Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 178
- Locations
- 47
- Primary Endpoint
- Freedom From Left Ventricular Lead-Related Complications Through 3 Months
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
- •Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
- •Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria
- •Have had a recent CVA or TIA within three months of enrollment
- •Have a contraindication for an emergency thoracotomy
- •Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
- •Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
- •Have undergone a cardiac transplantation within 40 days of enrollment
- •Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment
- •Are currently participating in a clinical investigation that includes an active treatment arm
- •Are pregnant or planning to become pregnant during the duration of the study
- •Have a life expectancy of less than 6 months due to any condition
- •Are less than 18 years of age
- •Are unable to comply with the follow up schedule
Arms & Interventions
CRT-D and LV lead
Intervention: CRT-D and LV lead (Quartet™ lead and Promote Q® device system) (Device)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported