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

Circumferential Pulmonary Vein Isolation (CPVI) Plus Renal Sympathetic Modification Versus CPVI Alone for AF Ablation: a Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: CPVI plus renal sympathetic modification; Procedure: CPVI

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • 2ndChongqingMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPVI+RSM group; Circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification for atrial fibrillation ablation.	Procedure: CPVI plus renal sympathetic modification; CPVI plus renal denervation to reduce atrial arrhythmia recurrence.; Other Names: renal denervation; renal ablation; Circumferential pulmonary vein isolation (CPVI)
Active Comparator: CPVI group; Circumferential pulmonary vein isolation is done alone for atrial fibrillation.	Procedure: CPVI; CPVI alone to reduce atrial arrhythmia recurrence.; Other Names: circumferential pulmonary vein ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relapse rate of atrial tachyarrhythmia	Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed	Four years

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: September 13, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 18, 2012

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SWAN-cpAF