Overview

This trial is active, not recruiting.

Condition heart failure
Sponsor St. Jude Medical
Start date November 2012
End date August 2015
Trial size 201 participants
Trial identifier NCT01733368, CR-1 2-015-SP-HF

Summary

Optimization and evolution of the patient will be evaluated over 6 months after the implant.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Optimization method
time frame: From implant procedure until 6 months post-implant

Secondary Outcomes

Measure
Safety
time frame: From implant procedure until 6 months post-implant
Percentage of responder patients (structural remodelling)
time frame: 6 Months after implant
Demographic data
time frame: Up to 10 days post-implant
Treated Ventricular Tachycardia (VT) / Ventricular Fibrillation (VF) episodes incidence
time frame: From implant procedure until 6 months post-implant

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient with implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude Medical in the left ventricle. - Patient with an echocardiographic study performed during 1 month prior to the implant and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured - Patients who have granted their informed consent. - Patients above 18 years. Exclusion Criteria: - Patients that have been previously resynchronized. - Patients with aortic stenosis or aortic valve prosthesis - Patients who are or may potentially be pregnant. - Patients with a life expectancy <12 months. - Patients who cannot attend the monitoring visits established by the protocol.

Additional Information

Official title Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
Principal investigator Javier Alzueta, MD
Description Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.