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Trial record 1 of 2 for:    Attain Performa
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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

December 3, 2012
March 17, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01751022 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Attain Performa(TM) Quadripolar Lead Study
Attain Performa(TM) Quadripolar Lead Study

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Implant and follow-up of study lead
Experimental: Attain Performa LV Lead (Models 4298, 4398, 4598)
N/A: single arm study
Intervention: Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1210
February 2016
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Chile,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Malaysia,   Netherlands,   Norway,   Romania,   Saudi Arabia,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Switzerland,   United Kingdom
 
NCT01751022
Attain Performa(TM)
Not Provided
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Not Provided
Medtronic Cardiac Rhythm Disease Management
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP