QuickFlex Micro Left Ventricular Lead Post Approval Study

NCT01179477 | Completed Results

• 1 other identifier: CRD561
• Study Type: observational
• Target: 1,930
• Locations: 1 country
• Sites: 77

Brief Summary

The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.

Conditions

Heart Failure

Keywords

Left heart pacing lead; Cardiac resynchronization therapy (CRT); Heart failure

Outcome Measures

Primary Outcomes (2)

• Percent of Participants Alive and Without a Left Ventricular Lead-related Complication

  Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).

  5 years

• Left Ventricular Bipolar Pacing Capture Threshold

  Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up

  5 years

Interventions

Implantation of a QuickFlex® μ Model 1258T LV Lead DEVICE

Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead

Also known as: LV pacing lead

Eligibility Criteria

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

Study Population

Patients with an approved indication for implantation of a CRT-D system

You may qualify if:

• Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (IDE) study
• Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

You may not qualify if:

• Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
• Have a life expectancy of less than 5 years due to any condition
• Be less than 18 years of age

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (77)

Cardiovascular Associates P.C.

Birmingham, Alabama, 35213, United States

Location

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35294, United States

Location

Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

Alaska Heart Institute

Anchorage, Alaska, 99508, United States

Location

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85013, United States

Location

Arizona Arrhythmia Consultants

Scottsdale, Arizona, 85252, United States

Location

Arkansas Cardiology

Little Rock, Arkansas, 72205, United States

Location

St. Vincent Heart Clinic Arkansas

Little Rock, Arkansas, 72205, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Northwest Cardiology

Springdale, Arkansas, 72764, United States

Location

Glendale Memorial Hospital and Medical Center

Glendale, California, 91206, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

University of California at San Diego (UCSD) Medical Center

San Diego, California, 92118, United States

Location

Claudio Bonometti MD, Inc

Santa Barbara, California, 93105, United States

Location

Los Angeles Biomedical Research Institute at Harbor-UCLA

Torrance, California, 90502, United States

Location

Christiana Hospital

Newark, Delaware, 19713, United States

Location

Shands Jacksonville

Jacksonville, Florida, 32209, United States

Location

Naushad Shaik, MD

Kissimmee, Florida, 32804, United States

Location

Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Usman R. Siddiqui, MD

Orlando, Florida, 32803, United States

Location

Orlando Heart Center

Orlando, Florida, 32806, United States

Location

Brevard Cardiovascular Research Associates, Inc.

Rockledge, Florida, 32955, United States

Location

University of South Florida, Cardiovascular Services

Tampa, Florida, 33606, United States

Location

Athens Regional Medical Center

Athens, Georgia, 30306, United States

Location

St. Joseph's Hospital

Atlanta, Georgia, 30045, United States

Location

Redmond Regional Medical Center

Rome, Georgia, 30165, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46805, United States

Location

The Heart Group

Newburgh, Indiana, 47630, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Mid-America Cardiology Associates, PC

Kansas City, Kansas, 66160, United States

Location

King's Daughters Medical Center

Ashland, Kentucky, 41101, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Norton Bluegrass Heart Specialists

Louisville, Kentucky, 40217, United States

Location

Peninsula Cardiology Associates, P.A.

Salisbury, Maryland, 21804, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Trinity Health-Michigan d/b/a Michigan Heart

Ann Arbor, Michigan, 48197, United States

Location

Thoracic Cardio Healthcare Found. (aka Sparrow Research)

Lansing, Michigan, 48912, United States

Location

MidMichigan Physicians Group

Midland, Michigan, 48640, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Cardiology Associates of North Mississippi

Tupelo, Mississippi, 38801, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Heart Consultants P.C.

Omaha, Nebraska, 68122, United States

Location

AtlantiCare Regional Medical Center

Pomona, New Jersey, 08240, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

New Jersey Cardiology Associates

West Orange, New Jersey, 07052, United States

Location

Lenox Hill Hospital

New York, New York, 10028, United States

Location

LeBauer HeartCare

Greensboro, North Carolina, 27401, United States

Location

Wake Forest University Medical Center Clinical Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Primed Cardiology/Kettering Medical Center Network

Kettering, Ohio, 45429, United States

Location

Regional Cardiovascular Medical Center

Steubenville, Ohio, 43953, United States

Location

The Toledo Hospital

Toledo, Ohio, 43615, United States

Location

Toledo Clinic

Toledo, Ohio, 43623, United States

Location

St. Elizabeth Health Center

Youngstown, Ohio, 44505, United States

Location

Providence Heart and Vascular Institute

Portland, Oregon, 97220, United States

Location

Tri-State Medical Group Cardiology

Beaver, Pennsylvania, 15009, United States

Location

Capital Cardiovascular Associates

Camp Hill, Pennsylvania, 17011, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Donald Guthrie Foundation for Education and Research

Sayre, Pennsylvania, 18840, United States

Location

WellSpan Health

York, Pennsylvania, 17405, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Cardiology Consultants

Johnson City, Tennessee, 37601, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

The Stern Cardiovascular Foundation

Memphis, Tennessee, 38120, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

HeartPlace

Bedford, Texas, 76021, United States

Location

Advanced Heart Care

Plano, Texas, 75093, United States

Location

South Texas Cardiovascular Consultants

San Antonio, Texas, 78201, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

McKay-Dee Heart Services

Ogden, Utah, 84403, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Cardiovascular Associates Ltd

Chesapeake, Virginia, 23320, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

St. Mary's Hospital

Madison, Wisconsin, 53715, United States

Location

Cardiac Rhythm Specialists, S.C.

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clay Cohorn, Clinical Program Director
• Organization: Abbott

clay.cohorn@abbott.com

972-309-8087

Study Officials

• Clay Cohorn

  Abbott Medical Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 11, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 12, 2019
• Results First Posted: August 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (77)