Heart Failure
Conditions
Keywords
heart failure, cardiac pacing, left ventricular lead, cardiac resynchronization therapy
Brief summary
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).
Interventions
DEVICEPacing Lead
implant and follow-up of study device
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* QRS greater than or equal to 120 milliseconds (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. A wide QRS (more than 120) suggests that there is a conduction problem, or block, in the ventricles.) * Left Ventricular Ejection Fraction (EF) less than or equal to 35 percent (Ejection Fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the EF the more blood the ventricle is pumping.) * Subject has moderate to severe heart failure despite medications
Exclusion criteria
* Subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt * Subjects with chest pain or who have had a heart attack within the past month before enrollment in the study * Subjects that have had certain surgeries on their heart within the past three months * Subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Subjects Without a Model 4196 Lead Related Complication) | One Month | A subject who was free of a Model 4196 lead related complication by one month visit. |
| Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode) | One Month | Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\]) |
| Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode) | Three Months | Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Medtronic Left Ventricular Leads (Attain Family) | Implant | All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted |
| Cannulation Time | Implant | Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation. |
| Fluoroscopy Time | Implant | Fluoroscopy time was defined as the total time the fluoroscope was imaging. |
| Model 4196 Lead Placement Time | Implant | Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location. |
| Total Implant Time | Implant | Total implant time was defined as time from initial incision to final closure. |
| Assessment of Lead Handling Characteristics | Implant | Lead handling characteristics assessed as acceptable by physicians |
| Subjects Successfully Implanted With Model 4196 Lead | Implant | A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately. |
| Electrical Performance - Tip Electrode: LV Voltage Threshold | 12-month | Model 4196 lead tip electrode LV voltage threshold |
| Electrical Performance -Tip Electrode: Pacing Impedance | 12-month | Model 4196 lead tip electrode pacing impedance |
| Electrical Performance -Ring Electrode: Sensing | Implant | Model 4196 lead ring electrode R-wave amplitude |
| Electrical Performance - Ring Electrode: LV Voltage Threshold | 12-month | Model 4196 lead ring electrode LV voltage threshold |
| Electrical Performance -Ring Electrode: Pacing Impedance | 12-Month | Model 4196 lead ring electrode pacing impedance |
| Summarize All Adverse Events | Up to 18 months | All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu |
| Electrical Performance - Tip Electrode: Sensing | 12-month | Model 4196 lead tip electrode R-wave amplitude |
| Subjects Successfully Implanted After Cannulation | Implant | A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately. |
| All Left Ventricular Leads | Implant | All left ventricular leads successfully implanted |
Countries
Canada, United States
Participant flow
Pre-assignment details
Total number of patients enrolled after meeting inclusion/exclusion criteria was 190. Total number of patients that received an implant attempt was 186. Total number of patients with a 4196 lead attempt was 177. Total number of patients successfully implanted with a 4196 lead was 170. Some data was not reported and deviations were recorded.
Participants by arm
| Arm | Count |
|---|---|
| 4196 Lead Subjects underwent Model 4196 left ventricular lead implant attempt | 186 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Implant not attempted | 4 |
| Overall Study | Model 4196 lead not attempted | 9 |
| Overall Study | Subjects did not receive a 4196 lead | 7 |
Baseline characteristics
| Characteristic | 4196 Lead |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 129 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants |
| Age Continuous | 69.1 years STANDARD_DEVIATION 11.1 |
| Intrinsic QRS Width | 153.1 Milliseconds STANDARD_DEVIATION 24.1 |
| Left Ventricular Ejection Fraction | 24.2 Percent STANDARD_DEVIATION 6.9 |
| New York Heart Association Class III | 182 Participants |
| New York Heart Association Class IV | 2 Participants |
| New York Heart Association Missing | 2 Participants |
| Race / Ethnicity American Indian or Alaska Native | 1 Participants |
| Race / Ethnicity Asian | 2 Participants |
| Race / Ethnicity Black or African American | 10 Participants |
| Race / Ethnicity Columbian | 1 Participants |
| Race / Ethnicity Hispanic or Latino | 3 Participants |
| Race / Ethnicity Native Hawaiian or Pacific Islander | 1 Participants |
| Race / Ethnicity Sri Lankan | 1 Participants |
| Race / Ethnicity Subject chose not to provide | 6 Participants |
| Race / Ethnicity White | 161 Participants |
| Region of Enrollment Canada | 43 participants |
| Region of Enrollment United States | 143 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 138 Participants |
Outcome results
Primary
Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)
Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])
Time frame: Three Months
Population: Subjects with pacing threshold at ring electrode captured at 0.5 milliseconds (ms) at 3-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode) | 1.9 volts | Standard Deviation 2 |
97.5% CI: [1.9, 2.2]
Primary
Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)
Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])
Time frame: One Month
Population: Subjects with pacing threshold at tip electrode captured at 0.5 milliseconds (ms) at 1-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode) | 1.1 volts | Standard Deviation 0.9 |
95% CI: [1.1, 1.2]
Primary
Safety (Subjects Without a Model 4196 Lead Related Complication)
A subject who was free of a Model 4196 lead related complication by one month visit.
