A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF II)
评估除导管消融之外的肾动脉去神经术以消除心房颤动的试验 (ERADICATE-AF II)
基本信息
- 批准号:10212737
- 负责人:
- 金额:$ 23.37万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-01 至 2024-07-31
- 项目状态:已结题
- 来源:
- 关键词:AblationAdverse effectsAmbulatory Blood Pressure MonitoringAmbulatory MonitoringAnti-Arrhythmia AgentsArrhythmiaAtrial FibrillationAutonomic ganglionAutonomic nervous systemBlood PressureCardiacCardiac ablationCardiovascular systemCessation of lifeClinicalClinical TrialsComplicationCoupledDenervationDevelopmentEFRACEmergency department visitEnrollmentEventFailureFrequenciesGoalsHospitalizationHourHypertensionLeadMeasurementMeasuresMediatingMedicalMuscleNerveNorepinephrineOutcomeOutputPatientsPharmaceutical PreparationsPosturePre-Clinical ModelProceduresPublishingPulmonary veinsQuality of lifeRandomizedRandomized Clinical TrialsRecurrenceResistanceResistant HypertensionSafetySingle-Blind StudySympathetic Nervous SystemTechniquesTestingTherapeuticThickTimecardiovascular emergencyfollow-upindexingpilot trialpredict clinical outcomepressureprogramsrandomized trialrenal arterysuccesssymptomatic improvement
项目摘要
ABSTRACT
Pulmonary vein isolation (PVI) is the cornerstone of ablation strategies for atrial fibrillation (AF) and has been
consistently effective in reducing arrhythmia recurrence. Nonetheless, PVI has a recognized and not insignificant
rate of short- and long-term failure, often requires multiple procedures and is less effective for persistent AF. The
mechanisms of AF are diverse, but increased efferent cardiac sympathetic nerve stimulation can contribute to the
development and perpetuation of AF. Reduction in cardiac sympathetic input has been proposed as a logical
adjunctive approach to PVI but its technical application via cardiac ablation has had only mixed or modest results.
The therapeutic objective of reduced cardiac sympathetic stimulation can be potentially accomplished by renal
artery denervation (RDN), a technique originally developed for the treatment of resistant hypertension. RDN’s
potential for antiarrhythmic effect may be mediated by reduced central nervous sympathetic output and is
exemplified by a decrease in whole-body norepinephrine spillover and muscle-sympathetic nerve activity.
The recently completed randomized, multicenter, single-blind clinical trial, ERADICATE-AF, was published in
JAMA and convincingly demonstrated that RDN plus PVI resulted in a relative 43% reduction (absolute change,
15%; P < 0.001) in recurrent incident AF during one year of follow-up. The trial enrolled > 300 patients with
paroxysmal AF referred for ablation, all with poorly controlled hypertension despite medication. There was no
difference in complications between the 2 groups. The trial results suggested that a strategy of reducing cardiac
autonomic input is an effective antiarrhythmic approach. Until now, this approach has only been tested in patients
with resistant and/or poorly controlled hypertension.
We propose a multicenter, single-blinded, randomized clinical trial to Evaluate Renal Artery Denervation In
Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF II), to test the hypothesis that RDN
in addition to PVI enhances long-term antiarrhythmic efficacy in comparison to PVI alone for patients with
persistent AF with controlled hypertension or without hypertension. The trial will be advantaged by performing
implantable loop recordings (ILR) in all patients, which will facilitate the calculation of AF burden, now recognized
as a powerful predictor of clinical outcome. With successful completion of this pilot program, we hope to launch
a large-scale trial with cardiovascular and death events as endpoints.
The principal goal of this trial is to determine if adjunctive RDN results in reduced AF burden over time in
comparison to patients who undergo only PVI. The secondary goals are to examine: procedural complication,
postural blood pressure, and pressure control as assessed by 24-hour ambulatory monitors; autonomic nervous
system effects; frequency of cardiovascular hospitalizations; return to persistent AF; need for repeat ablation
procedures; and quality of life.
摘要
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Jonathan S. Steinberg其他文献
Continuous monitoring of atrial fibrillation in heart failure.
持续监测心力衰竭中的房颤。
- DOI:
10.1016/j.hfc.2013.06.002 - 发表时间:
2013 - 期刊:
- 影响因子:3.4
- 作者:
B. Herweg;S. Barold;Jonathan S. Steinberg - 通讯作者:
Jonathan S. Steinberg
PO-01-167 strongEFFICACY OF BOTULINUM TOXIN TYPE A (AGN-151607) FOR THE PREVENTION OF POSTOPERATIVE ATRIAL FIBRILLATION IN CARDIAC SURGERY PATIENTS: ATRIAL FIBRILLATION AND ANTICOAGULATION RESULTS FROM THE PHASE 2 NOVA STUDY/strong
PO-01-167 肉毒杆菌毒素 A 型(AGN-151607)预防心脏手术患者术后心房颤动的强效疗效:来自 2 期 NOVA 研究的心房颤动和抗凝结果/强
- DOI:
10.1016/j.hrthm.2023.03.558 - 发表时间:
2023-05-01 - 期刊:
- 影响因子:5.700
- 作者:
Nathan Waldron;Alexandra OSullivan;Jonathan P. Piccini;Matthew Romano;Pierre Voisine;Wilson Titanji;Richard Leaback;William Ferguson;Jonathan S. Steinberg - 通讯作者:
Jonathan S. Steinberg
Role of Atrioventricular Junctional Ablation and Cardiac Resynchronization Therapy in Patients with Chronic Atrial Fibrillation
- DOI:
10.1016/j.ccep.2018.11.013 - 发表时间:
2019-03-01 - 期刊:
- 影响因子:
- 作者:
Jonathan S. Steinberg - 通讯作者:
Jonathan S. Steinberg
The Influence of Bundle Branch Morphology on Outcomes with Cardiac Resynchronization in NYHA Class III/IV Heart Failure: Insights from the COMPANION Study
- DOI:
10.1016/j.cardfail.2010.06.221 - 发表时间:
2010-08-01 - 期刊:
- 影响因子:
- 作者:
Leslie A. Saxon;Jonathan S. Steinberg;Patrick Yong;Elizabeth Galle;John Boehmer - 通讯作者:
John Boehmer
Safety and efficacy of flestolol, a new ultrashort-acting beta-adrenergic blocking agent, for supraventricular tachyarrhythmias
- DOI:
10.1016/s0002-9149(86)80028-5 - 发表时间:
1986-11-01 - 期刊:
- 影响因子:
- 作者:
Jonathan S. Steinberg;Richard J. Katz;John C. Somberg;Deborah Keefe;Atul R. Laddu;Judy Burge - 通讯作者:
Judy Burge
Jonathan S. Steinberg的其他文献
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{{ truncateString('Jonathan S. Steinberg', 18)}}的其他基金
A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF II)
评估除导管消融之外的肾动脉去神经术以消除心房颤动的试验 (ERADICATE-AF II)
- 批准号:
10470105 - 财政年份:2021
- 资助金额:
$ 23.37万 - 项目类别:
A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF II)
评估除导管消融之外的肾动脉去神经术以消除心房颤动的试验 (ERADICATE-AF II)
- 批准号:
10685356 - 财政年份:2021
- 资助金额:
$ 23.37万 - 项目类别:
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