Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

NCT ID: NCT01361685

Last Updated: 2021-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

366 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2021-02-04

Brief Summary

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Lead survivability will be summarized.

Detailed Description

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The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

Conditions

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Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive an Attain Ability Model 4396 LV lead
* Patient within 30 day post implant enrollment window

Exclusion Criteria

* Patient who is, or is expected to be inaccessible for follow-up
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Southwest EP Clinic

Gilbert, Arizona, United States

Site Status

Saint Vincent Heart Clinic Arkansas

Little Rock, Arkansas, United States

Site Status

Eisenhower Desert Cardiology Center

Rancho Mirage, California, United States

Site Status

COR Healthcare

Torrance, California, United States

Site Status

Cardiovascular Consultants Medical Group

Van Nuys, California, United States

Site Status

Colorado Heart and Vascular, PC

Lakewood, Colorado, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

MedStar Southern Maryland Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Bradenton Cardiology

Bradenton, Florida, United States

Site Status

Baptist Heart Specialists

Jacksonville, Florida, United States

Site Status

Indiana University Health - Methodist Research Institute

Indianapolis, Indiana, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

Louisville Cardiology Group

Louisville, Kentucky, United States

Site Status

Cenla Heart Specialists

Alexandria, Louisiana, United States

Site Status

Our Lady of the Lake Office of Research

Baton Rouge, Louisiana, United States

Site Status

Michigan Heart

Ypsilanti, Michigan, United States

Site Status

Metropolitan Cardiology Consultants PA

Coon Rapids, Minnesota, United States

Site Status

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

North Memorial Heart and Vascular Institute

Robbinsdale, Minnesota, United States

Site Status

HealthCare Partners Medical Group

Saint Louis Park, Minnesota, United States

Site Status

Saint Lukes Health System

Kansas City, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Patients First Health Care LLC

Washington, Missouri, United States

Site Status

New Jersey Cardiology Associates

West Orange, New Jersey, United States

Site Status

Presbyterian Heart Group

Albuquerque, New Mexico, United States

Site Status

NYU Langone Medical Center

New York, New York, United States

Site Status

New York-Presbyterian Hospital/Columbia University Medical Center

New York, New York, United States

Site Status

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

Site Status

Central New York Cardiology

Utica, New York, United States

Site Status

WakeMed Health & Hospitals

Raleigh, North Carolina, United States

Site Status

The Christ Hospital Health Network

Cincinnati, Ohio, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Site Status

Lehigh Valley Health Network

Bethlehem, Pennsylvania, United States

Site Status

Medicor Associates

Erie, Pennsylvania, United States

Site Status

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States

Site Status

Saint Thomas Research Institute

Nashville, Tennessee, United States

Site Status

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Site Status

Baylor Research Institute

Dallas, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

Baylor Research Institute

Plano, Texas, United States

Site Status

STAR Clinical Trials

San Antonio, Texas, United States

Site Status

EP Heart LLC

The Woodlands, Texas, United States

Site Status

The University of Vermont Medical Center

Burlington, Vermont, United States

Site Status

Aurora Cardiovascular Services

Milwaukee, Wisconsin, United States

Site Status

Queen's University & Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Centre Hospitalier de l'Universite de Montreal (CHUM) Hopital Hotel-Dieu

Montreal, Quebec, Canada

Site Status

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Québec, , Canada

Site Status

Universitatsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Site Status

Countries

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United States Canada Germany

Other Identifiers

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4396 Chronic Performance

Identifier Type: -

Identifier Source: org_study_id

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