Heart Failure
Conditions
Keywords
Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart failure, ICD
Brief summary
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.
Detailed description
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.
Interventions
DEVICEQuickFlex Micro Model 1258T Left Heart Lead
Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Approved indication for CRT-D system
Exclusion criteria
* Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment * Previous left ventricular (LV) lead implant * Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Left Ventricular Lead-related Complications | 3 months | 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. |
| Percentage of Successful Left Ventricular Lead Implants | 3 months | 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. |
| Left Ventricular Bipolar Pacing Capture Threshold (Volts) | 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 86 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Unsuccessful Implant | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | QuickFlex Micro 1258T Left Heart Lead |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 65 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 71.0 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment United States | 86 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 86 |
| serious Total, serious adverse events | 4 / 86 |
Outcome results
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.
Time frame: 3 months
Population: Analysis was conducted on the 81 patients with a successful left ventricular lead implant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QuickFlex Micro 1258T Left Heart Lead | Freedom From Left Ventricular Lead-related Complications | 100 percent of participants |
Comparison: The objective performance criteria established for freedom from left ventricular lead related complications at 3 months was greater than 80%. At least 80% of the patients were required to be free from left venticular lead related complications at 3 months.Kaplan-Meier Survival Analysis
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| QuickFlex Micro 1258T Left Heart Lead | Left Ventricular Bipolar Pacing Capture Threshold (Volts) | 1.1 volts | Standard Deviation 0.3 |
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.
Time frame: 3 months
Population: All patients with an implant or attempted implant were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QuickFlex Micro 1258T Left Heart Lead | Percentage of Successful Left Ventricular Lead Implants | 94 percentage of participants |
Wilson score interval method