Heart Failure
Conditions
Keywords
Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart failure
Brief summary
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.
Detailed description
The primary endpoints of the study are: * Freedom from LV lead-related complications at 5 years * LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 years
Interventions
DEVICEImplantation of a QuickFlex® μ Model 1258T LV Lead
Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (IDE) study * Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion criteria
* Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin * Have a life expectancy of less than 5 years due to any condition * Be less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Alive and Without a Left Ventricular Lead-related Complication | 5 years | Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol). |
| Left Ventricular Bipolar Pacing Capture Threshold | 5 years | Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up |
Countries
United States
Participant flow
Recruitment details
Per the clinical investigation protocol, IDE subjects (n=54) who did not consent to roll over into the post approval study (PAS) at sites participating in the post approval study, were included in primary endpoint analyses. Since these subjects are not enrolled into the PAS, they are not reflected in the participant flow.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Implanted With a New QuickFlex μ Lead Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years. | 1,930 |
| Total | 1,930 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 542 |
| Overall Study | Did not complete final visit | 27 |
| Overall Study | Non-death withdrawal | 438 |
| Overall Study | Unsuccessful implant | 80 |
Baseline characteristics
| Characteristic | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Age, Continuous | 68.7 years STANDARD_DEVIATION 11.2 |
| Cardiomyopathy Ischemic | 1131 Participants |
| Cardiomyopathy Non-ischemic | 799 Participants |
| Intrinsic QRS duration | 152.0 ms STANDARD_DEVIATION 25.2 |
| Left Ventricular Ejection Fraction | 25.1 Percent of blood ejected STANDARD_DEVIATION 7.6 |
| New York Heart Association (NYHA) Classification at Baseline Class I | 19 Participants |
| New York Heart Association (NYHA) Classification at Baseline Class II | 175 Participants |
| New York Heart Association (NYHA) Classification at Baseline Class III | 1672 Participants |
| New York Heart Association (NYHA) Classification at Baseline Class IV | 61 Participants |
| New York Heart Association (NYHA) Classification at Baseline Unknown | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 197 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 67 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Other | 8 Participants |
| Race/Ethnicity, Customized White | 1646 Participants |
| Region of Enrollment United States | 1930 participants |
| Sex: Female, Male Female | 529 Participants |
| Sex: Female, Male Male | 1401 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 542 / 1,930 |
| other Total, other adverse events | 512 / 1,930 |
| serious Total, serious adverse events | 258 / 1,930 |
Outcome results
Primary
Left Ventricular Bipolar Pacing Capture Threshold
Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up
Time frame: 5 years
Population: Subjects included in this analysis are only those who have left ventricular bipolar pacing capture threshold values reported a the 5-year visit. Of the 843 who completed the 5 year visit, only 774 had analzable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Implanted With a New QuickFlex μ Lead | Left Ventricular Bipolar Pacing Capture Threshold | 2.04 Volts | Standard Deviation 1.6 |
Primary
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).
Time frame: 5 years
Population: The analysis population for Primary Endpoint #1 includes newly enrolled and IDE rollover subjects with an attempted implant of the QuickFlex μ LV lead (n=1,930) and subjects from the IDE sites that agreed to participate in the post-approval study, but did not consent to rollover into the post-approval study (n=54), for a total of 1,984 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects Implanted With a New QuickFlex μ Lead | Percent of Participants Alive and Without a Left Ventricular Lead-related Complication | 1902 Participants |