An interventional study of Adaptive cardiac resynchronization therapy and Conventional Cardiac Resynchronization Therapy in Cardiomyopathy, Heart Failure and Left Bundle Branch Block, sponsored by Larisa Tereshchenko. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Larisa Tereshchenko · Not applicable, Interventional, and Treatment
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.
553 studies on the registry are indexed under Cardiomyopathies; 152 are open to participants now.
This study's enrollment of 32 is below the median of 51 across 266 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Larisa Tereshchenko is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The adaptive CRT algorithm will be turned off for the CRT device implanted in the patients in this arm.
Device: Conventional Cardiac Resynchronization Therapy
The adaptive CRT algorithm will be turned on for the CRT device implanted in the patients in this arm.
Device: Adaptive cardiac resynchronization therapy
Participants who are not eligible for the randomization because of the implantation of the device that is not capable of delivering aCRT. The team of clinical care providers makes such a clinical decision acting in the patient's best interests.
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.
Also known as: aCRT
CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
Also known as: CRT
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
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
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
| Milestone | aCRT Off | aCRT On | Registry |
|---|---|---|---|
| Started | 15 | 12 | 5 |
| Completed | 15 | 12 | 4 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
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.
| ms | aCRT Off | aCRT On | 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. | 21.4 (-30.0 to 49.9) | 18.9 (4.3 to 29.2) | 6.0 (-8.0 to 11.6) |
Change in 6-minute walk distance 6 months post CRT as compared to baseline
| m | aCRT Off | aCRT On | Registry |
|---|---|---|---|
| Change in 6-minute Walk Distance 6 Months Post CRT | 18 (-12 to 41) | -19 (-76 to 57) | 141 (66 to 215) |
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).
| units on a scale | aCRT Off | aCRT On | Registry |
|---|---|---|---|
| Change in MLHFQ Total Score | -20 (-30 to -4) | -7 (-15 to 0.5) | -28 (-43 to -9) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| aCRT Off | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| aCRT On | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Registry | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | aCRT Off | aCRT On | Registry | Total |
|---|---|---|---|---|
| Mean | 65.3 ± 12.2 | 62.2 ± 10.3 | 67.3 ± 13.6 | 64.4 ± 11.5 |
| Sex: Female, Male(Participants) | aCRT Off | aCRT On | Registry | Total |
|---|---|---|---|---|
| Female | 5 | 4 | 2 | 11 |
| Male | 10 | 8 | 3 | 21 |
| Race/Ethnicity, Customized(Participants) | aCRT Off | aCRT On | Registry | Total |
|---|---|---|---|---|
| Race and Ethnicity — Non-Hispanic White | 15 | 11 | 5 | 31 |
| Race and Ethnicity — Non-White or Hispanic | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | aCRT Off | aCRT On | Registry | Total |
|---|---|---|---|---|
| United States | 15 | 12 | 5 | 32 |
| Left Ventricular Ejection Fraction(Percentage of Left Ventricular EF) | aCRT Off | aCRT On | Registry | Total |
|---|---|---|---|---|
| Mean | 26 ± 8.6 | 29.7 ± 7.5 | 32.3 ± 6.4 | 28.4 ± 8.0 |
| Ischemic cardiomyopathy(Participants) | aCRT Off | aCRT On | Registry | Total |
|---|---|---|---|---|
| Ischemic cardiomyopathy | 9 | 5 | 3 | 17 |
| Non-ischemic cardiomyopathy | 6 | 7 | 2 | 15 |
| QRS duration(ms) | aCRT Off | aCRT On | Registry | Total |
|---|---|---|---|---|
| Mean | 151.3 ± 24.3 | 160.6 ± 19.0 | 153.1 ± 20.9 | 155.1 ± 20.9 |
| Left Bundle Branch Block(Participants) | aCRT Off | aCRT On | Registry | Total |
|---|---|---|---|---|
| Left Bundle Branch Block (strict criteria) | 1 | 4 | 0 | 5 |
| Non - Left Bundle Branch Block | 14 | 8 | 5 | 27 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Larisa Tereshchenko