Left Ventricular Ejection FractionREINVENTNCT05652218
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
A study testing LB-CRT and BIV-CRT in people with Left Ventricular Ejection Fraction and Heart Failure (HF), run by Inova Health Care Services at 2 sites in United States.
Trial summary
Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide levels among patients with symptomatic HF, LVEF > 35%, and LBBB. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Left Ventricular Ejection Fraction, Heart Failure (HF), Left Bundle-Branch Block
- What is being tested?
- LB-CRT and BIV-CRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2023to 30 Sep 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female aged ≥18 years
- Strict LBBB defined as QRS duration ≥130ms in women and ≥140ms in men, a QS or rS complex in V1 and V2, as well as notching or QRS slurring in mid-QRS in ≥2 contiguous leads.
- NYHA II/III, ambulatory NYHA IV, or NYHA I HF with any prior history of HF symptom decompensation requiring hospitalization, ED visit, or outpatient visit for care with IV diuretic
- LVEF >35% by clinically obtained echocardiogram overread by the study core-lab
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- Demonstration of adequate echocardiographic images to allow for assessment of endpoints
- On a stable guideline directed HF medical regimen
- For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
- Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.
Who cannot join
- Patients with anticipated addition or titration of HF medical therapies (ACE/ARB/ARNI, beta blocker, MRA, SGLT2 inhibitor) during the duration of the study
- Treatment with another investigational drug or other intervention within 3 months
- Current unrevascularized coronary artery disease, unstable angina, acute MI, CABG, or PCI within the past 3 months
- Significant non-functional mitral or aortic valvular disease (severe stenosis or regurgitation)
- Significant structural heart [including hypertrophic cardiomyopathy (septal thickness ≥15 mm) or infiltrative cardiomyopathy (eg. amyloid)]
- Current moderate to severe pulmonary hypertension (right ventricular systolic pressure of ≥40 mmHg)
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- Oxygen dependent chronic lung disease
- Prolonged episodes of AF (>3 days or an AF burden >10%) within the preceding 3 months
- Presence of cardiac pacemaker or implantable cardioverter defibrillator
- Prior mechanical tricuspid valve replacement
- Pregnancy or lactation due to concerns about the effect of radiation from the pacemaker implantation procedure on the fetus
- Known allergic reactions to components of the pacemaker or leads
- Febrile illness within 3 days of trial enrollment
- Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Control Participant Exclusion Criteria: same
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Inova Health System
Falls Church, Virginia, 22042
About this study
Official title: REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT), a Phase I Prospective Randomized Controlled Trial
Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide levels among patients with symptomatic HF, LVEF > 35%, and LBBB.
Read the detailed description
This pilot study will be a multicenter randomized controlled trial involving 20 medically stable outpatients with heart failure (HF), preserved or mildly reduced LVEF (>35%), and LBBB. Patients will undergo implantation of a Medtronic Percepta CRT-P with an atrial lead, left bundle branch area pacing (LBBap) lead, and a LV lead. They will then be randomly allocated in a 1:1 fashion to usual care plus LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1) or usual care plus BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).
- Being tested
- LB-CRT, BIV-CRT
- Medical subject headings
- Heart Failure, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-CRTDevice
LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1)
BIV-CRTDevice
BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group Receives: Device: LB-CRT; Device: BIV-CRT |
| Sequence 2 | Experimental | BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group Receives: Device: LB-CRT; Device: BIV-CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in myocardial performance index (MPI) as compared to Baseline
Myocardial performance index (MPI), a global measure of cardiac performance is defined using tissue Doppler imaging.
Measured: Baseline and 3 month treatment period after each pacing mode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start26 Feb 2023
- Primary completion28 Feb 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Ejection FractionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single arm crossover study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Brett Atwater, MD, Inova Health Care Services
- Investigators
- Brett Atwater, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652218
- Sponsor's protocol ID
- U22-04-4739
- Acronym
- REINVENT
- Status last verified
- May 2026
- First submitted
- 7 Dec 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT), a Phase I Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05652218
- Acronym / sponsor ID
- REINVENT / U22-04-4739
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 26 Feb 2023 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Dec 2022 (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.
Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide levels among patients with symptomatic HF, LVEF > 35%, and LBBB.
Detailed description
This pilot study will be a multicenter randomized controlled trial involving 20 medically stable outpatients with heart failure (HF), preserved or mildly reduced LVEF (>35%), and LBBB. Patients will undergo implantation of a Medtronic Percepta CRT-P with an atrial lead, left bundle branch area pacing (LBBap) lead, and a LV lead. They will then be randomly allocated in a 1:1 fashion to usual care plus LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1) or usual care plus BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- single arm crossover study
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: LB-CRT, Device: BIV-CRTLB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group |
| Sequence 2 | Experimental | Device: LB-CRT, Device: BIV-CRTBiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female aged ≥18 years
- Strict LBBB defined as QRS duration ≥130ms in women and ≥140ms in men, a QS or rS complex in V1 and V2, as well as notching or QRS slurring in mid-QRS in ≥2 contiguous leads.
- NYHA II/III, ambulatory NYHA IV, or NYHA I HF with any prior history of HF symptom decompensation requiring hospitalization, ED visit, or outpatient visit for care with IV diuretic
Key exclusion criteria (15 listed)
- Patients with anticipated addition or titration of HF medical therapies (ACE/ARB/ARNI, beta blocker, MRA, SGLT2 inhibitor) during the duration of the study
- Treatment with another investigational drug or other intervention within 3 months
- Current unrevascularized coronary artery disease, unstable angina, acute MI, CABG, or PCI within the past 3 months
- Significant non-functional mitral or aortic valvular disease (severe stenosis or regurgitation)
- Significant structural heart [including hypertrophic cardiomyopathy (septal thickness ≥15 mm) or infiltrative cardiomyopathy (eg. amyloid)]
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 |
|---|---|---|
| LB-CRTLB-CRT (DDD 60-130, LV lead turned off) (active intervention #1) | Device | Sequence 1, Sequence 2 |
| BIV-CRTBIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2). | Device | Sequence 1, Sequence 2 |
Primary outcome
Change in myocardial performance index (MPI) as compared to Baseline
Time frame: Baseline and 3 month treatment period after each pacing mode
Myocardial performance index (MPI), a global measure of cardiac performance is defined using tissue Doppler imaging.
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 6 May 2026.
- Individual participant dataSharing planned: No
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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.
Brett Atwater, MD principal investigator
Inova Health Care Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LB-CRT and BIV-CRT in people with Left Ventricular Ejection Fraction and Heart Failure (HF), run by Inova Health Care Services at 2 sites 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 10 inclusion and 15 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in myocardial performance index (MPI) as compared to Baseline (time frame: Baseline and 3 month treatment period after each pacing mode). 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 6 May 2026.