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Attain Performa(TM) Quadripolar Lead Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT01751022
First received: December 3, 2012
Last updated: October 12, 2016
Last verified: October 2016
  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 and Heart Failure:

Primary Outcome Measures:
  • Lead Complication-free Rate at 6 Months [ Time Frame: Implant to 6 months post-implant ] [ Designated as safety issue: Yes ]

    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.


  • LV Pacing Capture Thresholds Per Attain Performa Lead Model [ Time Frame: 6 months post-implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities [ Time Frame: 6 months post-implant ] [ Designated as safety issue: No ]
    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.

  • Percentage 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 ]
  • Pacing Capture Thresholds at the Final Programmed Pacing Polarity [ Time Frame: 6 months post-implant ] [ Designated as safety issue: No ]
  • Implant Related Times 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: 6 month post-implant ] [ Designated as safety issue: No ]

    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).


  • Complication Rate for Individual Attain Performa Lead Related Events [ Time Frame: 6 month post-Implant ] [ Designated as safety issue: No ]

Enrollment: 1202
Study Start Date: December 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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, separate analysis for each lead model (total of 3).
Device: 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Show 121 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
  More Information

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01751022     History of Changes
Other Study ID Numbers: Attain Performa(TM) 
Study First Received: December 3, 2012
Results First Received: February 29, 2016
Last Updated: October 12, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
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 December 09, 2016