Overview

This trial is active, not recruiting.

Conditions postoperative cardiac complication, heart failure,, left ventricular cardiac dysfunction, inappropriate phrenic nerve stimulation, perioperative/postoperative complications
Treatments standard left ventricular (lv) lead, quartet left ventricular (lv) lead
Sponsor St. Jude Medical
Start date November 2011
End date May 2014
Trial size 1062 participants
Trial identifier NCT01510652, CR-11-006-HF-ID

Summary

This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Patients in the Study group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet
quartet left ventricular (lv) lead
Implantation of quadripolar Left ventricular (LV) lead Quartet
(Active Comparator)
Patients in the Control Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)
standard left ventricular (lv) lead
Implantation of standard Left Ventricular (LV) lead

Primary Outcomes

Measure
Lead performance
time frame: 6 months

Secondary Outcomes

Measure
Percentage of Cardiac Resynchronization Therapy responders
time frame: 6 months
Implant duration
time frame: Until completion of implantation procedure

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines - Patients age is 18 years or greater - Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form - Patients must be willing and able to comply with all study requirements Exclusion Criteria: - Patients with a life expectancy <12 months. - Patients who are or may potentially be pregnant. - Patient has suffered any of the following in the 4 weeks prior to enrolment: - Myocardial Infarction (MI) - Coronary Artery Bypass Graft (CABG) - Unstable Angina Pectoris - Patient has primary valvular disease which has not been corrected

Additional Information

Official title More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges
Principal investigator Giuseppe Boriani, Pro.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by St. Jude Medical.