Heart Failure
Conditions
Keywords
CRT, Optimization, Responders
Brief summary
Optimization and evolution of the patient will be evaluated over 6 months after the implant.
Detailed description
Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.
Interventions
None listed
Sponsors
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude Medical in the left ventricle. * Patient with an echocardiographic study performed during 1 month prior to the implant and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured * Patients who have granted their informed consent. * Patients above 18 years.
Exclusion criteria
* Patients that have been previously resynchronized. * Patients with aortic stenosis or aortic valve prosthesis * Patients who are or may potentially be pregnant. * Patients with a life expectancy \<12 months. * Patients who cannot attend the monitoring visits established by the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responder Patients (Structural Remodelling) | 6 months after implant | Structural remodelling is defined as a reduction \>15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant. |
| Safety Outcomes in CRT Responders and Non-Responders | 6 months after implant | * Mortality rate, * Rate of cardiovascular hospitalizations and for any cause or * Combined endpoint (death and all-cause hospitalization) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector | 6 months after implant | 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. |
| Number of Responder Patients With Conventional Left Ventricular Pacing Vector | 6 months after implant | 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 198 |
| Total | 198 |
Baseline characteristics
| Characteristic | Quadripolar Left Ventricular Lead (Quartet Lead) |
|---|---|
| Age, Continuous | 66.01 years STANDARD_DEVIATION 10.22 |
| Cardiovascular Etiology: Ischemic, Non-ischemic Ischemic | 80 Participants |
| Cardiovascular Etiology: Ischemic, Non-ischemic Non-ischemic | 118 Participants |
| Ejection Fraction (EF) | 26.87 percentage (%) STANDARD_DEVIATION 7.38 |
| Left Ventricular End Systolic Volume (LVESV) | 155.17 milliliters (ml) STANDARD_DEVIATION 75.1 |
| New York Heart Association (NYHA) Classification NYHA I | 5 Participants |
| New York Heart Association (NYHA) Classification NYHA II | 77 Participants |
| New York Heart Association (NYHA) Classification NYHA III | 111 Participants |
| New York Heart Association (NYHA) Classification NYHA IV | 5 Participants |
| QRS Duration | 168 miliseconds (ms) STANDARD_DEVIATION 22.22 |
| QRS Morphology Interventricular Conduction Delay (IVCD) | 8 Participants |
| QRS Morphology Left Bundle Branch Block (LBBB) | 168 Participants |
| QRS Morphology Right Bundle Branch Block (RBBB) | 20 Participants |
| QRS Morphology Unknown | 2 Participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 198 |
| other Total, other adverse events | 15 / 198 |
| serious Total, serious adverse events | 50 / 198 |
Outcome results
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.
Time frame: 6 months after implant
Population: Patients with the 6-month follow-up completed and echocardiographic measurements available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadripolar Left Ventricular Lead (Quartet Lead) | Number of Responder Patients (Structural Remodelling) | 94 Participants |
Primary
Safety Outcomes in CRT Responders and Non-Responders
* Mortality rate, * Rate of cardiovascular hospitalizations and for any cause or * Combined endpoint (death and all-cause hospitalization)
Time frame: 6 months after implant
Population: Patients experiencing clinical safety event prior to the 6-month follow-up visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quadripolar Left Ventricular Lead (Quartet Lead) | Safety Outcomes in CRT Responders and Non-Responders | All-cause hospitalization | 17 Participants |
| Quadripolar Left Ventricular Lead (Quartet Lead) | Safety Outcomes in CRT Responders and Non-Responders | Death | 0 Participants |
| Quadripolar Left Ventricular Lead (Quartet Lead) | Safety Outcomes in CRT Responders and Non-Responders | Deaths & Hospitalizations | 17 Participants |
| 6-Month CRT Non-Responder | Safety Outcomes in CRT Responders and Non-Responders | All-cause hospitalization | 16 Participants |
| 6-Month CRT Non-Responder | Safety Outcomes in CRT Responders and Non-Responders | Death | 6 Participants |
| 6-Month CRT Non-Responder | Safety Outcomes in CRT Responders and Non-Responders | Deaths & Hospitalizations | 20 Participants |
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.
Time frame: 6 months after implant
Population: Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with a conventional pacing vector
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadripolar Left Ventricular Lead (Quartet Lead) | Number of Responder Patients With Conventional Left Ventricular Pacing Vector | 56 Participants |
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.
Time frame: 6 months after implant
Population: Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with non-conventional LV pacing vector
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadripolar Left Ventricular Lead (Quartet Lead) | Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector | 38 Participants |