Heart Failure
Conditions
Brief summary
The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead. Furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.
Detailed description
This is a prospective, non-randomised, multi-centre, national, interventional clinical trial of a medical device. This trial involves two visits: one at the beginning of the study, which will be undertaken in the seven days following implant, and another visit at 6 months after enrollment. It is recommended that the enrollment visit is undertaken as soon as possible after implantation, although the time window allows the timing to be adapted to each centre's standard practice. Resynchronization therapy in those patients suitable for participation in this trial is expected to begin once this enrollment visit has been completed. Once data collection at enrollment visit has been completed, final device programming will be based on each investigator's criteria and will be undertaken following the standard practice of each centre.
Interventions
Cardiac Resynchronization Therapy Defibrillator
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a Cardiac resynchronization Therapy Defibrillator device (CRT-D) and a Quartet® quadripolar electrode from St Jude Medical (used in Single Site Pacing mode) implanted in the left ventricle. 2. Patients who have provided written informed consent 3. Patients who are in sinus rhythm. 4. Patients older than 18 years of age.
Exclusion criteria
1. Patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit. 2. Patients with valvular disease. 3. Patients in functional class New York Heart Association (NYHA) IV 4. Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained. 5. Patients whose device has been changed/upgraded. 6. Pregnant patients. 7. Patients who do not fulfill all the inclusion criteria. 8. Patients who are unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode. | Enrollment visit (in the seven days after implantation of the device) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors | At enrollment | In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors. The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC. |
| Cardiac Output (CO) With Different Configurations at Enrollment | Enrollment visit (in the seven days after implantation of the device) | Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment. |
| Capture Threshold | Enrollment visit (in the seven days after implantation of the device) | Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode. |
| Number of Patients With PNS in All Vectors | At enrollment | To calculate the number of patients that exhibit PNS in all traditional vector |
| Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector | At enrollment | To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector |
| Number of Vectors With Phrenic Nerve Stimulation (PNS) | Enrollment visit (in the seven days after implantation of the device) | Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode. |
Countries
Spain
Participant flow
Recruitment details
The recruitment target is approximately 50 patients. Recruitment will be competitive, and will last for approximately 12 months, plus six months of follow-up. The trial will finish once all the patients have completed the follow-up.
Participants by arm
| Arm | Count |
|---|---|
| No Arms All patient have a Quartet LV lead. No arms. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | No Arms |
|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 9.3 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 12 / 51 |
Outcome results
Primary
Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.
Time frame: Enrollment visit (in the seven days after implantation of the device)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Arms | Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode. | 27 participants |
Secondary
Capture Threshold
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Time frame: Enrollment visit (in the seven days after implantation of the device)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Arms | Capture Threshold | Best Capture Threshold for Traditional vectors | 0.79 volts | Standard Deviation 0.47 |
| No Arms | Capture Threshold | Best Capture Threshold for Non-Traditional vectors | 0.97 volts | Standard Deviation 0.55 |
| No Arms | Capture Threshold | Best Capture Threshold for all vectors | 0.72 volts | Standard Deviation 0.32 |
Secondary
Capture Threshold
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Time frame: 6 months post-implant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Arms | Capture Threshold | Best Capture Threshold for Traditional vectors | 0.96 volts | Standard Deviation 0.54 |
| No Arms | Capture Threshold | Best Capture Threshold for Non-Traditional vectors | 1.21 volts | Standard Deviation 0.47 |
| No Arms | Capture Threshold | Best Capture Threshold for all vectors | 0.90 volts | Standard Deviation 0.41 |
Secondary
Cardiac Output (CO) With Different Configurations at Enrollment
Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.
Time frame: Enrollment visit (in the seven days after implantation of the device)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Arms | Cardiac Output (CO) With Different Configurations at Enrollment | Non-paced CO | 3.64 L/min | Standard Deviation 0.94 |
| No Arms | Cardiac Output (CO) With Different Configurations at Enrollment | Best CO with Traditional vectors | 4.16 L/min | Standard Deviation 1.12 |
| No Arms | Cardiac Output (CO) With Different Configurations at Enrollment | Best CO with All vectors available in Quartet lead | 4.33 L/min | Standard Deviation 1.12 |
Secondary
Number of Patients With PNS in All Vectors
To calculate the number of patients that exhibit PNS in all traditional vector
Time frame: At enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Arms | Number of Patients With PNS in All Vectors | 8 participants |
Secondary
Number of Patients With PNS in All Vectors
To calculate the number of patients that exhibit PNS in all traditional vector
Time frame: At 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Arms | Number of Patients With PNS in All Vectors | 7 participants |
Secondary
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector
Time frame: At 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Arms | Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector | 5 participants |
Secondary
Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector
Time frame: At enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Arms | Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector | 7 participants |
Secondary
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Time frame: Enrollment visit (in the seven days after implantation of the device)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No Arms | Number of Vectors With Phrenic Nerve Stimulation (PNS) | Number of Traditional vectors with PNS | 51 number of vectors |
| No Arms | Number of Vectors With Phrenic Nerve Stimulation (PNS) | Number of Non-Traditional vectors with PNS | 69 number of vectors |
| No Arms | Number of Vectors With Phrenic Nerve Stimulation (PNS) | Number of Total vectors with PNS | 120 number of vectors |
Secondary
Number of Vectors With Phrenic Nerve Stimulation (PNS)
Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied. Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.
Time frame: At 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No Arms | Number of Vectors With Phrenic Nerve Stimulation (PNS) | Number of Traditional vectors with PNS | 49 number of vectors |
| No Arms | Number of Vectors With Phrenic Nerve Stimulation (PNS) | Number of Non-Traditional vectors with PNS | 69 number of vectors |
| No Arms | Number of Vectors With Phrenic Nerve Stimulation (PNS) | Number of Total vectors with PNS | 118 number of vectors |
Secondary
Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors
In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors. The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC.
Time frame: At enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Arms | Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors | 11.69 percentage of difference of CO | Standard Deviation 11.12 |