Heart Failure
Conditions
Brief summary
The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.
Detailed description
This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead. A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide. All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.
Interventions
DEVICEQuartet 1457Q 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
1. Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system: to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure. 2. Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead. 3. Have the 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. 4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion criteria
1. Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt 2. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate 3. Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager. 4. Are pregnant or planning pregnancy in the next 6 months 5. Have a life expectancy of less than 24 months due to any condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Free From LV Lead-related Complications Through 3 Months | 3 months | A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Left Ventricular Lead model Quartet 1457Q
Left Ventricular Lead | 499 |
| Total | 499 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 26 |
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Visit not completed | 173 |
| Overall Study | Withdrawal by Subject | 27 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 72.3 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 491 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 450 Participants |
| Region of Enrollment United States | 499 Participants |
| Sex: Female, Male Female | 194 Participants |
| Sex: Female, Male Male | 305 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 27 / 499 |
| other Total, other adverse events | 56 / 499 |
| serious Total, serious adverse events | 60 / 499 |
Outcome results
Primary
Number of Patients Free From LV Lead-related Complications Through 3 Months
A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.
Time frame: 3 months
Population: The first 94 subjects who underwent an attempted implant of the Quartet 1457Q lead and either completed a 3-month follow-up visit, withdrew from the study or died prior to the 3-month follow-up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Patients Free From LV Lead-related Complications Through 3 Months | 4 Participants |
Comparison: The hypothesis for the endpoint is:~H0: Freedom from LV lead-related complications through 3 months (91 days) ≤ 85% H1: Freedom from LV lead-related complications through 3 months (91 days) \> 85%~A total of 85 subjects were required to have at least 80% power to reject the null hypothesis at the 5% significance level at three months (91 days) post-implant or attempted implant. After accounting for 9% attrition, the required sample size was 94 subjects.p-value: 0.05Log Rank