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Attain Performa(TM) Quadripolar Lead Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01751022
First received: December 3, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Heart Failure
Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Attain Performa(TM) Quadripolar Lead Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Lead complication-free rate at 6 months [ Time Frame: Implant to 6 months post-implant ] [ Designated as safety issue: No ]
  • LV pacing capture thresholds per Attain Performa Lead Model [ Time Frame: 6 months post-implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with presence of PNS calculated for every LV lead pacing polarities that valid pacing capture thresholds can be obtained. [ Time Frame: 6 months post-implant ] [ Designated as safety issue: No ]
  • Proportion of subjects with successful implant per Attain Performa Lead Model [ Time Frame: Implant up to 1-month post implant ] [ Designated as safety issue: No ]
  • Rate of overall acceptable lead handling per Attain Performa Lead Model [ Time Frame: Implant up to 1-month post implant ] [ Designated as safety issue: No ]
    Implanter questionnaire to assess lead handling experience.

  • Pacing capture thresholds at the final programmed pacing polarity [ Time Frame: 12 months post-implant ] [ Designated as safety issue: No ]
  • Total implant time per Attain Performa Lead Model [ Time Frame: Implant up to 1-month post implant ] [ Designated as safety issue: No ]
  • Pacing impedance at the final programmed pacing polarity [ Time Frame: 12 month post-implant ] [ Designated as safety issue: No ]
  • Failure rate for individual Attain Performa Lead related events [ Time Frame: 6 month post-Implant ] [ Designated as safety issue: No ]
  • Fluoroscopy time per Attain Performa Lead Model [ Time Frame: Implant up to 1-month post implant ] [ Designated as safety issue: No ]
  • Cannulation time per Attain Performa Lead Model [ Time Frame: Implant up to 1-month post implant ] [ Designated as safety issue: No ]
  • LV Lead placement time per Attain Performa Lead Model [ Time Frame: Implant up to 1-month post implant ] [ Designated as safety issue: No ]

Estimated Enrollment: 1210
Study Start Date: December 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attain Performa LV Lead (Models 4298, 4398, 4598)
N/A: single arm study
Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Implant and follow-up of study lead

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751022

  Hide Study Locations
Locations
United States, California
Glendale, California, United States
Riverside, California, United States
San Diego, California, United States
San Jose, California, United States
Standford, California, United States
West Hollywood, California, United States
United States, Connecticut
Hartford, Connecticut, United States
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Atlantis, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
Maywood, Illinois, United States
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West Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Edgewood, Kentucky, United States
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Houma, Louisiana, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Kansas, Missouri, United States
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Lincoln, Nebraska, United States
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Henderson, Nevada, United States
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Randwick, New South Wales, Australia
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Chermside, Queensland, Australia
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Adelaide, South Australia, Australia
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Heidelberg, Victoria, Australia
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Perth, Western Australia, Australia
Austria
Graz, Austria
Linz, Austria
Belgium
Genk, Belgium
Yvoir, Belgium
Canada
Calgary, Canada
London, Canada
Montreal, Canada
Newmarket, Canada
Quebec, Canada
Chile
Santiago, Chile
Denmark
København, Denmark
Århus N, Denmark
Finland
Helsinki, Finland
France
Nantes, France
Rennes Cedex 9, France
Rouen Cedex, France
Germany
Bad Rothenfelde, Germany
Bernau, Germany
Bielefeld, Germany
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Heidelberg, Germany
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Greece
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Hungary
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India
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Ashkelon, Israel
Italy
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Rovigo, Italy
Malaysia
Kuala Lumpur, Malaysia
Netherlands
Eindhoven, Netherlands
Maastricht, Netherlands
Nieuwegein, Netherlands
Norway
Bergen, Norway
Romania
Bucuresti, Romania
Saudi Arabia
Riyadh, Saudi Arabia
Serbia
Beograd, Serbia
Niš, Serbia
Sremska Kamenica, Serbia
Slovakia
Bratislava 37, Slovakia
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Slovenia
Ljublijana, Slovenia
South Africa
Cape Town, South Africa
Spain
Madrid, Spain
Switzerland
Lausanne, Switzerland
United Kingdom
Bournemouth, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01751022     History of Changes
Other Study ID Numbers: Attain Performa(TM)
Study First Received: December 3, 2012
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
heart failure
cardiac pacing
cardiac resynchronization therapy
left ventricular lead

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014