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Completed

NCT Number: NCT01751022

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Randwick, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Implant and follow-up of study lead, separate analysis for each lead model

Primary outcomes

  1. Lead Complication-free Rate at 6 Months

    Time frame: Implant to 6 months post-implant

    The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following:

    • Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%).
    • Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months.

    The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models.

  2. LV Pacing Capture Thresholds Per Attain Performa Lead Model

    Time frame: 6 months post-implant

Secondary outcomes

  1. Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities

    Time frame: 6 months post-implant

    Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.

  2. Percentage of Subjects With Successful Implant Per Attain Performa Lead Model

    Time frame: Implant up to 1-month post implant

  3. Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model

    Time frame: Implant up to 1-month post implant

  4. Pacing Capture Thresholds at the Final Programmed Pacing Polarity

    Time frame: 6 months post-implant

  5. Implant Related Times Per Attain Performa Lead Model

    Time frame: Implant up to 1-month post implant

  6. Pacing Impedance at the Final Programmed Pacing Polarity

    Time frame: 6 month post-implant

    Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1.

    Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms).

  7. Complication Rate for Individual Attain Performa Lead Related Events

    Time frame: 6 month post-Implant

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2012
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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