REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT), a Phase I Prospective Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Left Ventricular Ejection Fraction
- 发起方
- Inova Health Care Services
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in myocardial performance index (MPI) as compared to Baseline
- 状态
- 进行中（未招募）
- 最后更新
- 4个月前
概览
简要总结
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.
详细描述
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).
研究者
入排标准
入选标准
- •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
- •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.
排除标准
- •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)
- •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
结局指标
主要结局
Change in myocardial performance index (MPI) as compared to Baseline
时间窗: 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.