Model 4396 Left Ventricular (LV) Lead Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00853593
First received: February 26, 2009
Last updated: February 1, 2012
Last verified: February 2012

February 26, 2009
February 1, 2012
March 2009
July 2009   (final data collection date for primary outcome measure)
  • Safety (Subjects Without a Model 4396 Lead Related Complication) [ Time Frame: One month ] [ Designated as safety issue: No ]
    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).
  • Efficacy: Distal Tip Electrode Voltage Threshold [ Time Frame: One month ] [ Designated as safety issue: No ]
    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.
  • Efficacy: Proximal Ring Voltage Threshold [ Time Frame: Three months ] [ Designated as safety issue: No ]
    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.
  • The distal tip electrode of the LV lead will be considered effective if the mean LV voltage threshold at the 1-month visit using the LV tip to RV coil configuration is less than 3.0 Volts. [ Time Frame: implant to one month post-implant ] [ Designated as safety issue: No ]
  • The proximal ring electrode of the LV lead will be considered effective if the mean LV voltage threshold at the 3-month visit using the LV ring to RV coil configuration is less than 4.0 Volts. [ Time Frame: implant to three months post-implant ] [ Designated as safety issue: No ]
  • Safety is measured by LV lead related complications at the 1-month visit [ Time Frame: implant to one month post-implant ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00853593 on ClinicalTrials.gov Archive Site
  • Subjects Successfully Implanted With Model 4396 Lead [ Time Frame: During implant procedure. ] [ Designated as safety issue: No ]
    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.
  • Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation [ Time Frame: During implant procedure. ] [ Designated as safety issue: No ]
    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.
  • Subjects Successfully Implanted With Any Transvenous LV Lead [ Time Frame: During implant procedure. ] [ Designated as safety issue: No ]
    A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.
  • Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead [ Time Frame: During implant procedure. ] [ Designated as safety issue: No ]
    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.
  • Cannulation Time [ Time Frame: During implant procedure. ] [ Designated as safety issue: No ]
    Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.
  • Fluoroscopy Time [ Time Frame: During implant procedure. ] [ Designated as safety issue: No ]
    The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
  • Model 4396 Lead Placement Time [ Time Frame: During implant procedure. ] [ Designated as safety issue: No ]
    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.
  • Total Operation Time [ Time Frame: During implant procedure. ] [ Designated as safety issue: No ]
    Total operation time was defined as time from initial incision to final closure.
  • Assessment of Lead Handling Characteristics Reported as Acceptable [ Time Frame: During implant procedure. ] [ Designated as safety issue: No ]
    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.
  • Efficacy: Bipolar Voltage Threshold [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.
  • Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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.
  • Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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.
  • Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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.
  • Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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.
  • Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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.
  • Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing [ Time Frame: During implant procedure. ] [ Designated as safety issue: No ]
    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.
  • Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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.
  • Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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.
  • Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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.
Evaluate effectiveness of bipolar configuration [ Time Frame: One-month visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Model 4396 Left Ventricular (LV) Lead Study
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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Device: Pacing Lead
implant and follow-up of study device
Experimental: Model 4396 LV Lead
Non-randomized study.
Intervention: Device: Pacing Lead
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
August 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Saudi Arabia,   Australia,   Austria,   Canada,   Denmark,   France,   Italy
 
NCT00853593
116
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Principal Investigator: Derek Exner, MD Foothills Hospital (University of Calgary)
Principal Investigator: Daniel Gras, MD Nouvelles Cliniques Nantaises
Medtronic Cardiac Rhythm Disease Management
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP