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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QuickFlex micro 1258T left heart lead | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuickFlex Micro Model 1258T Left Heart Lead | Device | Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Shipman | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital-University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
All patients were included in the study analysis with the exception of patients who underwent unsuccessful implantation of the 1258T lead system. These patients were followed for a period of 30 days and then were withdrawn from the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | QuickFlex Micro 1258T Left Heart Lead | All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Arkansas Cardiology |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Glendale Memorial Hospital and Medical Center | Glendale | California | 91204 | United States |
| Regional Cardiology Associates | Sacramento | California | 95819 | United States |
| Midwest Heart Foundation | Lombard | Illinois | 60148 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Thoracic Cardiovascular Healthcare Foundation | Lansing | Michigan | 48910 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| EMH Regional Medical Center | Elyria | Ohio | 44035 | United States |
| St. Thomas Hospital | Nashville | Tennessee | 37205 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | QuickFlex Micro 1258T Left Heart Lead | All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was conducted on the 81 patients with a successful left ventricular lead implant. | Posted | Number | 95% Confidence Interval | percent of participants | 3 months |
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| Primary | 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. | All patients with an implant or attempted implant were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months |
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| Primary | 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. | This effectiveness endpoint was carried out on the first 16 patients who had a LV lead bipolar pacing capture threshold measurement at 3 months at 0.5 ms pulse width. This patient cohort is referred to as the "Primary Pacing Capture Threshold Patient Cohort". | Posted | Mean | Standard Deviation | volts | 3 months |
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Data was collected from the time the first patient was enrolled until follow up was completed; a total of 7 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QuickFlex Micro 1258T Left Heart Lead | All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention. | 4 | 86 | 20 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac vein thrombus | Cardiac disorders | Systematic Assessment |
| ||
| Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Right ventricular lead dislodgement/migration | Surgical and medical procedures | Systematic Assessment |
| ||
| Right ventricular lead cardiac perforation | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac vein thrombus | Cardiac disorders | Systematic Assessment |
| ||
| Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| High defibrillation threshold | Cardiac disorders | Systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Systematic Assessment |
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| Left ventricular lead dislodgement/migration | Surgical and medical procedures | Systematic Assessment |
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| Elevated left ventricular pacing threshold | Cardiac disorders | Systematic Assessment |
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| Phrenic Nerve/Diaphragmatic Nerve stimulation | Surgical and medical procedures | Systematic Assessment |
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| Right atrial lead undersensing | Cardiac disorders | Systematic Assessment |
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| Device pocket stimulation | Surgical and medical procedures | Systematic Assessment |
| ||
| Therapy for non-ventricular rhythm | Cardiac disorders | Systematic Assessment |
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| Atrial Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Affairs | St. Jude Medical | (408) 522-6410 | tshipman@sjm.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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