Atrial FibrillationNCT01686542
CPVI Plus Renal Sympathetic Modification Versus CPVI Alone for AF（Atrial Fibrillation） Ablation
A study testing CPVI plus renal sympathetic modification and CPVI in people with Atrial Fibrillation, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CPVI plus renal sympathetic modification and CPVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • ≥ 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
Who cannot join
- • 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2ndChongqingMU
Chongqing, Chongqing Municipality, 400010
Yuehui Yin, MD, 0086-23-63693766, yinyh63@163.com
Yuehui Yin, MD
About this study
Official title: 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.
Read the 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
- Being tested
- CPVI plus renal sympathetic modification, CPVI
- Keywords
- atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPVI plus renal sympathetic modificationProcedure or surgery
Also called Circumferential pulmonary vein isolation (CPVI), renal denervation, renal ablation
CPVI plus renal denervation to reduce atrial arrhythmia recurrence.
CPVIProcedure or surgery
Also called circumferential pulmonary vein ablation
CPVI alone to reduce atrial arrhythmia recurrence.
| Study group | Role | What they receive |
|---|---|---|
| CPVI+RSM group | Experimental | Circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification for atrial fibrillation ablation. Receives: Procedure: CPVI plus renal sympathetic modification |
| CPVI group | Active comparator | Circumferential pulmonary vein isolation is done alone for atrial fibrillation. Receives: Procedure: CPVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relapse rate of atrial tachyarrhythmia
Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686542
- Sponsor's protocol ID
- SWAN-cpAF
- Status last verified
- Mar 2019
- First submitted
- 13 Sep 2012
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumferential Pulmonary Vein Isolation (CPVI) Plus Renal Sympathetic Modification Versus CPVI Alone for AF Ablation: a Pilot Study
- ClinicalTrials.gov ID
- NCT01686542
- Acronym / sponsor ID
- SWAN-cpAF
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPVI+RSM group | Experimental | Procedure: CPVI plus renal sympathetic modificationCircumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification for atrial fibrillation ablation. |
| CPVI group | Active comparator | Procedure: CPVICircumferential pulmonary vein isolation is done alone for atrial fibrillation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • ≥ 18 years old, and ≤ 75 years old of age
Key exclusion criteria (11 listed)
- • transesophageal echocardiography found thrombus in left atrial appendage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPVI plus renal sympathetic modificationAlso: Circumferential pulmonary vein isolation (CPVI), renal denervation, renal ablationCPVI plus renal denervation to reduce atrial arrhythmia recurrence. | Procedure or surgery | CPVI+RSM group |
| CPVIAlso: circumferential pulmonary vein ablationCPVI alone to reduce atrial arrhythmia recurrence. | Procedure or surgery | CPVI group |
Primary outcome
The relapse rate of atrial tachyarrhythmia
Time frame: Four years
Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPVI plus renal sympathetic modification and CPVI in people with Atrial Fibrillation, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuehui Yin, MD (0086-13508335502, yinyh63@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relapse rate of atrial tachyarrhythmia (time frame: Four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.