Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study (Promote Q)
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|ClinicalTrials.gov Identifier: NCT00990665|
Recruitment Status : Completed
First Posted : October 7, 2009
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||178 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||July 2012|
|Experimental: CRT-D and LV lead||
Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
Promote Q CRT-D and Quartet LV lead
- Freedom From Left Ventricular Lead-Related Complications Through 3 Months [ Time Frame: 3 months ]The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.
- Freedom From System-related Complications Through 3 Months [ Time Frame: 3 Months ]The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.
- The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 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. 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990665
Show 24 Study Locations
|Study Chair:||Gery Tomassoni, MD||Central Baptist Hospital|