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

NCT ID: NCT01686542

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2020-06-30

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPVI+RSM group

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

Group Type: EXPERIMENTAL

CPVI plus renal sympathetic modification

Intervention Type: PROCEDURE

CPVI plus renal denervation to reduce atrial arrhythmia recurrence.

CPVI group

Circumferential pulmonary vein isolation is done alone for atrial fibrillation.

Group Type: ACTIVE_COMPARATOR

CPVI

Intervention Type: PROCEDURE

CPVI alone to reduce atrial arrhythmia recurrence.

Interventions

CPVI plus renal sympathetic modification

CPVI plus renal denervation to reduce atrial arrhythmia recurrence.

Intervention Type: PROCEDURE

CPVI

CPVI alone to reduce atrial arrhythmia recurrence.

Intervention Type: PROCEDURE

Other Intervention Names

Circumferential pulmonary vein isolation (CPVI); renal denervation; renal ablation; circumferential pulmonary vein ablation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yuehui Yin

Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

2ndChongqingMU

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuehui Yin, MD

Role: CONTACT

yinyh63@163.com

0086-13508335502

Facility Contacts

Yuehui Yin, MD

Role: primary

yinyh63@163.com

0086-23-63693766

Other Identifiers

SWAN-cpAF

Identifier Type: -

Identifier Source: org_study_id