Back to resultsModel 4396 Left Ventricular (LV) Lead Study (4396)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pacing Lead
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Model 4396 LV Lead
Arm Description
Non-randomized study.
Outcomes
Primary Outcome Measures
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).
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Fluoroscopy Time
The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
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.
Total Operation Time
Total operation time was defined as time from initial incision to final closure.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00853593
First Posted
February 26, 2009
Last Updated
January 31, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT00853593
Brief Title
Model 4396 Left Ventricular (LV) Lead Study
Acronym
4396
Official Title
Model 4396 Left Ventricular Lead Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Model 4396 LV Lead
Arm Type
Experimental
Arm Description
Non-randomized study.
Intervention Type
Device
Intervention Name(s)
Pacing Lead
Intervention Description
implant and follow-up of study device
Primary Outcome Measure Information:
Title
Safety (Subjects Without a Model 4396 Lead Related Complication)
Description
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).
Time Frame
One month
Title
Efficacy: Distal Tip Electrode Voltage Threshold
Description
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.
Time Frame
One month
Title
Efficacy: Proximal Ring Voltage Threshold
Description
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.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Subjects Successfully Implanted With Model 4396 Lead
Description
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.
Time Frame
During implant procedure.
Title
Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation
Description
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.
Time Frame
During implant procedure.
Title
Subjects Successfully Implanted With Any Transvenous LV Lead
Description
A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.
Time Frame
During implant procedure.
Title
Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead
Description
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.
Time Frame
During implant procedure.
Title
Cannulation Time
Description
Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.
Time Frame
During implant procedure.
Title
Fluoroscopy Time
Description
The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
Time Frame
During implant procedure.
Title
Model 4396 Lead Placement Time
Description
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.
Time Frame
During implant procedure.
Title
Total Operation Time
Description
Total operation time was defined as time from initial incision to final closure.
Time Frame
During implant procedure.
Title
Assessment of Lead Handling Characteristics Reported as Acceptable
Description
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.
Time Frame
During implant procedure.
Title
Efficacy: Bipolar Voltage Threshold
Description
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.
Time Frame
1 month
Title
Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold
Description
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.
Time Frame
6 month
Title
Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance
Description
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.
Time Frame
6 month
Title
Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing
Description
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.
Time Frame
6 month
Title
Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold
Description
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.
Time Frame
6 month
Title
Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance
Description
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.
Time Frame
6 month
Title
Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing
Description
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.
Time Frame
During implant procedure.
Title
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold
Description
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.
Time Frame
6 month
Title
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance
Description
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.
Time Frame
6 month
Title
Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing
Description
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.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Exner, MD
Organizational Affiliation
Foothills Hospital (University of Calgary)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Gras, MD
Organizational Affiliation
Nouvelles Cliniques Nantaises
Official's Role
Principal Investigator
Facility Information:
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Pasadena
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California
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United States
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Sacramento
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California
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United States
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Atlantis
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Atlanta
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Hinsdale
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Denmark
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Nantes
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France
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Toulouse
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France
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Treviso
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Italy
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Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Model 4396 Left Ventricular (LV) Lead Study
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