Cardiac Arrhythmias, Heart Failure
Conditions
Brief summary
The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with cardiac resynchronization therapy device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram optimization methods).
Detailed description
* This is a prospective, double-blinded, multicenter, randomized study * Patient could be enrolled up to 2 weeks post CRT-D implant and are followed for 12 months post implant with follow-up visits at 3, 6, 9 and 12 months * Patients will be randomized at enrollment to either Group 1 (QuickOpt Group) or Group 2 (Control Group). * Group 1 - The patient's device is programmed to sequential biventricular pacing mode with AV/PV and VV delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3 month, 6 month, 9 month, 12 month and at any unscheduled follow-up visits. * Group 2 - The patient's device is programmed to either simultaneous or sequential BiV pacing mode as per physician's discretion. The AV/PV and inter-ventricular (VV) delays could be programmed empirically or optimized using any non-IEGM based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post implant. Any AV/PV and VV delay optimizations performed after 4 weeks post implant in Group 2 patients will be considered protocol deviations.
Interventions
DEVICEControl
Empiric programming or one-time optimization using a non-IEGM method.
DEVICEQuickOpt
Frequent optimization using QuickOpt to optimize AV/PV and VV delays.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient meets current CRT-D indications and be implanted with a St. Jude Medical (SJM) CRT¬D device with VV timing and a compatible lead system. * Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath. * Patient has the ability to independently comprehend and complete a QOL questionnaire.
Exclusion criteria
* Patient has an epicardial ventricular lead system. * Patient has the ability to walk ≥ 450 meters in 6 minutes * Patient has limited intrinsic atrial activity (≤ 40 bpm). * Patient has persistent or permanent atrial fibrillation (AF). * Patient has a 2° or 3° heart block. * Patient's life expectancy is less than 1 year. * Patient is pregnant. * Patient is on IV inotropic agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure Clinical Composite Score | 12 months | The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse. |
Secondary
| Measure | Time frame |
|---|---|
| All-cause, Cardiovascular and Heart Failure Mortality; | 12 months |
| All Cause, Cardiovascular and Heart Failure Hospitalization | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| QuickOpt (Treatment) Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays. | 817 |
| Control Empiric programming or one-time optimization using a non-IEGM method. | 830 |
| Total | 1,647 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | QuickOpt (Treatment) | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 510 Participants | 490 Participants | 1000 Participants |
| Age, Categorical Between 18 and 65 years | 307 Participants | 340 Participants | 647 Participants |
| Age, Continuous | 66.8 years STANDARD_DEVIATION 11 | 66.7 years STANDARD_DEVIATION 11 | 66.7 years STANDARD_DEVIATION 11 |
| Region of Enrollment Australia | 17 participants | 15 participants | 32 participants |
| Region of Enrollment Canada | 32 participants | 35 participants | 67 participants |
| Region of Enrollment Europe | 282 participants | 288 participants | 570 participants |
| Region of Enrollment Middle East | 3 participants | 4 participants | 7 participants |
| Region of Enrollment Southeast Asia | 1 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 482 participants | 487 participants | 969 participants |
| Sex: Female, Male Female | 196 Participants | 238 Participants | 434 Participants |
| Sex: Female, Male Male | 621 Participants | 592 Participants | 1213 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 184 / 816 | 177 / 828 |
| serious Total, serious adverse events | 120 / 816 | 111 / 828 |
Outcome results
Primary
Heart Failure Clinical Composite Score
The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QuickOpt (Treatment) | Heart Failure Clinical Composite Score | Improved | 551 participants |
| QuickOpt (Treatment) | Heart Failure Clinical Composite Score | Unchanged | 76 participants |
| QuickOpt (Treatment) | Heart Failure Clinical Composite Score | Worsened | 189 participants |
| Control | Heart Failure Clinical Composite Score | Unchanged | 86 participants |
| Control | Heart Failure Clinical Composite Score | Improved | 559 participants |
| Control | Heart Failure Clinical Composite Score | Worsened | 183 participants |
Secondary
All Cause, Cardiovascular and Heart Failure Hospitalization
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QuickOpt (Treatment) | All Cause, Cardiovascular and Heart Failure Hospitalization | 294 participants |
| Control | All Cause, Cardiovascular and Heart Failure Hospitalization | 303 participants |
Secondary
All-cause, Cardiovascular and Heart Failure Mortality;
Time frame: 12 months
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QuickOpt (Treatment) | All-cause, Cardiovascular and Heart Failure Mortality; | 44 participants |
| Control | All-cause, Cardiovascular and Heart Failure Mortality; | 42 participants |