Clinical trial NCT00853593: Model 4396 Left Ventricular (LV) Lead Study
Official title: Model 4396 Left Ventricular Lead Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
cardiac pacing
cardiac resynchronization therapy
left ventricular lead
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety (Subjects Without a Model 4396 Lead Related Complication)
timeFrame: One month
measure: Efficacy: Distal Tip Electrode Voltage Threshold
timeFrame: One month
measure: Efficacy: Proximal Ring Voltage Threshold
timeFrame: Three months
Secondary outcomes:
measure: Subjects Successfully Implanted With Model 4396 Lead
timeFrame: During implant procedure.
measure: Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation
timeFrame: During implant procedure.
measure: Subjects Successfully Implanted With Any Transvenous LV Lead
timeFrame: During implant procedure.
measure: Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead
timeFrame: During implant procedure.
measure: Cannulation Time
timeFrame: During implant procedure.
measure: Fluoroscopy Time
timeFrame: During implant procedure.
measure: Model 4396 Lead Placement Time
timeFrame: During implant procedure.
measure: Total Operation Time
timeFrame: During implant procedure.
measure: Assessment of Lead Handling Characteristics Reported as Acceptable
timeFrame: During implant procedure.
measure: Efficacy: Bipolar Voltage Threshold
timeFrame: 1 month
measure: Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold
timeFrame: 6 month
measure: Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance
timeFrame: 6 month
measure: Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing
timeFrame: 6 month
measure: Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold
timeFrame: 6 month
measure: Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance
timeFrame: 6 month
measure: Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing
timeFrame: During implant procedure.
measure: Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold
timeFrame: 6 month
measure: Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance
timeFrame: 6 month
measure: Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing
timeFrame: 6 month
Other outcomes:
Locations:
city: Pasadena
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Atlantis
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Hinsdale
country: United States
state: Illinois
city: Davenport
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Saint Louis Park
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Liverpool
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: York
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Morgantown
country: United States
state: West Virginia
city: Bendigo
country: Australia
city: Linz
country: Austria
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Newmarket
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Aarhus
country: Denmark
city: Nantes
country: France
city: Toulouse
country: France
city: Treviso
country: Italy
city: Riyadh
country: Saudi Arabia
Study officials:
affiliation: Foothills Hospital (University of Calgary)
name: Derek Exner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nouvelles Cliniques Nantaises
name: Daniel Gras, MD
role: PRINCIPAL_INVESTIGATOR
References: