Model 4396 Left Ventricular (LV) Lead Study (4396)

Model 4396 Left Ventricular Lead Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Pacing Lead

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.

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Bendigo, Australia
• Austria
  • Linz, Austria
• Canada
  • Alberta
    • Calgary, Alberta, Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
  • Ontario
    • Newmarket, Ontario, Canada
  • Quebec
    • Montreal, Quebec, Canada
    • Quebec City, Quebec, Canada
• Denmark
  • Aarhus, Denmark
• France
  • Nantes, France
  • Toulouse, France
• Italy
  • Treviso, Italy
• Saudi Arabia
  • Riyadh, Saudi Arabia
• United States
  • California
    • Pasadena, California, United States
    • Sacramento, California, United States
  • Florida
    • Atlantis, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
  • Illinois
    • Hinsdale, Illinois, United States
  • Iowa
    • Davenport, Iowa, United States
  • Kansas
    • Kansas City, Kansas, United States
  • Kentucky
    • Lexington, Kentucky, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
  • Minnesota
    • Saint Louis Park, Minnesota, United States
    • Saint Paul, Minnesota, United States
  • New York
    • Liverpool, New York, United States
    • New York, New York, United States
  • North Carolina
    • Durham, North Carolina, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • York, Pennsylvania, United States
  • Tennessee
    • Nashville, Tennessee, United States
  • Texas
    • Austin, Texas, United States
  • West Virginia
    • Morgantown, West Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Model 4396 LV Lead; Non-randomized study.	Device: Pacing Lead; implant and follow-up of study device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Successfully Implanted With Model 4396 Lead	A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body.	During implant procedure.
Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation	A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body.	During implant procedure.
Subjects Successfully Implanted With Any Transvenous LV Lead	A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.	During implant procedure.
Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead	A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396.	During implant procedure.
Cannulation Time	Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.	During implant procedure.
Fluoroscopy Time	The total time the fluoroscope was imaging (not including biplane fluoroscopy time).	During implant procedure.
Model 4396 Lead Placement Time	Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location.	During implant procedure.
Total Operation Time	Total operation time was defined as time from initial incision to final closure.	During implant procedure.
Assessment of Lead Handling Characteristics Reported as Acceptable	Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized.	During implant procedure.
Efficacy: Bipolar Voltage Threshold	Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds [ms]) is less than or equal to 4.0 Volts.	1 month
Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold	Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized.	6 month
Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance	Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.	6 month
Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing	Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense.	6 month
Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold	Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here.	6 month
Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance	Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.	6 month
Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing	Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements.	During implant procedure.
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold	Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here.	6 month
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance	Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.	6 month
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing	Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here.	6 month

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Derek Exner, MD, Foothills Hospital (University of Calgary); Principal Investigator: Daniel Gras, MD, Nouvelles Cliniques Nantaises

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: February 26, 2009
• First Submitted That Met QC Criteria: February 27, 2009
• First Posted (Estimate): March 2, 2009

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: cardiac resynchronization therapy; heart failure; left ventricular lead; cardiac pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 116