The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Promote Q CRT-D and Quartet LV lead
University Hospital of Alabama at Birmingham
Birmingham, Alabama, United States
Freedom From Left Ventricular Lead-Related Complications Through 3 Months
The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.
Time frame: 3 months
Freedom From System-related Complications Through 3 Months
The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.
Time frame: 3 Months
The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months.
The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of \<2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).
Time frame: 3 Months
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