NCT01295840

Quartet Lead and Resynchronization Therapy Options

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Cardiac Resynchronization Therapy Defibrillator	Cardiac Resynchronization Therapy Defibrillator

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-04-01
• Completion: 2012-09-01
• First posted: 2011-02-15
• Last updated: 2019-02-20
• Results posted: 2015-03-06

Locations

1 site across 1 country: Spain