QUARTET LEAD AND RESYNCHRONIZATION THERAPY OPTIONS To Investigate the Stimulatory Possibilities Offered by the Different Configurations Available for the Quartet Lead and Their Effect on Haemodynamic and Clinical Response.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Patients who have provided written informed consent
- •Patients who are in sinus rhythm.
- •Patients older than 18 years of age.
Exclusion Criteria
- •Patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit.
- •Patients with valvular disease.
- •Patients in functional class New York Heart Association (NYHA) IV
- •Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained.
- •Patients whose device has been changed/upgraded.
- •Pregnant patients.
- •Patients who do not fulfill all the inclusion criteria.
- •Patients who are unable to provide written informed consent
Arms & Interventions
CRT therapy
Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Intervention: Cardiac Resynchronization Therapy Defibrillator (Device)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Capture Threshold(6 months post-implant)
- Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors(At enrollment)
- Cardiac Output (CO) With Different Configurations at Enrollment(Enrollment visit (in the seven days after implantation of the device))
- Number of Vectors With Phrenic Nerve Stimulation (PNS)(At 6 months)
- Number of Patients With PNS in All Vectors(At 6 months)
- Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector(At 6 months)