Cardiomyopathy, Heart Failure, Left Bundle Branch Block
Conditions
Brief summary
The purpose of this study is to better understand how adaptive cardiac resynchronization therapy (aCRT) might benefit patients. aCRT works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning. CRT without the adaptive algorithm works by giving stimulation to both sides of the heart. aCRT has already been approved by the FDA and is being used in patients now, but it is not clear which patients it should be used in compared to normal CRT. This study will include patients who are already scheduled to get a CRT device. The investigators will then randomize patients to the aCRT study arm or to the CRT study arm. After 6 months, the investigators will assess the electrical activity of the patients' hearts. After this time, the patient and their doctors will be able to decide if they would like to change the type CRT they have been designated.
Interventions
DEVICEAdaptive cardiac resynchronization therapy
The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning.
DEVICEConventional Cardiac Resynchronization Therapy
CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
Sponsors
Larisa Tereshchenko
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has a standard class I or class II indications for CRT-P or CRT-D implantation in accordance with ACC/AHA/HRS guidelines (2012 ACCF/AHA/HRS Focused Update Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities)2.At least 18 years of age at the time of consent * Is willing and able to comply with the protocol
Exclusion criteria
* Chronic atrial arrhythmias defined as: Atrial fibrillation is permanent when it has resisted all attempts to restore sinus rhythm or when the physician and patient decide that no such attempt should be made. * Patient has ever had a previous or has an existing CRT system, ICD, or pacemaker. * GFR \<30ml/min * Patient has had unstable angina, acute myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty within 30 days prior to study enrollment * Patient has primary valvular disease and is indicated for valve repair or replacement * Patient is enrolled in ≥1 concurrent studies that would confound the study results (any other interventional trial) * Patient is pregnant or of childbearing potential and not on a reliable form of birth control. All women of child-bearing potential must undergo a pregnancy test. * Patient status post heart transplant * Patient has been classified as NYHA functional class IV within 3 months prior to study enrollment * concomitant conditions other than cardiac diseases that were associated with a higher likelihood of death during 1 year after enrollment * Patient, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times. | baseline and 6 months after device implantation | LV and RV activation time values were measured on reconstructed epicardial activation maps at baseline and 6 months post-CRT. Positive VEU indicated LV uncoupling (delay) from the RV, whereas negative VEU indicated RV uncoupling (delay) from the LV. Difference in difference (change in VEU from baseline to 6 months post-CRT) is reported as the primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-minute Walk Distance 6 Months Post CRT | baseline and 6 months after device implantation | Change in 6-minute walk distance 6 months post CRT as compared to baseline |
| Change in MLHFQ Total Score | baseline and 6 months after device implantation | Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score 6 months post-CRT as compared to baseline. The total MLHFQ score range from 0 (zero; the best health) to 105 (the worst health). Higher MLHFQ values represent worse health. Negative values of the change in total MLHFQ score mean the total MLHFQ score decreased six months after device implantation compared to baseline (improvement). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| aCRT Off The adaptive CRT algorithm turned off for the CRT device implanted in the patients in this arm.
Conventional Cardiac Resynchronization Therapy: CRT without the adaptive algorithm works by giving stimulation to both sides of the heart. | 15 |
| aCRT On The adaptive CRT algorithm turned on for the CRT device implanted in the patients in this arm.
Adaptive cardiac resynchronization therapy: The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning. | 12 |
| Registry Participants who were not eligible for the randomization because of the implantation of the device that was not capable of delivering aCRT. The team of clinical care providers made such a clinical decision acting in the best interests of a patient. | 5 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | aCRT Off | aCRT On | Registry | Total |
|---|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 12.2 | 62.2 years STANDARD_DEVIATION 10.3 | 67.3 years STANDARD_DEVIATION 13.6 | 64.4 years STANDARD_DEVIATION 11.5 |
| Ischemic cardiomyopathy Ischemic cardiomyopathy | 9 Participants | 5 Participants | 3 Participants | 17 Participants |
| Ischemic cardiomyopathy Non-ischemic cardiomyopathy | 6 Participants | 7 Participants | 2 Participants | 15 Participants |
| Left Bundle Branch Block Left Bundle Branch Block (strict criteria) | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
| Left Bundle Branch Block Non - Left Bundle Branch Block | 14 Participants | 8 Participants | 5 Participants | 27 Participants |
| Left Ventricular Ejection Fraction | 26 Percentage of Left Ventricular EF STANDARD_DEVIATION 8.6 | 29.7 Percentage of Left Ventricular EF STANDARD_DEVIATION 7.5 | 32.3 Percentage of Left Ventricular EF STANDARD_DEVIATION 6.4 | 28.4 Percentage of Left Ventricular EF STANDARD_DEVIATION 8 |
| NYHA Class NYHA Class III (more severe) | 6 Participants | 4 Participants | 1 Participants | 11 Participants |
| NYHA Class NYHA Class II (less severe) | 9 Participants | 8 Participants | 4 Participants | 21 Participants |
| QRS duration | 151.3 ms STANDARD_DEVIATION 24.3 | 160.6 ms STANDARD_DEVIATION 19 | 153.1 ms STANDARD_DEVIATION 20.9 | 155.1 ms STANDARD_DEVIATION 20.9 |
| Race/Ethnicity, Customized Race and Ethnicity Non-Hispanic White | 15 Participants | 11 Participants | 5 Participants | 31 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Non-White or Hispanic | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 15 participants | 12 participants | 5 participants | 32 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 3 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 12 | 0 / 5 |
| other Total, other adverse events | 0 / 15 | 0 / 12 | 0 / 5 |
| serious Total, serious adverse events | 0 / 15 | 0 / 12 | 0 / 5 |
Outcome results
Primary
Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times.
LV and RV activation time values were measured on reconstructed epicardial activation maps at baseline and 6 months post-CRT. Positive VEU indicated LV uncoupling (delay) from the RV, whereas negative VEU indicated RV uncoupling (delay) from the LV. Difference in difference (change in VEU from baseline to 6 months post-CRT) is reported as the primary outcome.
Time frame: baseline and 6 months after device implantation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| aCRT Off | Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times. | 21.4 ms |
| aCRT On | Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times. | 18.9 ms |
| Registry | Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times. | 6.0 ms |
Secondary
Change in 6-minute Walk Distance 6 Months Post CRT
Change in 6-minute walk distance 6 months post CRT as compared to baseline
Time frame: baseline and 6 months after device implantation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| aCRT Off | Change in 6-minute Walk Distance 6 Months Post CRT | 18 m |
| aCRT On | Change in 6-minute Walk Distance 6 Months Post CRT | -19 m |
| Registry | Change in 6-minute Walk Distance 6 Months Post CRT | 141 m |
Secondary
Change in MLHFQ Total Score
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score 6 months post-CRT as compared to baseline. The total MLHFQ score range from 0 (zero; the best health) to 105 (the worst health). Higher MLHFQ values represent worse health. Negative values of the change in total MLHFQ score mean the total MLHFQ score decreased six months after device implantation compared to baseline (improvement).
Time frame: baseline and 6 months after device implantation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| aCRT Off | Change in MLHFQ Total Score | -20 units on a scale |
| aCRT On | Change in MLHFQ Total Score | -7 units on a scale |
| Registry | Change in MLHFQ Total Score | -28 units on a scale |