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
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: Pacing Lead
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Model 4396 Left Ventricular Lead Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 197
Study Start Date: March 2009
Study Completion Date: August 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Model 4396 LV Lead
Non-randomized study.
Device: Pacing Lead
implant and follow-up of study device

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853593

  Show 31 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Derek Exner, MD Foothills Hospital (University of Calgary)
Principal Investigator: Daniel Gras, MD Nouvelles Cliniques Nantaises
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00853593     History of Changes
Other Study ID Numbers: 116
Study First Received: February 26, 2009
Results First Received: August 25, 2011
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Italy: Ministry of Health
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
heart failure
cardiac pacing
cardiac resynchronization therapy
left ventricular lead

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014