 0
Attain Performa(TM)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Device: Attain Performa Pacing Lead (along with a standard CRT-D system)

Experimental: Attain Performa LV Lead (Models 4298, 4398, 4598) - N/A: single arm study, separate analysis for each lead model (total of 3).


Treatment: Devices: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Implant and follow-up of study lead, separate analysis for each lead model
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lead Complication-free Rate at 6 Months
Timepoint [1] 0 0
Implant to 6 months post-implant
Primary outcome [2] 0 0
LV Pacing Capture Thresholds Per Attain Performa Lead Model
Timepoint [2] 0 0
6 months post-implant
Secondary outcome [1] 0 0
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
Timepoint [1] 0 0
6 months post-implant
Secondary outcome [2] 0 0
Percentage of Subjects With Successful Implant Per Attain Performa Lead Model
Timepoint [2] 0 0
Implant up to 1-month post implant
Secondary outcome [3] 0 0
Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model
Timepoint [3] 0 0
Implant up to 1-month post implant
Secondary outcome [4] 0 0
Pacing Capture Thresholds at the Final Programmed Pacing Polarity
Timepoint [4] 0 0
6 months post-implant
Secondary outcome [5] 0 0
Implant Related Times Per Attain Performa Lead Model
Timepoint [5] 0 0
Implant up to 1-month post implant
Secondary outcome [6] 0 0
Pacing Impedance at the Final Programmed Pacing Polarity
Timepoint [6] 0 0
6 month post-implant
Secondary outcome [7] 0 0
Complication Rate for Individual Attain Performa Lead Related Events
Timepoint [7] 0 0
6 month post-Implant

Eligibility
Key inclusion criteria
* Patient is indicated for implant of a CRT-D device and left-heart lead per local indications (In US only this is based on Class I and II indications for CRT-D implant per HRS/ACC/AHA guidelines)
* Patient (or legally authorized representative) has signed and dated the study-specific Consent Form
* Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
* Patient is expected to remain available for follow-up visits
* Patient understands the study and agrees to comply with study protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient has a previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt
* Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
* Patient has had a heart transplant (Note: Patients waiting for heart transplants are allowed in the study)
* Patient is contraindicated for < 1 mg dexamethasone acetate
* Patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (Note: Co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from Medtronic's study manager)
* Patient has a life expectancy less than 180 days
* Patient with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)

* In US, women of childbearing potential must have a negative pregnancy test 7 days prior to implant to be included
* Patient is unable to tolerate an urgent thoracotomy

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
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
1/02/2015
Sample size
Target
Accrual to date
Final
1202
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- Chermside
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Heidelberg
Recruitment hospital [5] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Chermside
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Connecticut
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Florida
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Georgia
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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North Dakota
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Graz
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Genk
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Bielefeld
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Chemnitz
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Heidelberg
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Trier
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Greece
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Athens
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Hungary
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Budapest
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India
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Haryana
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India
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Dehli
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Israel
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Ashkelon
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Italy
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Bologna
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Cefalù
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Italy
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Rovigo
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Malaysia
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Netherlands
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Eindhoven
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Maastricht
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Nieuwegein
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Norway
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Bergen
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Romania
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Bucuresti
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Saudi Arabia
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Riyadh
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Serbia
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Beograd
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Serbia
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Niš
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Serbia
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Sremska Kamenica
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Slovakia
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Bratislava 37
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Slovakia
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Kosice
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Slovenia
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Ljublijana
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South Africa
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Cape Town
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Spain
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Madrid
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Switzerland
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Lausanne
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Bournemouth
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London
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Manchester

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 the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.
Trial website
https://clinicaltrials.gov/study/NCT01751022
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/study/NCT01751022