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

NCT01686542 | Unknown DMC

• 1 other identifier: SWAN-cpAF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• The relapse rate of atrial tachyarrhythmia

  Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed

  Four years

Study Arms (2)

CPVI+RSM group

EXPERIMENTAL

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

Procedure: CPVI plus renal sympathetic modification

CPVI group

ACTIVE COMPARATOR

Circumferential pulmonary vein isolation is done alone for atrial fibrillation.

Procedure: CPVI

Interventions

CPVI plus renal sympathetic modification PROCEDURE

CPVI plus renal denervation to reduce atrial arrhythmia recurrence.

Also known as: Circumferential pulmonary vein isolation (CPVI), renal denervation, renal ablation

CPVI+RSM group

CPVI PROCEDURE

CPVI alone to reduce atrial arrhythmia recurrence.

Also known as: circumferential pulmonary vein ablation

CPVI group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

2ndChongqingMU

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yuehui Yin, MD

CONTACT

0086-13508335502; yinyh63@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 18, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

CN (1)