Model 4396 Left Ventricular (LV) Lead Study

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00853593
• Collaborator: (none)
• Enrollment: 197
• Locations: 31
• Arm: 1
• Duration (Months): 17
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Pacing Lead	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 197 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Model 4396 Left Ventricular Lead Study
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety (Subjects Without a Model 4396 Lead Related Complication) [One month]

   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).

2. Efficacy: Distal Tip Electrode Voltage Threshold [One month]

   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.

3. Efficacy: Proximal Ring Voltage Threshold [Three months]

   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

1. Subjects Successfully Implanted With Model 4396 Lead [During implant procedure.]

   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.

2. Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation [During implant procedure.]

   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.

3. Subjects Successfully Implanted With Any Transvenous LV Lead [During implant procedure.]

   A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.

4. Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead [During implant procedure.]

   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.

5. Cannulation Time [During implant procedure.]

   Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.

6. Fluoroscopy Time [During implant procedure.]

   The total time the fluoroscope was imaging (not including biplane fluoroscopy time).

7. Model 4396 Lead Placement Time [During implant procedure.]

   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.

8. Total Operation Time [During implant procedure.]

   Total operation time was defined as time from initial incision to final closure.

9. Assessment of Lead Handling Characteristics Reported as Acceptable [During implant procedure.]

   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.

10. Efficacy: Bipolar Voltage Threshold [1 month]

    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.

11. Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold [6 month]

    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.

12. Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance [6 month]

    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.

13. Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing [6 month]

    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.

14. Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold [6 month]

    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.

15. Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance [6 month]

    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.

16. Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing [During implant procedure.]

    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.

17. Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold [6 month]

    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.

18. Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance [6 month]

    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.

19. Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing [6 month]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Pasadena	California	United States
2		Sacramento	California	United States
3		Atlantis	Florida	United States
4		Atlanta	Georgia	United States
5		Hinsdale	Illinois	United States
6		Davenport	Iowa	United States
7		Kansas City	Kansas	United States
8		Lexington	Kentucky	United States
9		Baton Rouge	Louisiana	United States
10		Saint Louis Park	Minnesota	United States
11		Saint Paul	Minnesota	United States
12		Liverpool	New York	United States
13		New York	New York	United States
14		Durham	North Carolina	United States
15		Portland	Oregon	United States
16		York	Pennsylvania	United States
17		Nashville	Tennessee	United States
18		Austin	Texas	United States
19		Morgantown	West Virginia	United States
20		Bendigo		Australia
21		Linz		Austria
22		Calgary	Alberta	Canada
23		Vancouver	British Columbia	Canada
24		Newmarket	Ontario	Canada
25		Montreal	Quebec	Canada
26		Quebec City	Quebec	Canada
27		Aarhus		Denmark
28		Nantes		France
29		Toulouse		France
30		Treviso		Italy
31		Riyadh		Saudi Arabia

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT00853593
• Other Study ID Numbers: 116
• First Posted: Mar 2, 2009
• Last Update Posted: Feb 18, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: heart failure; cardiac pacing; cardiac resynchronization therapy; left ventricular lead
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects successfully implanted with a Model 4396 LV lead.
Period Title: Overall Study
STARTED	197
Implant Attempted	193
Model 4396 Lead Attempted	164
COMPLETED	152
NOT COMPLETED	45

Baseline Characteristics

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects underwent Model 4396 left ventricular lead implant attempt
Overall Participants	193
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	62 32.1%
>=65 years	131 67.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.6 (10.8)
Sex: Female, Male (Count of Participants)
Female	53 27.5%
Male	140 72.5%
Region of Enrollment (participants) [Number]
France	10 5.2%
United States	125 64.8%
Canada	47 24.4%
Australia	2 1%
Denmark	3 1.6%
Austria	6 3.1%
New York Heart Association (participants) [Number]
Class III	192 99.5%
Class IV	1 0.5%
Race/Ethnicity (participants) [Number]
Asian	2 1%
Black or African American	9 4.7%
Hispanic or Latino	6 3.1%
Native Hawaiian or Pacific Islander	1 0.5%
White/Caucasian	168 87%
Subject chose not to provide information	6 3.1%
Other	1 0.5%
Intrinsic QRS Width (Milliseconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Milliseconds]	154.1 (24.9)
Left Ventricular Ejection Fraction (LVEF) (Percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent]	25.7 (6.5)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects who underwent a Model 4396 left ventricular (LV) lead implant attempt and had a 1 month follow-up visit.

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects who underwent a Model 4396 left ventricular lead implant attempt
Measure Participants	163
Number [participants]	155 80.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Model 4396 LV Lead
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	One sample proportion
	Estimated Value	.951
	Confidence Interval	(1-Sided) 95%; .906 to
	Parameter Dispersion	Type: Value:
	Estimation Comments	The Model 4396 lead will be considered safe if the proportion of subjects free of Model 4396 lead-related complications at one month post-implant is greater than 80% (i.e. the one sided 95% lower confidence bound must be at least 80%).

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Only subjects with pacing thresholds captured at 0.5 ms were included in the analysis.

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with tip electrode capture at 0.5ms at 1-month.
Measure Participants	139
Mean (Standard Deviation) [Volts]	1.6 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Model 4396 LV Lead
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	One sample mean
	Estimated Value	1.6
	Confidence Interval	(1-Sided) 95%; to 1.8
	Parameter Dispersion	Type: Standard Deviation; Value: 1.4
	Estimation Comments

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with ring electrode threshold captured at 0.5 ms at 3-month

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with ring electrode threshold captured at 0.5ms at 3-month.
Measure Participants	121
Mean (Standard Deviation) [Volts]	2.3 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Model 4396 LV Lead
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	One sample mean
	Estimated Value	2.3
	Confidence Interval	(1-Sided) 97.5%; to 2.7
	Parameter Dispersion	Type: Standard Deviation; Value: 2.0
	Estimation Comments

4. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Subjects who underwent Model 4396 LV implant attempt.

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects successfully implanted with a Model 4396 LV lead.
Measure Participants	164
Number [participants]	152 78.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Model 4396 LV Lead
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	One sample proportion
	Estimated Value	.927
	Confidence Interval	(2-Sided) 95%; .887 to .967
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Subjects with successful CS cannulation after an implant attempt.

Arm/Group Title	Any Transvenous LV Lead
Arm/Group Description	Subjects who underwent an implant attempt with successful CS cannulation.
Measure Participants	191
Number [participants]	185 95.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Model 4396 LV Lead
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	One sample proportion
	Estimated Value	.969
	Confidence Interval	(2-Sided) 95%; .944 to .993
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Subjects who underwent an implant attempt.

Arm/Group Title	Any Transvenous LV Lead
Arm/Group Description	Subjects who underwent an implant attempt.
Measure Participants	193
Number [participants]	185 95.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Model 4396 LV Lead
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	One sample proportion
	Estimated Value	.959
	Confidence Interval	(2-Sided) 95%; .930 to .987
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Subjects who underwent an implant attempt.

Arm/Group Title	Any Medtronic LV Lead (Attain Family Lead)
Arm/Group Description	Subjects who underwent an implant attempt.
Measure Participants	193
Number [participants]	183 94.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Model 4396 LV Lead
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	One sample proportion
	Estimated Value	.948
	Confidence Interval	(2-Sided) 95%; .917 to .979
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Subjects successfully implanted with a Model 4396 lead.

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects successfully implanted with a Model 4396 LV lead.
Measure Participants	152
Mean (Standard Deviation) [minutes]	6.1 (9.0)

9. Secondary Outcome

Title	Fluoroscopy Time
Description	The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
Time Frame	During implant procedure.

Outcome Measure Data

Analysis Population Description

Subjects successfully implanted with a Model 4396 lead. Note that one subject's standard fluoroscopy time was not collected and a study deviation was reported.

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects successfully implanted with a Model 4396 LV lead.
Measure Participants	151
Mean (Standard Deviation) [minutes]	20.6 (13.6)

10. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Subjects successfully implanted with a Model 4396 lead. Note that one subject's LV Lead placement time was permanently missing and a study deviation was reported.

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects successfully implanted with a Model 4396 LV lead.
Measure Participants	151
Mean (Standard Deviation) [minutes]	13.9 (16.3)

11. Secondary Outcome

Title	Total Operation Time
Description	Total operation time was defined as time from initial incision to final closure.
Time Frame	During implant procedure.

