Attain Performa(TM) Quadripolar Lead Study

October 12, 2016 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia
    • Queensland
      • Chermside, Queensland, Australia
    • South Australia
      • Adelaide, South Australia, Australia
    • Victoria
      • Heidelberg, Victoria, Australia
    • Western Australia
      • 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
      • Chemnitz, Germany
      • Heidelberg, Germany
      • Trier, Germany
  • Greece
      • Athens, Greece
  • Hungary
      • Budapest, Hungary
  • India
      • Dehli, India
    • Haryana
      • Gurgaon, Haryana, India
  • Israel
      • Ashkelon, Israel
  • Italy
      • Bologna, Italy
      • Cefalù, Italy
      • 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
      • Kosice, Slovakia
  • 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
  • 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
    • Connecticut
      • Hartford, Connecticut, United States
    • Florida
      • Atlantis, Florida, United States
      • Boca Raton, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Jacksonville, Florida, United States
      • Orlando, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Maywood, Illinois, United States
    • Iowa
      • West Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Edgewood, Kentucky, United States
    • Louisiana
      • Houma, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Rockville, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Lansing, Michigan, United States
      • Royal Oak, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Saint Cloud, Minnesota, United States
      • Saint Louis Park, Minnesota, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • Missouri
      • Kansas, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • Nevada
      • Henderson, Nevada, United States
    • New Jersey
      • Morristown, New Jersey, United States
      • Ridgewood, New Jersey, United States
    • New York
      • New York, New York, United States
      • Stony Brook, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Winston Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
    • Pennsylvania
      • Erie, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Wilkes-Barre, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
    • South Carolina
      • Greenville, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Plano, Texas, United States
      • Temple, Texas, United States
    • Virginia
      • Burlington, Virginia, United States
      • Fairfax, Virginia, United States
      • Norfolk, Virginia, United States
    • West Virginia
      • Morgantown, West Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Implant to 6 months post-implant
LV Pacing Capture Thresholds Per Attain Performa Lead Model
Time Frame: 6 months post-implant
6 months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post-implant
Percentage of Subjects With Successful Implant Per Attain Performa Lead Model
Time Frame: Implant up to 1-month post implant
Implant up to 1-month post implant
Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model
Time Frame: Implant up to 1-month post implant
Implant up to 1-month post implant
Pacing Capture Thresholds at the Final Programmed Pacing Polarity
Time Frame: 6 months post-implant
6 months post-implant
Implant Related Times Per Attain Performa Lead Model
Time Frame: Implant up to 1-month post implant
Implant up to 1-month post implant
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).
6 month post-implant
Complication Rate for Individual Attain Performa Lead Related Events
Time Frame: 6 month post-Implant
6 month post-Implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Attain Performa(TM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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