Quartet Lead and Resynchronization Therapy Options

NCT ID: NCT01295840

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CRT therapy

Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Group Type: NO_INTERVENTION

Cardiac Resynchronization Therapy Defibrillator

Intervention Type: DEVICE

Cardiac Resynchronization Therapy Defibrillator

Interventions

Cardiac Resynchronization Therapy Defibrillator

Cardiac Resynchronization Therapy Defibrillator

Intervention Type: DEVICE

Other Intervention Names

Promote Q. Model; Promote Quadra™.; Quartet®: Tetrapolar left ventricular lead. Model 1458Q.

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.

8. Patients who are unable to provide written informed consent

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Francisco Javier Alzueta Rodríguez, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario Virgen de la Victoria

Locations

Hospital Clínico Universitario Virgen de la Victoria

Málaga, , Spain

Countries

Spain

Other Identifiers

CR 10-046-SP-HF

Identifier Type: -

Identifier Source: org_study_id