Randomized Clinical Trial of Radiofrequency Ablation for Atrial Fibrillation in Patients With Heart Failure With Preserved Ejection Fraction for Reduced Healthcare Utilization
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Rate of healthcare utilization.
研究概览
简要总结
The purpose of this study is to determine if patients who receive an early radiofrequency ablation will have fewer hospitalizations, unplanned office visits, and emergency room visits than those patients treated with medical therapy alone.
详细描述
In this study, subjects with HFpEF and new onset paroxysmal or persistent AF (diagnosed in the past 6 months) will be randomized in a 1:1 ratio to either intervention or medical therapy alone. Twenty subjects will be enrolled to each group for a total of 40 subjects across all enrolling sites. Subjects randomized to the intervention Group will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter. The medical therapy alone cohort will receive management of AF consisting of either rate or rhythm control. All patients will be implanted with an implantable cardiac monitor (ICM) as standard of care for AF management in heart failure except for those who already have in place an existing cardiac implantable electronic device (CIED) such as pacemaker, ICM, or implantable cardiac defibrillator (ICD). The ICM procedure will occur within 2 calendar months of randomization for both study groups (intervention or control). For the intervention arm, the CIED procedure will occur prior to or at the time of the AF ablation procedure. Subjects will be followed for 1 year with in-clinic visits occurring at 3, 6, and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years at date of consent.
- •LVEF >50% as determined on imaging study measured in the last 6 calendar months prior to or on consent date.
- •Hospitalized for HF within the past 12 calendar months prior to consent date.
- •Stabilized patients defined as being off all IV therapies for at least 24 hours prior to consent date.
- •Paroxysmal AF diagnosed within the past 6 calendar months or early persistent AF, defined as an AF episode lasting greater than 7 days but less than 6 calendar months prior to consent date.
- •Indicated for oral anticoagulation according to current guidelines (CHA2DS2-VASc ≥ 2 in men or ≥ 3 in women at the time of consent)*
- •Patient with CIED in situ at time of consent or scheduled to undergo ICM implant for AF management within 2 calendar months of randomization.
排除标准
- •Previous catheter or surgical ablation of AF any time in the past.
- •Long-standing persistent AF (>1-year prior to consent date) or permanent AF.
- •Chronic pulmonary disease requiring home oxygen or oral/IV steroid therapy in the past 12 calendar months prior to consent date.
- •Active infection at time of consent but may be re-considered for enrollment later after effective treatment.
- •Left atrial size >50 mm as measured by echo in the past 6 calendar months prior to consent date.
- •Untreated obstructive sleep apnea any time in past.
- •Myocardial infarction in past 3 calendar months prior to consent date.
- •Coronary artery bypass graft (CABG) surgery in past 3 calendar months prior to consent date.
- •Stroke in past 3 calendar months prior to consent date.
- •Intra-cardiac thrombus precluding ability to undergo AF ablation at time of consent but may be re-considered for enrollment later after effective treatment.
- •Infiltrative cardiomyopathy (sarcoid, amyloid) any time in past.
- •Active myocarditis at time of consent but may be re-considered for enrollment later after effective treatment.
- •Hypertrophic cardiomyopathy at any time in past.
- •Known pericardial constriction.
- •Uncontrolled hypertension (SBP > 160 mmHg) at time of consent but may be re- considered for enrollment later after effective treatment.
- •Untreated hypothyroidism or hyperthyroidism but may be re-considered for enrollment later after effective treatment.
- •Pregnancy or nursing.
- •Valvular AF or presence of a prosthetic valve.
- •Undergoing dialysis or have advanced renal dysfunction (eGFR <30 ml/min/m2) defined as 3 times the upper limits of AST or ALT during the past 6 calendar months.
- •Contraindication to anticoagulation.
- •Metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting study (EP) study and ablation.
- •Cognitive impairment.
- •Life expectancy < 1 year following consent date.
- •Unwilling to comply with all study protocol-required testing.
- •Unwilling or unable to give informed consent.
研究组 & 干预措施
Conventional Treatment
Subjects will receive management of AF consisting of either rate or rhythm control.
AF Ablation
Subjects will undergo early RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter
干预措施: RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter (Procedure)
结局指标
主要结局
Rate of healthcare utilization.
时间窗: up to 12 months
Number of unplanned office visits, hospitalizations, and emergency room visits.
次要结局
- Burden of Atrial Fibrillation (AF)(Between baseline and 12 months)
- Change in quality of life measures in Patient-Reported Outcomes Measurement Information System (PROMIS).(Between baseline and 6 months)
- 6-minute Walk Test(6 Months)
- Quality of life measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ)(Between baseline and 6 months)
研究者
Mehmet Aktas
Professor
University of Rochester