Clinical trial NCT01751022: Attain Performa(TM) Quadripolar Lead Study
Official title: Attain Performa(TM) Quadripolar Lead Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
cardiac pacing
cardiac resynchronization therapy
left ventricular lead
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 1202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Lead Complication-free Rate at 6 Months
timeFrame: Implant to 6 months post-implant
measure: LV Pacing Capture Thresholds Per Attain Performa Lead Model
timeFrame: 6 months post-implant
Secondary outcomes:
measure: Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
timeFrame: 6 months post-implant
measure: Percentage of Subjects With Successful Implant Per Attain Performa Lead Model
timeFrame: Implant up to 1-month post implant
measure: Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model
timeFrame: Implant up to 1-month post implant
measure: Pacing Capture Thresholds at the Final Programmed Pacing Polarity
timeFrame: 6 months post-implant
measure: Implant Related Times Per Attain Performa Lead Model
timeFrame: Implant up to 1-month post implant
measure: Pacing Impedance at the Final Programmed Pacing Polarity
timeFrame: 6 month post-implant
measure: Complication Rate for Individual Attain Performa Lead Related Events
timeFrame: 6 month post-Implant
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Jose
country: United States
state: California
city: Standford
country: United States
state: California
city: West Hollywood
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state: California
city: Hartford
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state: Connecticut
city: Atlantis
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city: Boca Raton
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city: Fort Lauderdale
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city: Orlando
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state: Florida
city: Atlanta
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state: Maryland
city: Rockville
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city: Boston
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state: Massachusetts
city: Ann Arbor
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state: Michigan
city: Lansing
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city: Royal Oak
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city: Minneapolis
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city: Stony Brook
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city: Durham
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state: Oregon
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city: Lancaster
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city: Pittsburgh
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city: Wilkes-Barre
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city: Greenville
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state: South Carolina
city: Spartanburg
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state: South Carolina
city: Germantown
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state: Tennessee
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city: Nashville
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state: Tennessee
city: Austin
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city: Dallas
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city: Norfolk
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state: West Virginia
city: Milwaukee
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state: Wisconsin
city: Randwick
country: Australia
state: New South Wales
city: Chermside
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Heidelberg
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Graz
country: Austria
city: Linz
country: Austria
city: Genk
country: Belgium
city: Yvoir
country: Belgium
city: Calgary
country: Canada
city: London
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city: Montreal
country: Canada
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country: Canada
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country: Canada
city: Santiago
country: Chile
city: København
country: Denmark
city: Århus N
country: Denmark
city: Helsinki
country: Finland
city: Nantes
country: France
city: Rennes Cedex 9
country: France
city: Rouen Cedex
country: France
city: Bad Rothenfelde
country: Germany
city: Bernau
country: Germany
city: Bielefeld
country: Germany
city: Chemnitz
country: Germany
city: Heidelberg
country: Germany
city: Trier
country: Germany
city: Athens
country: Greece
city: Budapest
country: Hungary
city: Gurgaon
country: India
state: Haryana
city: Dehli
country: India
city: Ashkelon
country: Israel
city: Bologna
country: Italy
city: Cefalù
country: Italy
city: Rovigo
country: Italy
city: Kuala Lumpur
country: Malaysia
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country: Netherlands
city: Maastricht
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Bergen
country: Norway
city: Bucuresti
country: Romania
city: Riyadh
country: Saudi Arabia
city: Beograd
country: Serbia
city: Niš
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Bratislava 37
country: Slovakia
city: Kosice
country: Slovakia
city: Ljublijana
country: Slovenia
city: Cape Town
country: South Africa
city: Madrid
country: Spain
city: Lausanne
country: Switzerland
city: Bournemouth
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
References: