CPVI Plus Renal Sympathetic Modification Versus CPVI Alone for AF（Atrial Fibrillation） Ablation

Chongqing Medical University

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: CPVI plus renal sympathetic modification; Procedure: CPVI

Study type: Interventional

Funder types: Other

Identifiers

NCT01686542

SWAN-cpAF

Details and patient eligibility

About

The study is designed as a randomized control trial. The purpose of this study is to observe the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification (RSM) with CPVI alone.

Full description

Basic studies suggested that sympathetic nerves over-activity played an important role in the pathophysiological changes of arrhythmia occurrence. Present studies of renal ablation show a new method to decrease sympathetic nerves activity. Circumferential pulmonary vein isolation (CPVI) is an accepted ablation method for atrial fibrillation. The investigators plan to evaluate the efficiency and safety of CPVI plus renal sympathetic modification for atrial fibrillation ablation comparing with CPVI alone. The trial is going to recruit 100 patients randomized into two groups (CPVI+RSM group VS CPVI group = 50:50) with a follow-up duration of 4 years. The investigators aim to observe the relapse of atrial tachyarrhythmia lasting more than 30 seconds, the incidence of composite cardiovascular events after renal sympathetic modification, and safety and efficacy of the intervention, comparing with CPVI alone.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • ≥ 18 years old, and ≤ 75 years old of age

  • more than half a year history of atrial fibrillation, no matter paroxysmal or persistent, with clinical symptom or ECG proved
  • be ineffective to at least one kind of anti-arrhythmic drugs treatment
  • echocardiography has done to except structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy
  • estimated glomerular filtration rate (eGFR) of ≥ 45ml/min
  • is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion criteria

• • transesophageal echocardiography found thrombus in left atrial appendage

  • past history of atrial fibrillation surgical maze procedure
  • estimated glomerular filtration rate (eGFR) of < 45mL/min
  • has the history of renal restenosis or renal stents implantation
  • has experienced AMI（acute myocardial infarction） (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
  • patients with sick sinus syndrome
  • pregnant women
  • mental disorders
  • patients that have allergy to contrast agent
  • patients that do not go with follow-up
  • others such as researcher considers it is not appropriate to be included into the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CPVI+RSM group

Experimental group

Description:

Circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification for atrial fibrillation ablation.

Treatment:

Procedure: CPVI plus renal sympathetic modification

CPVI group

Active Comparator group

Description:

Circumferential pulmonary vein isolation is done alone for atrial fibrillation.

Treatment:

Procedure: CPVI