Cardiac Resynchronization Therapy (CRT) Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT). A Prospective, Randomized, Postmarket, Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 64
- 主要终点
- Number of Patients With Improved Clinical Composite Score
研究概览
简要总结
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.
详细描述
This is a prospective, pilot, multi-center, double-blinded, randomized post-market study to assess the effect of left ventricular lead pacing location (guided via QLV measurement vs. standard of care approach) in non-LBBB patients.
In the QLV arm the physician will:
- Assess two branches of the coronary sinus - a non-traditional vessel (inclusive of the anterior region) will be tested first and a traditional free lateral branch will be tested second for LV lead placement.
- Measure QLV for each of the four cathodes of the left ventricular lead in each branch.
- Choose the vein branch and cathode with the longest QLV measurement and program a vector based on that cathode.
In the standard of care group, the left ventricular lead placement will be carried out according to the physician's standard of care implant approach.
The impact of the left ventricular lead position will be evaluated based on the patient's response to CRT utilizing the Clinical Composite Score (cardiovascular death, heart failure hospitalizations, New York Heart Association (NYHA) class, and Patient Global Assessment). Authorized site personnel conducting the NYHA class assessment and Patient Global Assessment will be blinded to the randomization assignment and lead implant technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have non-LBBB morphology (includes complete right bundle branch block and intraventricular conduction delay with a QRS duration ≥ 120ms)
- •Have the following indication per the 2013 updated American College of Cardiology Foundation/American Heart Association/Heart Rhythm Society guidelines:
- •Left ventricular ejection fraction (LVEF) ≤ 35%, sinus rhythm, ischemic or non-ischemic cardiomyopathy, a non-LBBB pattern with QRS duration ≥ 120 ms, and NYHA) class III/ambulatory class IV on guideline directed medical therapy
- •Receiving a new CRT implant or undergoing an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant with no more than 10% right ventricular pacing
- •Are 18 years or older, or of legal age to give informed consent specific to state and local law
- •Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations
排除标准
- •Irreversible occlusion of venous access that will prevent placement of the CRT system either through the right or left upper extremity venous system
- •Undergoing left ventricular lead placement via a surgical or epicardial approach
- •Cardiomyopathy due solely to valvular disease that is not repaired/replaced
- •Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by St. Jude Medical, during the course of this clinical study
- •LBBB: QRS width ≥ 120 ms, with predominantly negative QRS in lead V1, and upright, monophasic QRS in leads I and V6
- •Incomplete right bundle branch block - intraventricular conduction delay with a QRS duration between 110 and 119ms
- •Persistent or permanent atrial fibrillation
- •Pacemaker dependent
- •Patients who are being upgraded primarily due to right ventricular pacing
- •Women who are pregnant or who plan to become pregnant during the clinical trial
- •Life expectancy < 1 year
研究组 & 干预措施
QLV based implant strategy
QLV represents the pacing site with the largest amount of dyssynchrony as measured by the left ventricular electrical delay. The QLV based implant strategy finds the left ventricle vein branch and left ventricular lead cathode with the longest QLV measurement and places the lead at this location and programs the device using this lead cathode.
干预措施: QLV based implant strategy (Device)
Standard of care implant strategy
The placement of LV lead will be carried out according to the physician's standard of care implant approach.
干预措施: Standard of care implant strategy (Device)
结局指标
主要结局
Number of Patients With Improved Clinical Composite Score
时间窗: 12 months
Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score.
次要结局
未报告次要终点