Clinical trial NCT01295840: Quartet Lead and Resynchronization Therapy Options
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2011-02-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Enrollment visit (in the seven days after implantation of the device)
Secondary outcomes:
measure: Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors
timeFrame: At enrollment
measure: Cardiac Output (CO) With Different Configurations at Enrollment
timeFrame: Enrollment visit (in the seven days after implantation of the device)
measure: Capture Threshold
timeFrame: Enrollment visit (in the seven days after implantation of the device)
measure: Capture Threshold
timeFrame: 6 months post-implant
measure: Number of Vectors With Phrenic Nerve Stimulation (PNS)
timeFrame: Enrollment visit (in the seven days after implantation of the device)
measure: Number of Vectors With Phrenic Nerve Stimulation (PNS)
timeFrame: At 6 months
measure: Number of Patients With PNS in All Vectors
timeFrame: At enrollment
measure: Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
timeFrame: At enrollment
measure: Number of Patients With PNS in All Vectors
timeFrame: At 6 months
measure: Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector
timeFrame: At 6 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Clínico Universitario Virgen de la Victoria
Study officials:
affiliation: Hospital Clínico Universitario Virgen de la Victoria
name: Dr. Francisco Javier Alzueta Rodríguez, PhD
role: PRINCIPAL_INVESTIGATOR
References: