CardiomyopathiesFACT-CRTNCT06977217
Factors Associated With Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Non-LBBB ECG Pattern
An observational study of Cardiomyopathies and Heart Failure, run by University of Rochester at 1 site in United States.
Trial summary
Cardiac resynchronization therapy with a defibrillator (CRT-D) in heart failure (HF) patients without left bundle branch block (non-LBBB) has been less beneficial to improve outcomes despite being a guideline indicated therapy, posing a significant treatment challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Heart Failure, Non-left Bundle Branch Block
- What is being tested?
- CRT-D implantation
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 30 Jun 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Study population will include 270 HF patients with non-LBBB and an implanted CRT-D device.
Who may be able to join
- Age 18 years or older (no upper limit)
- Optimal medical therapy for heart failure as established by current guidelines;
- Class IIa or IIb guideline-based indication for CRT-D in non-LBBB patients, including one of the following:
- New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb);
- NYHA class III-IVa HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa);
- NYHA class III-IVa HF, LVEF ≤ 35%, and QRS duration 120- 149 ms (IIb)
- Successful CRT-D generator implant
Who cannot join
- Unable to obtain imaging data from echocardiogram within 1 year prior to CRT-D implant
- Unable to obtain the 20-minute ECG prior to CRT-D implant
- Unable to enroll within 14 days following successful CRT-D generator implant
- Unable or unwilling to follow the study protocol
- Less than 24 months life expectancy at enrollment
- Pregnancy or planned pregnancy in the next 24 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Cardiac resynchronization therapy with a defibrillator (CRT-D) in heart failure (HF) patients without left bundle branch block (non-LBBB) has been less beneficial to improve outcomes despite being a guideline indicated therapy, posing a significant treatment challenge. However, non-LBBB patients with echocardiography response to CRT-D have better outcomes, and pre-implant variables could predict response, identifying patients who benefit the most. In this study, we plan to enroll 270 HF patients with non-LBBB and guideline-indicated CRT-D implantation to validate our prior echocardiography predictor score, and to identify novel ECG and echocardiography predictors using conventional statistics and machine learning analysis. We will also assess the applicability of such a score for clinical outcomes of HF, ventricular arrhythmias, or death.
Read the detailed description
Morbidity, mortality, and health care costs of the treatment of systolic heart failure (HF) are rapidly increasing. Cardiac resynchronization therapy with a defibrillator (CRT-D) is cost-effectively reducing HF events and death in HF patients with a wide QRS and low ejection fraction. However, response to CRT-D is not unequivocally present in all patients, with less benefit in those without the presence of an ECG abnormality, left bundle branch block (non-LBBB), posing a significant treatment challenge.
Because of the conflicting and limited data on response to CRT-D in this cohort, it is possible that we currently treat a large proportion of HF patients with non-LBBB who have limited or no benefit from the device. Therefore, better selection of patients for this expensive therapy is warranted. One of our recent studies suggested a clinical benefit in patients with non-LBBB and marked echocardiography response, and identified predictors. However, there is a need to prospectively validate these predictors of echocardiography response to CRT-D in non-LBBB in this hard-to-treat patient population, and identify potential novel ECG and echocardiography predictors, utilizing novel statistical methods of machine learning. We propose a prospective, observational, single-arm study in a currently guideline-indicated cohort to validate and identify predictors of echocardiography response to CRT-D, including novel ECG and echocardiography markers, and to assess subsequent clinical outcomes in 270 HF patients with an implanted CRT-D and non-LBBB ECG pattern.
The primary aim of the study is to prospectively validating our previously identified clinical predictors of echocardiography response to CRT-D in HF patients with non-LBBB that could enable better patient selection.
Our secondary aim is to identify the incremental value of novel ECG and echocardiography variables to predict echocardiography response to CRT-D in non-LBBB patients, including ECG variables of sum absolute QRST integral and ventricular electrical activation delay, and echocardiography-derived variables of left ventricular dyssynchrony and contractility. Then we will apply the developed predictive model to prospectively identify non-LBBB patients with CRT-D at a risk of heart failure, ventricular arrhythmias, or death. Tertiary aim is to identify novel ECG and echocardiography predictors of response in non-LBBB using machine learning analysis.
Study population will include 270 HF patients with non-LBBB and an implanted CRT-D with 6 months echocardiography follow-up analyzed by an echocardiography core lab, and assessing clinical outcomes of heart failure, ventricular arrhythmias, or death.
- Conditions
- Cardiomyopathies, Heart Failure, Non-left Bundle Branch Block, Cardiac Resynchronization Therapy
- Being tested
- CRT-D implantation
- Keywords
- Cardiomyopathies, Heart Failure, Non-left bundle branch block, Cardiac Resynchronization Therapy
- Medical subject headings
- Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-D implantationProcedure or surgery
Cardiac resynchronization therapy with a defibrillator (CRT-D). This combination device uses a pacemaker and an implantable cardioverter-defibrillator (ICD). It may be recommended for people with heart failure who also have a risk of sudden cardiac death. It can find dangerous heart rhythms and correct them. It can pace the heartbeat or shock the heart out of a dangerous heart rhythm.
What is being measured
The primary outcome is the main question the study is designed to answer.
LVESV improvement
The primary endpoint of the study is a 25% or greater reduction in LV end-systolic volume 12 months after CRT-D implantation in HF patients with non-LBBB, analyzed by the central echocardiography core laboratory. Echocardiography outcomes will be assessed by sonographers blinded to patient characteristics or clinical outcomes to avoid bias.
