Heart Failure
Conditions
Keywords
CRT, Heart Failure, LV Leads
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.
Interventions
DEVICECRT-D and LV lead (Quartet™ lead and Promote Q® device system)
Promote Q CRT-D and Quartet LV lead
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Left Ventricular Lead-Related Complications Through 3 Months | 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 | 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. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CRT-D and LV Lead CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead | 178 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 29 |
| Overall Study | Heart Transplant | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | System Explant | 3 |
| Overall Study | Unsuccessful Implant | 8 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | CRT-D and LV Lead |
|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 11 |
| New York Heart Association Class Class III | 175 participants |
| New York Heart Association Class Class IV | 3 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 140 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 76 / 178 |
| serious Total, serious adverse events | 0 / 178 |
Outcome results
Primary
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
Population: Patients implanted with a Promote Q CRT-D device and Quartet LV lead.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT-D and LV Lead | Freedom From Left Ventricular Lead-Related Complications Through 3 Months | 96 percentage probability |
Primary
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
Population: Participants implanted with a Promote Q CRT-D device and Quartet LV lead.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT-D and LV Lead | Freedom From System-related Complications Through 3 Months | 92 percentage probability |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRT-D and LV Lead | The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months. | 79.2 percentage of participants |
| Patients Per Complete Case Analysis | The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months. | 83.3 percentage of participants |