Outcome Measure Data

Analysis Population Description

Subjects successfully implanted with a Model 4396 lead.

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects successfully implanted with a Model 4396 LV lead.
Measure Participants	152
Mean (Standard Deviation) [minutes]	97.4 (41.3)

12. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Subjects who underwent a Model 4396 left ventricular lead implant attempt.

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Model 4396 lead implant attempts.
Measure Participants	164
Number [participants]	162 83.9%

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects that were implanted with a Model 4396 lead and completed the 1 month visit

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects successfully implanted with a Model 4396 LV lead and completed 1 month visit.
Measure Participants	136
Mean (Standard Deviation) [Volts]	2.4 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Model 4396 LV Lead
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	One sample mean
	Estimated Value	2.4
	Confidence Interval	(1-Sided) 95%; to 2.7
	Parameter Dispersion	Type: Standard Deviation; Value: 1.9
	Estimation Comments

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with tip electrode threshold captured at 0.5 ms at 6 month

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with tip electrode threshold captured at 0.5ms at 6 month.
Measure Participants	128
Mean (Standard Deviation) [Volts]	1.5 (1.3)

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with tip electrode pacing impedance at 6 month

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with tip electrode pacing impedance at 6 month.
Measure Participants	135
Mean (Standard Deviation) [Ohms]	571.2 (155.0)

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with tip electrode R-wave amplitude at 6 month

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with ring electrode R-wave amplitude at 6 month.
Measure Participants	140
Mean (Standard Deviation) [mV]	18.3 (6.4)

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with ring electrode threshold captured at 0.5 ms at 6 month

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with ring electrode threshold captured at 0.5 ms at 6 month.
Measure Participants	121
Mean (Standard Deviation) [Volts]	2.2 (2.0)

18. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with ring electrode pacing impedance at 6 month

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with ring electrode pacing impedance at 6 month.
Measure Participants	134
Mean (Standard Deviation) [Ohms]	544.8 (149.2)

19. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

Subjects with ring electrode R-wave amplitude at implant

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with ring electrode R-wave amplitude at implant.
Measure Participants	140
Mean (Standard Deviation) [mV]	17.6 (6.6)

20. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with bipolar configuration threshold captured at 0.5 ms at 6 month

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with bipolar configuration threshold captured at 0.5ms at 6 month.
Measure Participants	128
Mean (Standard Deviation) [Volts]	2.4 (2.0)

21. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with bipolar configuration pacing impedance at 6 month

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with bipolar configuration pacing impedance at 6 month.
Measure Participants	135
Mean (Standard Deviation) [Ohms]	967.1 (239.2)

22. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Subjects with bipolar configuration electrode R-wave amplitude at 6 month.

Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects with bipolar configuration R-wave amplitude at 6 month.
Measure Participants	140
Mean (Standard Deviation) [mV]	15.0 (7.3)