Time frame: One Month
Population: Subjects who underwent a Model 4196 left ventricular (LV) lead implant attempt and completed 1-month visit; or experienced Model 4196 lead related complications by 1-month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4196 Lead | Safety (Subjects Without a Model 4196 Lead Related Complication) | 168 participants |
95% CI: [0.92, 0.955]
Secondary
All Left Ventricular Leads
All left ventricular leads successfully implanted
Time frame: Implant
Population: Subjects who underwent an implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4196 Lead | All Left Ventricular Leads | 181 participants |
95% CI: [0.95, 0.996]
Secondary
All Medtronic Left Ventricular Leads (Attain Family)
All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted
Time frame: Implant
Population: Subjects who underwent an implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4196 Lead | All Medtronic Left Ventricular Leads (Attain Family) | 181 participants |
95% CI: [0.95, 0.996]
Secondary
Assessment of Lead Handling Characteristics
Lead handling characteristics assessed as acceptable by physicians
Time frame: Implant
Population: All available assessments from physicians.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4196 Lead | Assessment of Lead Handling Characteristics | 174 participants |
Secondary
Cannulation Time
Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.
Time frame: Implant
Population: Subjects successfully implanted with a Model 4196 lead.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Cannulation Time | 10.4 minutes | Standard Deviation 4 |
Secondary
Electrical Performance - Ring Electrode: LV Voltage Threshold
Model 4196 lead ring electrode LV voltage threshold
Time frame: 12-month
Population: Subjects with Model 4196 lead implanted and 12-month visit completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Electrical Performance - Ring Electrode: LV Voltage Threshold | 2.0 Volts | Standard Deviation 2 |
Secondary
Electrical Performance -Ring Electrode: Pacing Impedance
Model 4196 lead ring electrode pacing impedance
Time frame: 12-Month
Population: Subjects with Model 4196 lead implanted and completed 12-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Electrical Performance -Ring Electrode: Pacing Impedance | 497.1 Ohms | Standard Deviation 262.9 |
Secondary
Electrical Performance -Ring Electrode: Sensing
Model 4196 lead ring electrode R-wave amplitude
Time frame: Implant
Population: Subjects with Model 4196 lead implanted and with intrinsic R-wave amplitude at implant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Electrical Performance -Ring Electrode: Sensing | 15.4 mV | Standard Deviation 6.9 |
Secondary
Electrical Performance - Tip Electrode: LV Voltage Threshold
Model 4196 lead tip electrode LV voltage threshold
Time frame: 12-month
Population: Subjects with Model 4196 lead implanted and 12-month visit completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Electrical Performance - Tip Electrode: LV Voltage Threshold | 1.2 Volts | Standard Deviation 1 |
Secondary
Electrical Performance -Tip Electrode: Pacing Impedance
Model 4196 lead tip electrode pacing impedance
Time frame: 12-month
Population: Subjects with Model 4196 lead implanted and 12-month visit completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Electrical Performance -Tip Electrode: Pacing Impedance | 508.7 Ohms | Standard Deviation 144.5 |
Secondary
Electrical Performance - Tip Electrode: Sensing
Model 4196 lead tip electrode R-wave amplitude
Time frame: 12-month
Population: Subjects with Model 4196 lead implanted and an intrinsic R-wave available at 12-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Electrical Performance - Tip Electrode: Sensing | 17.0 millivolt (mV) | Standard Deviation 5.9 |
Secondary
Fluoroscopy Time
Fluoroscopy time was defined as the total time the fluoroscope was imaging.
Time frame: Implant
Population: Subjects successfully implanted with a Model 4196 lead.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Fluoroscopy Time | 25.2 minutes | Standard Deviation 18.9 |
Secondary
Model 4196 Lead Placement Time
Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.
Time frame: Implant
Population: Subjects successfully implanted with a Model 4196 lead.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Model 4196 Lead Placement Time | 11.9 minutes | Standard Deviation 10 |
Secondary
Subjects Successfully Implanted After Cannulation
A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.
Time frame: Implant
Population: Subjects with successful CS cannulation after an incision was made (implant attempt)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4196 Lead | Subjects Successfully Implanted After Cannulation | 181 participants |
95% CI: [0.974, 1]
Secondary
Subjects Successfully Implanted With Model 4196 Lead
A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.
Time frame: Implant
Population: Subjects who underwent Model 4196 lead implant attempt.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4196 Lead | Subjects Successfully Implanted With Model 4196 Lead | 170 participants |
95% CI: [0.932, 0.989]
Secondary
Summarize All Adverse Events
All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu
Time frame: Up to 18 months
Population: All subjects enrolled into the 4196 study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4196 Lead | Summarize All Adverse Events | 538 adverse events |
Secondary
Total Implant Time
Total implant time was defined as time from initial incision to final closure.
Time frame: Implant
Population: Subjects successfully implanted with a Model 4196 lead.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4196 Lead | Total Implant Time | 117.1 minutes | Standard Deviation 101.5 |