An observational study in Heart Failure, sponsored by Abbott Medical Devices. Completed at 77 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-12.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
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.
The primary endpoints of the study are:
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 1,930 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with an approved indication for implantation of a CRT-D system
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead
Also known as: LV pacing lead
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
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
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.
| Milestone | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Started | 1930 |
| Completed | 843 |
| Not completed | 1087 |
| Withdrew: Death | 542 |
| Withdrew: Unsuccessful implant | 80 |
| Withdrew: Non-death withdrawal | 438 |
| Withdrew: Did not complete final visit | 27 |
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).
| Participants | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Percent of Participants Alive and Without a Left Ventricular Lead-related Complication | 1902 |
Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up
| Volts | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Left Ventricular Bipolar Pacing Capture Threshold | 2.04 ± 1.6 |
Collected over Complications and observations post implant through 5 years. Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects Implanted With a New QuickFlex μ Lead | 542/1,930 (28.1%) | 258/1,930 (13.4%) | 512/1,930 (26.5%) |
| Event | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Lead Dislodgement or MigrationInjury, poisoning and procedural complications | 62/1930 |
| RV Lead Dislodgement or MigrationInjury, poisoning and procedural complications | 31/1930 |
| InfectionInfections and infestations | 24/1930 |
| RA Lead Dislodgement or MigrationProduct Issues | 20/1930 |
| Diaphragmatic/Phrenic Nerve StimulationInjury, poisoning and procedural complications | 16/1930 |
| Loss of CaptureProduct Issues | 9/1930 |
| RV Elevated Pacing ThresholdsProduct Issues | 9/1930 |
| Procedure Hematoma/SeromaInjury, poisoning and procedural complications | 9/1930 |
| Elevated Pacing ThresholdsProduct Issues | 8/1930 |
| Premature Battery DepletionProduct Issues | 8/1930 |
| Event | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| LV Lead Elevated Pacing ThresholdsProduct Issues | 214/1930 |
| LV Diaphragmatic/Phrenic Nerve StimulationInjury, poisoning and procedural complications | 145/1930 |
| Procedure Related Hematoma/SeromaInjury, poisoning and procedural complications | 33/1930 |
| System/Pulse Generator Related Therapy For Non-Ventricular RhythmCardiac disorders | 23/1930 |
| LV Loss of CaptureProduct Issues | 19/1930 |
| Abnormal LV Lead Pacing Impedance <= 200 Ω or >= 2000 ΩProduct Issues | 16/1930 |
| Procedure Related Cardiac/Coronary Sinus DissectionInjury, poisoning and procedural complications | 12/1930 |
| RA Lead Related OversensingProduct Issues | 9/1930 |
| RV Lead Related Therapy For Non-Ventricular RhythmCardiac disorders | 6/1930 |
| Other Therapy For Non-Ventricular RhythmCardiac disorders | 6/1930 |
| Age, Continuous(years) | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Mean | 68.7 ± 11.2 |
| Sex: Female, Male(Participants) | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Female | 529 |
| Male | 1401 |
| Race/Ethnicity, Customized(Participants) | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Asian | 8 |
| American Indian or Alaska Native | 2 |
| Black or African American | 197 |
| Hispanic or Latino | 67 |
| Native Hawaiian/Pacific Islander | 2 |
| Other | 8 |
| White | 1646 |
| Region of Enrollment(participants) | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| United States | 1930 |
| Left Ventricular Ejection Fraction(Percent of blood ejected) | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Mean | 25.1 ± 7.6 |
| Intrinsic QRS duration(ms) | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Mean | 152.0 ± 25.2 |
| New York Heart Association (NYHA) Classification at Baseline(Participants) | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Class I | 19 |
| Class II | 175 |
| Class III | 1672 |
| Class IV | 61 |
| Unknown | 3 |
| Cardiomyopathy(Participants) | Subjects Implanted With a New QuickFlex μ Lead |
|---|---|
| Ischemic | 1131 |
| Non-ischemic | 799 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Sep 2010 to primary completion in Sep 2017, 84 months.
Results were first posted in Aug 2019, 1 year 11 months after primary completion.
Of 160 industry-sponsored observational studies under Heart Failure, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 58. This study's 84 months is above that.
Counting every sponsor, half of 825 studies reached it within 40 months; a quarter within 21 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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