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Optimization and evolution of the patient will be evaluated over 6 months after the implant.
Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Responder Patients (Structural Remodelling) | Structural remodelling is defined as a reduction >15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant. | 6 months after implant |
| Safety Outcomes in CRT Responders and Non-Responders |
| 6 months after implant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector | Response is defined as a reduction >15% in LVESV, measured 6 months after implant. Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads. | 6 months after implant |
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Inclusion Criteria:
Exclusion Criteria:
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Heart failure patients
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| Name | Affiliation | Role |
|---|---|---|
| Javier Alzueta, MD | Hospital ClÃnico Universitario Virgen de la Victoria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Victoria | Málaga | Spain |
No plan
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| ID | Title | Description |
|---|---|---|
| FG000 | Quadripolar Left Ventricular Lead (Quartet Lead) | Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quadripolar Left Ventricular Lead (Quartet Lead) | Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead |
| 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 Responder Patients (Structural Remodelling) | Structural remodelling is defined as a reduction >15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant. | Patients with the 6-month follow-up completed and echocardiographic measurements available | Posted | Count of Participants | Participants | 6 months after implant |
|
|
6 months after CRT implant
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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 | Quadripolar Left Ventricular Lead (Quartet Lead) | Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Calculous Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upgrade of the device to DDD by adding atrial lead | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Javier Alzueta RodrÃguez | Hospital Clinico Universitario Virgen de la Victoria | 951 03 20 00 | jalzueta@telefonica.net |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Number of Responder Patients With Conventional Left Ventricular Pacing Vector |
Response is defined as a reduction >15% in LVESV, measured 6 months after implant. Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads. |
| 6 months after implant |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| New York Heart Association (NYHA) Classification | The NYHA Functional Classification provides a simple way of classifying the extent of heart failure: I Cardiac disease, but no symptoms and no limitation in ordinary physical activity. II Mild symptoms and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. | Count of Participants | Participants |
|
| Cardiovascular Etiology: Ischemic, Non-ischemic | Count of Participants | Participants |
|
| QRS Duration | Mean | Standard Deviation | miliseconds (ms) |
|
| QRS Morphology | Count of Participants | Participants |
|
| Ejection Fraction (EF) | Mean | Standard Deviation | percentage (%) |
|
| Left Ventricular End Systolic Volume (LVESV) | Mean | Standard Deviation | milliliters (ml) |
|
| Participants |
|
|
| Primary | Safety Outcomes in CRT Responders and Non-Responders |
| Patients experiencing clinical safety event prior to the 6-month follow-up visit. | Posted | Count of Participants | Participants | 6 months after implant |
|
|
|
| Secondary | Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector | Response is defined as a reduction >15% in LVESV, measured 6 months after implant. Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads. | Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with non-conventional LV pacing vector | Posted | Count of Participants | Participants | 6 months after implant |
|
|
|
| Secondary | Number of Responder Patients With Conventional Left Ventricular Pacing Vector | Response is defined as a reduction >15% in LVESV, measured 6 months after implant. Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads. | Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with a conventional pacing vector | Posted | Count of Participants | Participants | 6 months after implant |
|
|
|
| 6 |
| 198 |
| 50 |
| 198 |
| 15 |
| 198 |
| Atrial or Ventricular arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Bleeding/Hematoma | Surgical and medical procedures | Non-systematic Assessment |
|
| Cardiac arrest and death | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac Tamponade | Cardiac disorders | Non-systematic Assessment |
|
| Death | Cardiac disorders | Non-systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Exacerbacion of Heart Failulre | Cardiac disorders | Non-systematic Assessment |
|
| Exacerbacion of Heart Failulre and Death | Cardiac disorders | Non-systematic Assessment |
|
| Malignant tumor | General disorders | Non-systematic Assessment |
|
| Musculoskeletal non-cardiac chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myocardial infartion | Cardiac disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhabdomyolysis due to amiodarone and statins treatment | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| stroke | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac perforation | Surgical and medical procedures | Non-systematic Assessment |
|
| Elevated Pacing Thresholds | Product Issues | Non-systematic Assessment |
|
| Infection | Surgical and medical procedures | Non-systematic Assessment |
|
| Lead Dislodgement | Product Issues | Non-systematic Assessment |
|
| Phrenic Nerve/Diaphragmatic/Extracardiac stimulation | Product Issues | Non-systematic Assessment |
|
| Sepsis and Death | Surgical and medical procedures | Non-systematic Assessment |
|
| Shiver and physical discomfort during implant | Surgical and medical procedures | Non-systematic Assessment |
|
| Bleeding/Hematoma | Surgical and medical procedures | Non-systematic Assessment |
|
| carbon dioxide narcosis | Surgical and medical procedures | Non-systematic Assessment |
|
| Coronary sinus dissection | Surgical and medical procedures | Non-systematic Assessment |
|
| Inappropriate ATP | Product Issues | Non-systematic Assessment |
|
| Nause and vomiting | Surgical and medical procedures | Non-systematic Assessment |
|
| Pain in the implant site | Surgical and medical procedures | Non-systematic Assessment |
|
| phrenic nerve/diaphragmatic/extracardiac stimulation | Product Issues | Non-systematic Assessment |
|
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| Deaths & Hospitalizations |
|