An interventional study of QuickFlex Micro Model 1258T Left Heart Lead in Heart Failure, sponsored by Abbott Medical Devices. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.
The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device.
Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 86 is above the median of 72 across 3,790 interventional 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.
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Exclusion Criteria:
Device: QuickFlex Micro Model 1258T Left Heart Lead
Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.
Also known as: Model 1258T left heart pacing lead
Freedom From Left Ventricular Lead-related Complications
A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.
Time frame: 3 months
Percentage of Successful Left Ventricular Lead Implants
Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.
Time frame: 3 months
Left Ventricular Bipolar Pacing Capture Threshold (Volts)
The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of \< 3 volts is required to meet this endpoint.
Time frame: 3 months
The study was conducted at 18 investigational centers located in the United States (US). The first patient was enrolled on October 30, 2008 and follow up was completed on May 31, 2009.
| Milestone | QuickFlex Micro 1258T Left Heart Lead |
|---|---|
| Started | 86 |
| Completed | 76 |
| Not completed | 10 |
| Withdrew: Unsuccessful implant | 5 |
| Withdrew: Death | 4 |
| Withdrew: Withdrawal by subject | 1 |
A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.
| percent of participants | QuickFlex Micro 1258T Left Heart Lead |
|---|---|
| Freedom From Left Ventricular Lead-related Complications | 100 (100 to 100) |
Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.
| percentage of participants | QuickFlex Micro 1258T Left Heart Lead |
|---|---|
| Percentage of Successful Left Ventricular Lead Implants | 94 (87 to 100) |
The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of \< 3 volts is required to meet this endpoint.
| volts | QuickFlex Micro 1258T Left Heart Leads |
|---|---|
| Left Ventricular Bipolar Pacing Capture Threshold (Volts) | 1.1 ± 0.3 |
Collected over Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.. Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| QuickFlex Micro 1258T Left Heart Lead | — | 4/86 (4.7%) | 20/86 (23.3%) |
| Event | QuickFlex Micro 1258T Left Heart Lead |
|---|---|
| Cardiac vein thrombusCardiac disorders | 1/86 |
| HematomaSkin and subcutaneous tissue disorders | 1/86 |
| Right ventricular lead dislodgement/migrationSurgical and medical procedures | 1/86 |
| Right ventricular lead cardiac perforationCardiac disorders | 1/86 |
| Event | QuickFlex Micro 1258T Left Heart Lead |
|---|---|
| Phrenic Nerve/Diaphragmatic Nerve stimulationSurgical and medical procedures | 10/86 |
| HematomaSkin and subcutaneous tissue disorders | 4/86 |
| High defibrillation thresholdCardiac disorders | 3/86 |
| Therapy for non-ventricular rhythmCardiac disorders | 3/86 |
| Cardiac vein thrombusCardiac disorders | 1/86 |
| HypotensionCardiac disorders | 1/86 |
| Left ventricular lead dislodgement/migrationSurgical and medical procedures | 1/86 |
| Elevated left ventricular pacing thresholdCardiac disorders | 1/86 |
| Right atrial lead undersensingCardiac disorders | 1/86 |
| Device pocket stimulationSurgical and medical procedures | 1/86 |
| Age, Categorical(Participants) | QuickFlex Micro 1258T Left Heart Lead |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 21 |
| >=65 years | 65 |
| Age, Continuous(years) | QuickFlex Micro 1258T Left Heart Lead |
|---|---|
| Mean | 71.0 ± 11.3 |
| Sex: Female, Male(Participants) | QuickFlex Micro 1258T Left Heart Lead |
|---|---|
| Female | 29 |
| Male | 57 |
| Region of Enrollment(participants) | QuickFlex Micro 1258T Left Heart Lead |
|---|---|
| United States | 86 |
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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