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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CPVI plus renal sympathetic modification
CPVI
Sponsored by
The Second Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 2ndChongqingMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CPVI+RSM group

CPVI group

Arm Description

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

Circumferential pulmonary vein isolation is done alone for atrial fibrillation.

Outcomes

Primary Outcome Measures

The relapse rate of atrial tachyarrhythmia
Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed

Secondary Outcome Measures

Full Information

First Posted
September 13, 2012
Last Updated
March 18, 2019
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01686542
Brief Title
CPVI Plus Renal Sympathetic Modification Versus CPVI Alone for AF（Atrial Fibrillation） Ablation
Official Title
Circumferential Pulmonary Vein Isolation (CPVI) Plus Renal Sympathetic Modification Versus CPVI Alone for AF Ablation: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPVI+RSM group
Arm Type
Experimental
Arm Description
Circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification for atrial fibrillation ablation.
Arm Title
CPVI group
Arm Type
Active Comparator
Arm Description
Circumferential pulmonary vein isolation is done alone for atrial fibrillation.
Intervention Type
Procedure
Intervention Name(s)
CPVI plus renal sympathetic modification
Other Intervention Name(s)
Circumferential pulmonary vein isolation (CPVI), renal denervation, renal ablation
Intervention Description
CPVI plus renal denervation to reduce atrial arrhythmia recurrence.
Intervention Type
Procedure
Intervention Name(s)
CPVI
Other Intervention Name(s)
circumferential pulmonary vein ablation
Intervention Description
CPVI alone to reduce atrial arrhythmia recurrence.
Primary Outcome Measure Information:
Title
The relapse rate of atrial tachyarrhythmia
Description
Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed
Time Frame
Four years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuehui Yin, MD
Phone
0086-13508335502
Email
yinyh63@163.com
Facility Information:
Facility Name
2ndChongqingMU
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD
Phone
0086-23-63693766
Email
yinyh63@163.com
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD

12. IPD Sharing Statement

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

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