Quartet Lead and Resynchronization Therapy Options (QUARTO)

Abbott

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Device: Cardiac Resynchronization Therapy Defibrillator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01295840

CR 10-046-SP-HF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

CRT therapy

No Intervention group

Description:

Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Treatment:

Device: Cardiac Resynchronization Therapy Defibrillator