Attain Performa(TM) Quadripolar Lead Study

NCT01751022 | Completed Results

• 1 other identifier: Attain Performa(TM)
• Study Type: interventional
• Target: 1,202
• Locations: 25 countries
• Sites: 114

Brief Summary

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.

Conditions

Heart Failure

Keywords

heart failure; cardiac pacing; cardiac resynchronization therapy; left ventricular lead

Outcome Measures

Primary Outcomes (2)

• Lead Complication-free Rate at 6 Months

  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

  6 months post-implant

Secondary Outcomes (7)

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

  6 months post-implant

• Percentage of Subjects With Successful Implant Per Attain Performa Lead Model

  Implant up to 1-month post implant

• Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model

  Implant up to 1-month post implant

• Pacing Capture Thresholds at the Final Programmed Pacing Polarity

  6 months post-implant

• Implant Related Times Per Attain Performa Lead Model

  Implant up to 1-month post implant

Study Arms (1)

Attain Performa LV Lead (Models 4298, 4398, 4598)

EXPERIMENTAL

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)

Interventions

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

Attain Performa LV Lead (Models 4298, 4398, 4598)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (121)

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Glendale, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Jose, California, United States

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Standford, California, United States

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West Hollywood, California, United States

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Hartford, Connecticut, United States

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Atlantis, Florida, United States

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Boca Raton, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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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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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Lansing, Michigan, United States

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Royal Oak, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Tupelo, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Henderson, Nevada, United States

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Morristown, New Jersey, United States

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Ridgewood, New Jersey, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Erie, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Greenville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Germantown, Tennessee, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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Temple, Texas, United States

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Burlington, Virginia, United States

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Fairfax, Virginia, United States

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Norfolk, Virginia, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, 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

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Graz, Austria

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Linz, Austria

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Genk, Belgium

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Yvoir, Belgium

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Calgary, Canada

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London, Canada

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Montreal, Canada

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Newmarket, Canada

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Québec, Canada

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Santiago, Chile

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Århus N, Denmark

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Copenhagen, Denmark

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Helsinki, Finland

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Nantes, France

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Rennes, France

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Rouen, France

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Bad Rothenfelde, Germany

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Bernau, Germany

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Bielefeld, Germany

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Chemnitz, Germany

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Heidelberg, Germany

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Trier, Germany

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Athens, Greece

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Budapest, Hungary

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Gurgaon, Haryana, India

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Dehli, India

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Ashkelon, Israel

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Bologna, Italy

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Cefalù, Italy

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Rovigo, Italy

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Kuala Lumpur, Malaysia

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Eindhoven, Netherlands

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Maastricht, Netherlands

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Nieuwegein, Netherlands

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Bergen, Norway

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Bucharest, Romania

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Riyadh, Saudi Arabia

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Belgrade, Serbia

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Kamenitz, Serbia

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Niš, Serbia

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Bratislava, Slovakia

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Košice, Slovakia

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Ljublijana, Slovenia

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Cape Town, South Africa

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Madrid, Spain

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Lausanne, Switzerland

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Bournemouth, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Shelby Li
• Organization: Medtronic

shelby.li@medtronic.com

+17635262704

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 17, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 5, 2016
• Results First Posted: December 5, 2016

Record last verified: 2016-10

Locations

MY (1); SE (3); CL (1); SL (1); FR (3); GR (1); IN (2); IL (1); NL (3); SA (1); ES (1); CH (1); FI (1); IT (3); CA (5); AU (2); US (67); NO (1); GB (3); RO (1); ZA (1); DE (6); DK (2); BE (2); HU (1)