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

This study is currently recruiting participants.
Verified May 2013 by The Second Affiliated Hospital of Chongqing Medical University
Sponsor:
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01686542
First received: September 13, 2012
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: CPVI plus renal sympathetic modification
Procedure: CPVI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Circumferential Pulmonary Vein Isolation (CPVI) Plus Renal Sympathetic Modification Versus CPVI Alone for AF Ablation: a Pilot Study

Resource links provided by NLM:


Further study details as provided by The Second Affiliated Hospital of Chongqing Medical University:

Primary Outcome Measures:
  • The relapse rate of atrial tachyarrhythmia [ Time Frame: Four years ] [ Designated as safety issue: Yes ]
    Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Circumferential pulmonary vein isolation (CPVI)
  • renal denervation
  • renal ablation
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:
  • CPVI
  • circumferential pulmonary vein ablation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686542

Contacts
Contact: Yuehui Yin, MD 0086-13508335502 yinyh63@163.com

Locations
China, Chongqing
2ndChongqingMU Recruiting
Chongqing, Chongqing, China, 400010
Contact: Yuehui Yin, MD    0086-23-63693766    yinyh63@163.com   
Principal Investigator: Yuehui Yin, MD         
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
  More Information

No publications provided

Responsible Party: Yuehui Yin, Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT01686542     History of Changes
Other Study ID Numbers: SWAN-cpAF
Study First Received: September 13, 2012
Last Updated: May 2, 2013
Health Authority: China: Ethics Committee

Keywords provided by The Second Affiliated Hospital of Chongqing Medical University:
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014