CardiomyopathyaCRT-ELSYNCNCT02543281
Adaptive CRT Effect on Electrical Dyssynchrony
A study testing Adaptive cardiac resynchronization therapy and Conventional Cardiac Resynchronization Therapy in people with Cardiomyopathy and Heart Failure, run by Larisa Tereshchenko at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Heart Failure, Left Bundle Branch Block
- What is being tested?
- Adaptive cardiac resynchronization therapy and Conventional Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
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.
- Conditions
- Cardiomyopathy, Heart Failure, Left Bundle Branch Block
- Being tested
- Adaptive cardiac resynchronization therapy, Conventional Cardiac Resynchronization Therapy
- Medical subject headings
- Cardiomyopathies, Heart Failure, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive cardiac resynchronization therapyDevice
Also called aCRT
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.
Conventional Cardiac Resynchronization TherapyDevice
Also called CRT
CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
| Study group | Role | What they receive |
|---|---|---|
| aCRT Off | Active comparator | The adaptive CRT algorithm will be turned off for the CRT device implanted in the patients in this arm. Receives: Device: Conventional Cardiac Resynchronization Therapy |
| aCRT On | Experimental | The adaptive CRT algorithm will be turned on for the CRT device implanted in the patients in this arm. Receives: Device: Adaptive cardiac resynchronization therapy |
| Registry arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 6 months after device implantation
Secondary outcomes (2)
Change in 6-minute Walk Distance 6 Months Post CRT
Change in 6-minute walk distance 6 months post CRT as compared to baseline
Measured: 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).
Measured: baseline and 6 months after device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startApr 2015
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larisa Tereshchenko
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Larisa Tereshchenko, Oregon Health and Science University
- Investigators
- Larisa Tereshchenko, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543281
- Sponsor's protocol ID
- IRB-11299
- Acronym
- aCRT-ELSYNC
- Status last verified
- Mar 2025
- First submitted
- 1 Sep 2015
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Haq KT, Rogovoy NM, Thomas JA, Hamilton C, Lutz KJ, Wirth A, Bender AB, German DM, Przybylowicz R, van Dam P, Dewland TA, Dalouk K, Stecker E, Nazer B, Jessel PM, MacMurdy KS, Zarraga IGE, Beitinjaneh B, Henrikson CA, Raitt M, Fuss C, Ferencik M, Tereshchenko LG. Adaptive Cardiac Resynchronization Therapy Effect on Electrical Dyssynchrony (aCRT-ELSYNC): A randomized controlled trial. Heart Rhythm O2. 2021 Jun 29;2(4):374-381. doi: 10.1016/j.hroo.2021.06.006. eCollection 2021 Aug.
PubMed 34430943
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive CRT Effect on Electrical Dyssynchrony
- ClinicalTrials.gov ID
- NCT02543281
- Acronym / sponsor ID
- aCRT-ELSYNC / IRB-11299
- Conditions
- Cardiomyopathy, Heart Failure, Left Bundle Branch Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Larisa TereshchenkoUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 28 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aCRT Off | Active comparator | Device: Conventional Cardiac Resynchronization TherapyThe adaptive CRT algorithm will be turned off for the CRT device implanted in the patients in this arm. |
| aCRT On | Experimental | Device: Adaptive cardiac resynchronization therapyThe adaptive CRT algorithm will be turned on for the CRT device implanted in the patients in this arm. |
| Registry arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive cardiac resynchronization therapyAlso: aCRTThe 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. | Device | aCRT On |
| Conventional Cardiac Resynchronization TherapyAlso: CRTCRT without the adaptive algorithm works by giving stimulation to both sides of the heart. | Device | aCRT Off |
Primary outcome
Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times.
Time frame: 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.
2 secondary outcomes
Change in 6-minute Walk Distance 6 Months Post CRT
Time frame: baseline and 6 months after device implantation
Change in MLHFQ Total Score
Time frame: baseline and 6 months after device implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34430943Haq KT, Rogovoy NM, Thomas JA, Hamilton C, Lutz KJ, Wirth A, Bender AB, German DM, Przybylowicz R, van Dam P, Dewland TA, Dalouk K, Stecker E, Nazer B, Jessel PM, MacMurdy KS, Zarraga IGE, Beitinjaneh B, Henrikson CA, Raitt M, Fuss C, Ferencik M, Tereshchenko LG. Adaptive Cardiac Resynchronization Therapy Effect on Electrical Dyssynchrony (aCRT-ELSYNC): A randomized controlled trial. Heart Rhythm O2. 2021 Jun 29;2(4):374-381. doi: 10.1016/j.hroo.2021.06.006. eCollection 2021 Aug.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larisa Tereshchenko, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive cardiac resynchronization therapy and Conventional Cardiac Resynchronization Therapy in people with Cardiomyopathy and Heart Failure, run by Larisa Tereshchenko at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times. (time frame: baseline and 6 months after device implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02543281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.