Heart Failure
Conditions
Brief summary
The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT) responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead placement compared to traditional LV lead placement.
Interventions
PROCEDURE3D echo-guided LV lead placement
Information about left ventricular mechanical dyssynchrony and the location of the site of latest mechanical activation based on RT3DE will be available to the physician from the core lab analysis. This location will be used as the target for optimal LV lead placement.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients will be implanted with an FDA approved St. Jude Medical CRT-D device (i.e. PROMOTE® or newer devices with similar functionality) * Patients will have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D * Patients will receive a new implant or an upgrade from an existing pacemaker or Implantable Cardiovertor Defibrillator with no prior Left Ventricular lead placement * Patients must be in sinus rhythm at the time of enrollment visit and baseline measurements
Exclusion criteria
* Persistent or permanent atrial fibrillation * Heart transplantation * Recent myocardial infarction (\< 90 days) * Contra-indication to contrast agent * Are less than 18 years of age * Are pregnant * Are currently participating in a clinical investigation that includes an active treatment arm * Have a life expectancy of less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate | At 6 month follow-up | The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3D Echo-guided LV Lead Placement The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement. | 43 |
| Control Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position. | 35 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 4 |
Baseline characteristics
| Characteristic | Control | 3D Echo-guided LV Lead Placement | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 25 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 18 Participants | 31 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 11 | 67 years STANDARD_DEVIATION 13 | 67 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 35 participants | 43 participants | 78 participants |
| Sex: Female, Male Female | 9 Participants | 15 Participants | 24 Participants |
| Sex: Female, Male Male | 26 Participants | 28 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 43 | 1 / 35 |
| serious Total, serious adverse events | 0 / 43 | 0 / 35 |
Outcome results
Primary
Responder Rate
The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate.
Time frame: At 6 month follow-up
Population: Patients who completed the 6 month follow-up with implant 3D echo data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3D Echo-guided LV Lead Placement | Responder Rate | 67 percentage of participants |
| Control | Responder Rate | 60 percentage of participants |