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Quartet Lead and Resynchronization Therapy Options

Information source: St. Jude Medical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: Cardiac Resynchronization Therapy Defibrillator (Device)

Phase: Phase 4

Status: Completed

Sponsored by: St. Jude Medical

Official(s) and/or principal investigator(s):
Dr. Francisco Javier Alzueta RodrĂ­guez, PhD, Principal Investigator, Affiliation: Hospital ClĂ­nico Universitario Virgen de la Victoria

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.

Clinical Details

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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: 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.

Secondary outcome:

Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors

Cardiac Output (CO) With Different Configurations at Enrollment

Capture Threshold

Capture Threshold

Number of Vectors With Phrenic Nerve Stimulation (PNS)

Number of Vectors With Phrenic Nerve Stimulation (PNS)

Number of Patients With PNS in All Vectors

Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector

Number of Patients With PNS in All Vectors

Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Hospital Clínico Universitario Virgen de la Victoria, Málaga 29010, Spain
Additional Information

Starting date: January 2011
Last updated: March 5, 2015

Page last updated: August 23, 2015

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