Heart Failure
Conditions
Keywords
heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
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.
Interventions
DEVICEPacing Lead
implant and follow-up of study device
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Fluoroscopy Time | During implant procedure. | The total time the fluoroscope was imaging (not including biplane fluoroscopy time). |
| 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. |
| Total Operation Time | During implant procedure. | Total operation time was defined as time from initial incision to final closure. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Australia, Austria, Canada, Denmark, France, Italy, Saudi Arabia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Model 4396 LV Lead Subjects underwent Model 4396 left ventricular lead implant attempt | 193 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Implant not attempted | 4 |
| Overall Study | Model 4396 lead not attempted | 29 |
| Overall Study | Subjects did not receive a 4396 lead | 12 |
Baseline characteristics
| Characteristic | Model 4396 LV Lead |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 131 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants |
| Age, Continuous | 69.6 years STANDARD_DEVIATION 10.8 |
| Intrinsic QRS Width | 154.1 Milliseconds STANDARD_DEVIATION 24.9 |
| Left Ventricular Ejection Fraction (LVEF) | 25.7 Percent STANDARD_DEVIATION 6.5 |
| New York Heart Association Class III | 192 participants |
| New York Heart Association Class IV | 1 participants |
| Race/Ethnicity Asian | 2 participants |
| Race/Ethnicity Black or African American | 9 participants |
| Race/Ethnicity Hispanic or Latino | 6 participants |
| Race/Ethnicity Native Hawaiian or Pacific Islander | 1 participants |
| Race/Ethnicity Other | 1 participants |
| Race/Ethnicity Subject chose not to provide information | 6 participants |
| Race/Ethnicity White/Caucasian | 168 participants |
| Region of Enrollment Australia | 2 participants |
| Region of Enrollment Austria | 6 participants |
| Region of Enrollment Canada | 47 participants |
| Region of Enrollment Denmark | 3 participants |
| Region of Enrollment France | 10 participants |
| Region of Enrollment United States | 125 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 197 |
| serious Total, serious adverse events | 76 / 197 |
Outcome results
Primary
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.
Time frame: One month
Population: Only subjects with pacing thresholds captured at 0.5 ms were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Efficacy: Distal Tip Electrode Voltage Threshold | 1.6 Volts | Standard Deviation 1.4 |
Primary
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.
Time frame: Three months
Population: Subjects with ring electrode threshold captured at 0.5 ms at 3-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Efficacy: Proximal Ring Voltage Threshold | 2.3 Volts | Standard Deviation 2 |
Primary
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).
Time frame: One month
Population: Subjects who underwent a Model 4396 left ventricular (LV) lead implant attempt and had a 1 month follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Model 4396 LV Lead | Safety (Subjects Without a Model 4396 Lead Related Complication) | 155 participants |
Secondary
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.
Time frame: During implant procedure.
Population: Subjects who underwent a Model 4396 left ventricular lead implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Model 4396 LV Lead | Assessment of Lead Handling Characteristics Reported as Acceptable | 162 participants |
Secondary
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.
Time frame: During implant procedure.
Population: Subjects successfully implanted with a Model 4396 lead.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Cannulation Time | 6.1 minutes | Standard Deviation 9 |
Secondary
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.
Time frame: 6 month
Population: Subjects with bipolar configuration pacing impedance at 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance | 967.1 Ohms | Standard Deviation 239.2 |
Secondary
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.
Time frame: 6 month
Population: Subjects with bipolar configuration electrode R-wave amplitude at 6 month.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing | 15.0 mV | Standard Deviation 7.3 |
Secondary
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.
Time frame: 6 month
Population: Subjects with bipolar configuration threshold captured at 0.5 ms at 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold | 2.4 Volts | Standard Deviation 2 |
Secondary
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.
Time frame: 6 month
Population: Subjects with ring electrode pacing impedance at 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance | 544.8 Ohms | Standard Deviation 149.2 |
Secondary
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.
Time frame: During implant procedure.
Population: Subjects with ring electrode R-wave amplitude at implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing | 17.6 mV | Standard Deviation 6.6 |
Secondary
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.
Time frame: 6 month
Population: Subjects with ring electrode threshold captured at 0.5 ms at 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold | 2.2 Volts | Standard Deviation 2 |
Secondary
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.
Time frame: 6 month
Population: Subjects with tip electrode pacing impedance at 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance | 571.2 Ohms | Standard Deviation 155 |
Secondary
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.
Time frame: 6 month
Population: Subjects with tip electrode R-wave amplitude at 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing | 18.3 mV | Standard Deviation 6.4 |
Secondary
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.
Time frame: 6 month
Population: Subjects with tip electrode threshold captured at 0.5 ms at 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold | 1.5 Volts | Standard Deviation 1.3 |
Secondary
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.
Time frame: 1 month
Population: Subjects that were implanted with a Model 4396 lead and completed the 1 month visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Efficacy: Bipolar Voltage Threshold | 2.4 Volts | Standard Deviation 1.9 |
Secondary
Fluoroscopy Time
The total time the fluoroscope was imaging (not including biplane fluoroscopy time).
Time frame: During implant procedure.
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Fluoroscopy Time | 20.6 minutes | Standard Deviation 13.6 |
Secondary
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.
Time frame: During implant procedure.
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Model 4396 Lead Placement Time | 13.9 minutes | Standard Deviation 16.3 |
Secondary
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.
Time frame: During implant procedure.
Population: Subjects who underwent an implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Model 4396 LV Lead | Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead | 183 participants |
95% CI: [0.917, 0.979]
Secondary
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.
Time frame: During implant procedure.
Population: Subjects who underwent an implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Model 4396 LV Lead | Subjects Successfully Implanted With Any Transvenous LV Lead | 185 participants |
95% CI: [0.93, 0.987]
Secondary
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.
Time frame: During implant procedure.
Population: Subjects with successful CS cannulation after an implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Model 4396 LV Lead | Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation | 185 participants |
95% CI: [0.944, 0.993]
Secondary
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.
Time frame: During implant procedure.
Population: Subjects who underwent Model 4396 LV implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Model 4396 LV Lead | Subjects Successfully Implanted With Model 4396 Lead | 152 participants |
95% CI: [0.887, 0.967]
Secondary
Total Operation Time
Total operation time was defined as time from initial incision to final closure.
Time frame: During implant procedure.
Population: Subjects successfully implanted with a Model 4396 lead.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model 4396 LV Lead | Total Operation Time | 97.4 minutes | Standard Deviation 41.3 |