Measured: 12 months
Secondary outcomes (1)
HF or death or VT or VF
Secondary endpoints will include the composite of heart failure, death, and device detected ventricular tachycardia or ventricular fibrillation to account for all types of adverse outcomes in HF patients with CRT-D.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start21 Mar 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Kutyifa, University of Rochester
- Investigators
- Valentina Kutyifa, MD, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977217
- Sponsor's protocol ID
- STUDY00006153
- Acronym
- FACT-CRT
- Status last verified
- Jun 2026
- First submitted
- 8 May 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Non-LBBB ECG Pattern
- ClinicalTrials.gov ID
- NCT06977217
- Acronym / sponsor ID
- FACT-CRT / STUDY00006153
- Conditions
- Cardiomyopathies, Heart Failure, Non-left Bundle Branch Block, Cardiac Resynchronization Therapy
- Keywords
- Cardiomyopathies, Heart Failure, Non-left bundle branch block, Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiac resynchronization therapy with a defibrillator (CRT-D) in heart failure (HF) patients without left bundle branch block (non-LBBB) has been less beneficial to improve outcomes despite being a guideline indicated therapy, posing a significant treatment challenge. However, non-LBBB patients with echocardiography response to CRT-D have better outcomes, and pre-implant variables could predict response, identifying patients who benefit the most. In this study, we plan to enroll 270 HF patients with non-LBBB and guideline-indicated CRT-D implantation to validate our prior echocardiography predictor score, and to identify novel ECG and echocardiography predictors using conventional statistics and machine learning analysis. We will also assess the applicability of such a score for clinical outcomes of HF, ventricular arrhythmias, or death.
Detailed description
Morbidity, mortality, and health care costs of the treatment of systolic heart failure (HF) are rapidly increasing. Cardiac resynchronization therapy with a defibrillator (CRT-D) is cost-effectively reducing HF events and death in HF patients with a wide QRS and low ejection fraction. However, response to CRT-D is not unequivocally present in all patients, with less benefit in those without the presence of an ECG abnormality, left bundle branch block (non-LBBB), posing a significant treatment challenge.
Because of the conflicting and limited data on response to CRT-D in this cohort, it is possible that we currently treat a large proportion of HF patients with non-LBBB who have limited or no benefit from the device. Therefore, better selection of patients for this expensive therapy is warranted. One of our recent studies suggested a clinical benefit in patients with non-LBBB and marked echocardiography response, and identified predictors. However, there is a need to prospectively validate these predictors of echocardiography response to CRT-D in non-LBBB in this hard-to-treat patient population, and identify potential novel ECG and echocardiography predictors, utilizing novel statistical methods of machine learning. We propose a prospective, observational, single-arm study in a currently guideline-indicated cohort to validate and identify predictors of echocardiography response to CRT-D, including novel ECG and echocardiography markers, and to assess subsequent clinical outcomes in 270 HF patients with an implanted CRT-D and non-LBBB ECG pattern.
The primary aim of the study is to prospectively validating our previously identified clinical predictors of echocardiography response to CRT-D in HF patients with non-LBBB that could enable better patient selection.
Our secondary aim is to identify the incremental value of novel ECG and echocardiography variables to predict echocardiography response to CRT-D in non-LBBB patients, including ECG variables of sum absolute QRST integral and ventricular electrical activation delay, and echocardiography-derived variables of left ventricular dyssynchrony and contractility. Then we will apply the developed predictive model to prospectively identify non-LBBB patients with CRT-D at a risk of heart failure, ventricular arrhythmias, or death. Tertiary aim is to identify novel ECG and echocardiography predictors of response in non-LBBB using machine learning analysis.
Study population will include 270 HF patients with non-LBBB and an implanted CRT-D with 6 months echocardiography follow-up analyzed by an echocardiography core lab, and assessing clinical outcomes of heart failure, ventricular arrhythmias, or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include 270 HF patients with non-LBBB and an implanted CRT-D device.
Key inclusion criteria (7 listed)
- Age 18 years or older (no upper limit)
- Optimal medical therapy for heart failure as established by current guidelines;
- Class IIa or IIb guideline-based indication for CRT-D in non-LBBB patients, including one of the following:
- New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb);
- NYHA class III-IVa HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa);
Key exclusion criteria (6 listed)
- Unable to obtain imaging data from echocardiogram within 1 year prior to CRT-D implant
- Unable to obtain the 20-minute ECG prior to CRT-D implant
- Unable to enroll within 14 days following successful CRT-D generator implant
- Unable or unwilling to follow the study protocol
- Less than 24 months life expectancy at enrollment
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 |
|---|---|---|
| CRT-D implantationCardiac resynchronization therapy with a defibrillator (CRT-D). This combination device uses a pacemaker and an implantable cardioverter-defibrillator (ICD). It may be recommended for people with heart failure who also have a risk of sudden cardiac death. It can find dangerous heart rhythms and correct them. It can pace the heartbeat or shock the heart out of a dangerous heart rhythm. | Procedure or surgery | – |
Primary outcome
LVESV improvement
Time frame: 12 months
The primary endpoint of the study is a 25% or greater reduction in LV end-systolic volume 12 months after CRT-D implantation in HF patients with non-LBBB, analyzed by the central echocardiography core laboratory. Echocardiography outcomes will be assessed by sonographers blinded to patient characteristics or clinical outcomes to avoid bias.
1 secondary outcome
HF or death or VT or VF
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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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.
Valentina Kutyifa, MD, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Heart Failure, run by University of Rochester 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
LVESV improvement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.