Model 4396 Left Ventricular (LV) Lead Study

NCT00853593 | Completed Results

• 1 other identifier: 116
• Study Type: interventional
• Target: 197
• Locations: 7 countries
• Sites: 30

Brief Summary

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Safety (Subjects Without a Model 4396 Lead Related Complication)

  A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).

  One month

• Efficacy: Distal Tip Electrode Voltage Threshold

  Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds \[ms\]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle.

  One month

• Efficacy: Proximal Ring Voltage Threshold

  Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts.

  Three months

Secondary Outcomes (19)

• Subjects Successfully Implanted With Model 4396 Lead

  During implant procedure.

• Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation

  During implant procedure.

• Subjects Successfully Implanted With Any Transvenous LV Lead

  During implant procedure.

• Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead

  During implant procedure.

• Cannulation Time

  During implant procedure.

Study Arms (1)

Model 4396 LV Lead

EXPERIMENTAL

Non-randomized study.

Device: Pacing Lead

Interventions

Pacing Lead DEVICE

implant and follow-up of study device

Model 4396 LV Lead

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (31)

Unknown Facility

Pasadena, California, United States

Location

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Sacramento, California, United States

Location

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Atlantis, Florida, United States

Location

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Atlanta, Georgia, United States

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Hinsdale, Illinois, United States

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Davenport, Iowa, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Saint Louis Park, Minnesota, United States

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Saint Paul, Minnesota, United States

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Liverpool, New York, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Portland, Oregon, United States

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York, Pennsylvania, United States

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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

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Linz, Austria

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Newmarket, Ontario, Canada

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Montreal, Quebec, Canada

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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

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Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: 4396 Clinical Research Specialist
• Organization: Medtronic, Inc

medtronicCRMtrials@medtronic.com

800-328-2518

Study Officials

• Derek Exner, MD

  Foothills Hospital (University of Calgary)

  PRINCIPAL INVESTIGATOR

• Daniel Gras, MD

  Nouvelles Cliniques Nantaises

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: February 26, 2009
• First Posted: March 2, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2010
• Last Updated: February 18, 2019
• Results First Posted: December 5, 2011

Record last verified: 2019-01

Locations

FR (2); SA (1); US (19); AU (1); CA (5); DK (1); IT (1)