Model 4396 Left Ventricular (LV) Lead Study

NCT ID: NCT00853593

Last Updated: 2019-02-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-08-31

Brief Summary

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This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

Detailed Description

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This study is a prospective, multi-center, non-randomized design. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant. It also has statistical power to show effectiveness at one-month and three-months after implant.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Model 4396 LV Lead

Non-randomized study.

Group Type EXPERIMENTAL

Pacing Lead

Intervention Type DEVICE

implant and follow-up of study device

Interventions

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Pacing Lead

implant and follow-up of study device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* CRT/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications, New York Heart Association (NYHA) III and IV, indicated for implantable cardiac defibrillator (ICD) if CRT-D is implanted, patient consent, geographically stable

Exclusion Criteria

* LV lead implant attempt in last 30 days, unstable angina or acute myocardial infarction (MI) in past 30 days, coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 3 months, contraindicated for transvenous pacing, heart transplant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Derek Exner, MD

Role: PRINCIPAL_INVESTIGATOR

Foothills Hospital (University of Calgary)

Daniel Gras, MD

Role: PRINCIPAL_INVESTIGATOR

Nouvelles Cliniques Nantaises

Locations

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Pasadena, California, United States

Site Status

Sacramento, California, United States

Site Status

Atlantis, Florida, United States

Site Status

Atlanta, Georgia, United States

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Hinsdale, Illinois, United States

Site Status

Davenport, Iowa, United States

Site Status

Kansas City, Kansas, United States

Site Status

Lexington, Kentucky, United States

Site Status

Baton Rouge, Louisiana, United States

Site Status

Saint Louis Park, Minnesota, United States

Site Status

Saint Paul, Minnesota, United States

Site Status

Liverpool, New York, United States

Site Status

New York, New York, United States

Site Status

Durham, North Carolina, United States

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Portland, Oregon, United States

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York, Pennsylvania, United States

Site Status

Nashville, Tennessee, United States

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Austin, Texas, United States

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Morgantown, West Virginia, United States

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Bendigo, , Australia

Site Status

Linz, , Austria

Site Status

Calgary, Alberta, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Newmarket, Ontario, Canada

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Montreal, Quebec, Canada

Site Status

Québec, Quebec, Canada

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Aarhus, , Denmark

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Nantes, , France

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Toulouse, , France

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Treviso, , Italy

Site Status

Riyadh, , Saudi Arabia

Site Status

Countries

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United States Australia Austria Canada Denmark France Italy Saudi Arabia

Other Identifiers

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116

Identifier Type: -

Identifier Source: org_study_id

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