Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Exercise tolerance as measured by the Six-Minute Walk Test
研究概览
简要总结
This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.
详细描述
Cardiac resynchronization therapy (CRT) after atrioventricular node (AVN) ablation for permanent atrial fibrillation (AF) has led to better outcomes in heart failure (HF) patients with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) compared to pharmacotherapy. Emerging evidence has demonstrated patients with HFpEF may benefit from a higher heart rate compared to standard heart-lowering therapies. The optimal pacing rate for CRT after AVN ablation in persistent AF and HFpEF remains unknown.
This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test.
The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa. Patient mortality and HF hospitalizations will be recorded at each phase. An electrocardiogram, echocardiogram, pacemaker interrogation, BNP and creatinine levels, KCCQ-12, six-minute walk test, and physical activity measure will be obtained at baseline, 3 months, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •History of persistent or permanent atrial fibrillation
- •Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
- •History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
- •N-terminal pro-B-type natriuretic peptide (NT-proBNP) >400 pg/mL in the last 24 months
- •Clinical HF diagnosis or NYHA class II or higher
- •Able to provide informed consent
排除标准
- •Wide QRS (greater than 150ms)
- •Isolated RV pacing
- •Severe valvular disease
- •Severe coronary artery disease as defined by one of the following:
- •ACS or PCI within 1 year
- •Any angina (CCS class 1+)
- •Unrevascularizable severe CAD (>70% stenosis in 1+ major vessels and/or based on functional assessment)
- •Significant primary pulmonary disease on home oxygen
- •Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test
- •Ventricular ectopy >15% premature ventricular contractions (PVC)
- •End stage cancer diagnosis
- •Life expectancy less than one year
- •Palliative or hospice care
- •Hypertrophic cardiomyopathy (HCM)
- •Uncorrected ventricular septal defect
- •Infiltrative cardiomyopathy (CM)
- •Uncontrolled hypertension as defined by blood pressure >160/100 mm Hg on two measurements ≥15 minutes apart
- •Hemoglobin <7 g/dL
- •Age >90 years old
- •Pregnant or intends to become pregnant
结局指标
主要结局
Exercise tolerance as measured by the Six-Minute Walk Test
时间窗: 3 months
Exercise tolerance as measured by the Six-Minute Walk Test
次要结局
- Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire(3 months)
- Function as measured by the International Physical Activity Questionnaire(3 months)
- Change in B-type natriuretic peptide (BNP)(3 months)
- Change in creatinine(3 months)
- Change in New York Heart Association Class(3 months)
- Atrial fibrillation burden(3 months)
- Hospitalization for heart failure(3 months)
- Death due to heart failure(3 months)
- Death due to myocardial infarction(3 months)
- Death due to stroke(3 months)
- Hospitalization for atrial fibrillation(3 months)
- Administration of loop diuretic/anti-arrhythmic drug(3 months)