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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT therapy | No Intervention | Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy Defibrillator | Device | Cardiac Resynchronization Therapy Defibrillator |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Francisco Javier Alzueta Rodríguez, PhD | Hospital Clínico Universitario Virgen de la Victoria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Arms | All patient have a Quartet Left Ventricular (LV) lead. No arms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Arms | All patient have a Quartet LV lead. No arms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | Enrollment visit (in the seven days after implantation of the device) |
|
|
6 months period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Arms | All patient have a Quartet LV lead. No arms |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RV lead dislodgment | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Javier Alzueta | Hospital Universitario Virgen de la Victoria | +34 952 64 15 50 | jalzueta@telefonica.net |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| At enrollment |
| 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. | Enrollment visit (in the seven days after implantation of the device) |
| 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. | Enrollment visit (in the seven days after implantation of the device) |
| 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. | 6 months post-implant |
| 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. | Enrollment visit (in the seven days after implantation of the device) |
| 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. | At 6 months |
| Number of Patients With PNS in All Vectors | To calculate the number of patients that exhibit PNS in all traditional vector | At enrollment |
| 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 | At enrollment |
| Number of Patients With PNS in All Vectors | To calculate the number of patients that exhibit PNS in all traditional vector | At 6 months |
| 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 | At 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of difference of CO | At enrollment |
|
|
|
| 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. | Posted | Mean | Standard Deviation | L/min | Enrollment visit (in the seven days after implantation of the device) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | volts | Enrollment visit (in the seven days after implantation of the device) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | volts | 6 months post-implant |
|
|
|
| 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. | Posted | Number | number of vectors | Enrollment visit (in the seven days after implantation of the device) | Number of total vectors | Number of total 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. | Posted | Number | number of vectors | At 6 months | Number of vectors | Number of vectors |
|
|
|
| Secondary | Number of Patients With PNS in All Vectors | To calculate the number of patients that exhibit PNS in all traditional vector | Posted | Number | participants | At enrollment |
|
|
|
| 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 | Posted | Number | participants | At enrollment |
|
|
|
| Secondary | Number of Patients With PNS in All Vectors | To calculate the number of patients that exhibit PNS in all traditional vector | Posted | Number | participants | At 6 months |
|
|
|
| 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 | Posted | Number | participants | At 6 months |
|
|
|
| 12 |
| 51 |
| 0 |
| 51 |
| Dyspnea, angina pectoris, severe LV dysfunction, stent implantation | Cardiac disorders | Systematic Assessment |
|
| Pneumothorax, lung was needled during implantation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| LV lead dislocation | Surgical and medical procedures | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Dyspnea due to renal failure, pulmonary edema, flutter | Cardiac disorders | Systematic Assessment |
|
| Congestive cardiac insufficiency | Cardiac disorders | Systematic Assessment |
|
| Renal insufficiency, cardiogenic shock and flutter | Cardiac disorders | Systematic Assessment |
|
| Fever, infection | Infections and infestations | Systematic Assessment |
|
| Fatigue, hypotension episode | Cardiac disorders | Systematic Assessment |
|
| Atrial fibrillation, cardiovertion | Cardiac disorders | Systematic Assessment |
|
| Dyspnea, acute lung edema after ICD explant and CRT implant Hypoxemia, COPD worsening renal failure | Cardiac disorders | Systematic Assessment |
|
| Cognitive impairment, disorientation, injury from tumoral origin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Renal function worsening | Renal and urinary disorders | Systematic Assessment |
|
| Pain at the pocket of device | Surgical and medical procedures | Systematic Assessment |
|
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|---|---|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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