REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence 1 LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group |
Device: LB-CRT
LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1)
Device: BIV-CRT
BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).
|
| Experimental: Sequence 2 BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group |
Device: LB-CRT
LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1)
Device: BIV-CRT
BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).
|
Outcome Measures
Primary Outcome Measures
- Change in myocardial performance index (MPI) as compared to Baseline [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Male or female aged ≥18 years
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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.
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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
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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
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On a stable guideline directed HF medical regimen
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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
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Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.
Exclusion Criteria:
-
Patients with anticipated addition or titration of HF medical therapies (ACE/ARB/ARNI, beta blocker, MRA, SGLT2 inhibitor) during the duration of the study
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Treatment with another investigational drug or other intervention within 3 months
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Current unrevascularized coronary artery disease, unstable angina, acute MI, CABG, or PCI within the past 3 months
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Significant non-functional mitral or aortic valvular disease (severe stenosis or regurgitation)
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Significant structural heart [including hypertrophic cardiomyopathy (septal thickness ≥15 mm) or infiltrative cardiomyopathy (eg. amyloid)]
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Current moderate to severe pulmonary hypertension (right ventricular systolic pressure of ≥40 mmHg)
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Oxygen dependent chronic lung disease
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Prolonged episodes of AF (>3 days or an AF burden >10%) within the preceding 3 months
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Presence of cardiac pacemaker or implantable cardioverter defibrillator
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Prior mechanical tricuspid valve replacement
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Pregnancy or lactation due to concerns about the effect of radiation from the pacemaker implantation procedure on the fetus
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Known allergic reactions to components of the pacemaker or leads
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Febrile illness within 3 days of trial enrollment
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Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
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Control Participant Exclusion Criteria: same
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 2 | Inova Health System | Falls Church | Virginia | United States | 22042 |
Sponsors and Collaborators
- Inova Health Care Services
- Medtronic
Investigators
- Principal Investigator: Brett Atwater, MD, Inova Health Care Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- U22-04-4739