AVAIL CLS/CRT: AV-node Ablation With CLS and CRT Pacing Therapies for the Treatment of AF
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 153
- 试验地点
- 10
- 主要终点
- Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent pacing therapy.
详细描述
This study is a multi-center, prospective, randomized, blinded trial. The study will consist of approximately 265 patients who require treatment of persistent or permanent, symptomatic atrial fibrillation by atrioventricular (AV) node ablation and permanent pacing therapy i.e. "Ablate and Pace" therapy. All patients enrolled into the clinical study will be randomly assigned to one of three groups using a randomization ratio of 2:2:1. Patients will be assigned to receive either biventricular (biV) pacing with CLS-based rate adaptive pacing using the legally marketed Protos DR/CLS (Group 1), or biventricular pacing with accelerometer-based rate adaptive pacing using the Stratos LV (Group 2), or right ventricular (RV) pacing with accelerometer-based rate adaptive pacing using the Stratos LV (Group 3). Patients in all three groups will be implanted with legally marketed right and left ventricular pacing leads. The patients, the core lab used to interpret the echocardiographic data and the Clinical Events Committee adjudicating crossover, patient death and congestive heart failure (CHF) hospitalizations will be blinded to the randomization assignment.
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
- Single (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
- •Meet the indications for therapy
- •Persistent, symptomatic AF with poorly controlled rapid ventricular rates or permanent, symptomatic AF with poorly controlled rapid ventricular rates.
- •Eligible for AV nodal ablation and permanent pacemaker implantation
- •NYHA Class II or III heart failure
- •Age ≥ 18 years
- •Understand the nature of the procedure
- •Ability to tolerate the surgical procedure required for implantation
- •Give informed consent
- •Able to complete all testing required by the clinical protocol
- •Available for follow-up visits on a regular basis at the investigational site
排除标准
- •Meet one or more of the contraindications
- •Have a life expectancy of less than six months
- •Expected to receive heart transplantation within six months
- •Enrolled in another cardiovascular or pharmacological clinical investigation
- •Patients with an ICD, or being considered for an ICD
- •Patients with previously implanted biventricular pacing systems
- •Patients with previously implanted single or dual chamber pacing system with > 50% documented ventricular pacing
- •Patients with previous AV node ablation
- •Six-minute walk test distance greater than 450 meters
- •Any condition preventing the patient from being able to perform required testing
- •Presence of another life-threatening, underlying illness separate from their cardiac disorder
- •Conditions that prohibit placement of any of the lead systems
研究组 & 干预措施
1
Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)
干预措施: Protos DR/CLS and Stratos LV CRT pacemakers (Device)
2
Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)
干预措施: Protos DR/CLS and Stratos LV CRT pacemakers (Device)
3
Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)
干预措施: Protos DR/CLS and Stratos LV CRT pacemakers (Device)
结局指标
主要结局
Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months
时间窗: Change from baseline to six months post-procedure
Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))
Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure
时间窗: At six months post-procedure
Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications.
次要结局
- Change in Quality Of Life (QOL) Score Over 6 Months Calculated as QOL Score at Baseline - QOL Score at 6 Months(Change from baseline to six months post-procedure)
- Mortality Rate(At six months post-procedure)
- Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Diastolic Volume(Change from baseline to six months post-procedure)
- Changes in New York Heart Association (NYHA) Classification(Change from baseline to six months post-procedure)
- Change in Six-minute Walk Test(Change from baseline to 6 months post-procedure)
- Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction(Change from baseline to six months post-procedure)
- Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations(At six months post-procedure)
- Cardiac Remodeling Assessments by Echocardiography - Change in Left Atrial Volume(Change from baseline to six months post-procedure)
- Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Mass(Change from baseline to six months post-procedure)
- Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular End Systolic Volume(Change from baseline to six months post-procedure)