Adverse Events

Time Frame	Subject enrollment-exit
Adverse Event Reporting Description	Reported Adverse Events (AE) were documented on study case report forms as they occurred. Serious AE: AE that led to death, or led to worse health that resulted in: life-threatening illness or injury; a permanent impairment of a body function; hosp.; medical intervention or surgery to prevent permanent impairment to body structure or body function
Arm/Group Title	Model 4396 LV Lead
Arm/Group Description	Subjects successfully implanted with a Model 4396 LV lead.
All Cause Mortality
	Model 4396 LV Lead
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Model 4396 LV Lead
	Affected / at Risk (%)	# Events
Total	76/197 (38.6%)
Blood and lymphatic system disorders
Anemia	1/197 (0.5%)	1
Hyperkalaemia	1/197 (0.5%)	1
Cardiac disorders
Aneurysm of aortic arch	1/197 (0.5%)	1
Asystole	1/197 (0.5%)	1
Atrial fibrillation	1/197 (0.5%)	1
Atrial fibrillation with rapid ventricular response	1/197 (0.5%)	1
Atrial flutter	3/197 (1.5%)	3
Atrial tachycardia	1/197 (0.5%)	2
Cardiac arrest	2/197 (1%)	2
Congestive heart failure	1/197 (0.5%)	2
Coronary artery disease	2/197 (1%)	2
Coronary artery disease aggravated	1/197 (0.5%)	1
Decompensated heart failure	15/197 (7.6%)	17
Myocardial infarction	1/197 (0.5%)	1
Non ST segment elevation myocardial infarction	1/197 (0.5%)	1
Palpitations	1/197 (0.5%)	1
Sudden cardiac death	2/197 (1%)	2
Triple vessel disease	1/197 (0.5%)	1
Ventricular tachycardia	10/197 (5.1%)	10
Endocrine disorders
Hypothyroidism	1/197 (0.5%)	1
Gastrointestinal disorders
Diarrhea	1/197 (0.5%)	1
Gastrointestinal bleeding	1/197 (0.5%)	1
GI bleed	3/197 (1.5%)	3
Small bowel obstruction	1/197 (0.5%)	1
General disorders
Chest pain	1/197 (0.5%)	1
Chest tenderness	1/197 (0.5%)	1
Fever	1/197 (0.5%)	1
Fever of unknown origin	1/197 (0.5%)	1
Hematoma	1/197 (0.5%)	1
Implant site hematoma	3/197 (1.5%)	3
Multiple organ failure	1/197 (0.5%)	1
Non-cardiac chest pain	1/197 (0.5%)	1
Hepatobiliary disorders
Cholelithiasis	1/197 (0.5%)	1
Infections and infestations
Central line infection	1/197 (0.5%)	1
Diverticulitis	2/197 (1%)	2
Foot infection	1/197 (0.5%)	1
Implant site infection	1/197 (0.5%)	1
Pneumonia	2/197 (1%)	2
Sepsis	1/197 (0.5%)	1
Urinary tract infection	1/197 (0.5%)	1
Injury, poisoning and procedural complications
Device lead issue	1/197 (0.5%)	1
Elevated pacing threshold	3/197 (1.5%)	3
Inadequate lead connection	1/197 (0.5%)	1
Inappropriate phrenic nerve stimulation	2/197 (1%)	2
Laceration of head	1/197 (0.5%)	1
Lead dislodgement	10/197 (5.1%)	11
Loss of capture	2/197 (1%)	2
Twiddler's syndrome	2/197 (1%)	2
Metabolism and nutrition disorders
Insulin hypoglycemia	1/197 (0.5%)	1
Loss of control of diabetes	1/197 (0.5%)	1
Musculoskeletal and connective tissue disorders
Degenerative joint disease	1/197 (0.5%)	1
Gouty arthritis	1/197 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/197 (0.5%)	1
Prostatic hypertrophy	1/197 (0.5%)	1
Nervous system disorders
Cerebrovascular accident	1/197 (0.5%)	1
Herniated disc	1/197 (0.5%)	1
Intracerebral hemorrhage	1/197 (0.5%)	1
Middle cerebral artery stroke	1/197 (0.5%)	1
Near syncope	1/197 (0.5%)	1
Spinal column stenosis	1/197 (0.5%)	1
Syncope	2/197 (1%)	3
Transient ischemic attack (TIA)	1/197 (0.5%)	1
Vertigo	1/197 (0.5%)	1
Psychiatric disorders
Alcoholic withdrawal symptoms	1/197 (0.5%)	1
Renal and urinary disorders
Bladder cancer	1/197 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	2/197 (1%)	2
COPD exacerbation	3/197 (1.5%)	3
Effusion pleural	1/197 (0.5%)	1
Embolism pulmonary	1/197 (0.5%)	1
Pneumothorax	2/197 (1%)	2
Skin and subcutaneous tissue disorders
Allergic reaction	1/197 (0.5%)	1
Cellulitis	3/197 (1.5%)	3
Vascular disorders
Deep venous thrombosis arm	1/197 (0.5%)	1
Embolus	1/197 (0.5%)	1
Femoral artery stenosis	1/197 (0.5%)	1
Hypotension	3/197 (1.5%)	3
Peripheral vascular disease	2/197 (1%)	2
Uncontrolled hypertension	1/197 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Model 4396 LV Lead
	Affected / at Risk (%)	# Events
Total	27/197 (13.7%)
Injury, poisoning and procedural complications
Inappropriate phrenic nerve stimulation	11/197 (5.6%)	15
Inappropriate stimulation of diaphragm	16/197 (8.1%)	20

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.