Skip to content

Compared With 2 Different Ablation Strategies Clinical Outcome for Treating Patients With Paroxysmal Atrial Fibrillation

Compared With 2 Different Ablation Strategies Clinical Outcome for Treating Patients With Paroxysmal Atrial Fibrillation,Prospective Randomised Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03190395
Enrollment
120
Registered
2017-06-16
Start date
2019-01-20
Completion date
2021-08-31
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Paroxysmal Atrial Fibrillation, Circumferential Pulmonary Vein Isolation(CPVI), Leftatrium Roofline Ablation(LARA), Longterm success rate

Brief summary

Atrial fibrillation (AF) is the most serious atrial electrical activity disorders, is also one of the common tachyarrhythmias.Circumferential pulmonary Vein Isolation (CPVI) is considered to be the cornerstone of paroxysmal atrial fibrillation ablation, but recently reported in the literature that pure CPVI treatment for paroxysmal atrial fibrillation the 5-year success rate as low as 46.6%, and the incidence of atrial reentry tachycardia is also high in the follow-up period. Therefore it is necessary for us to explore whether the success rate of CPVI combined with Leftatrium Roofline Ablation (CPVI + LARA) for paroxysmal atrial fibrillation is higher than the pure CPVI.

Detailed description

Atrial fibrillation (AF) refers to the orderly loss of atrial electrical activity, replaced by rapid and disorderly atrial fibrillation wave, is the most acute atrial electrical activity disorders, is also one of the common tachyarrhythmias. So far, the mechanism of atrial fibrillation has not yet been completely clarified. At present, there are various mechanisms to participate in the occurrence and maintenance of atrial fibrillation, which mainly involves two aspects. One is the triggering factor of atrial fibrillation, and the other is the occurrence and maintenance of atrial fibrillation (substrate). Trigger factors are varied, including sympathetic and parasympathetic stimulation, bradycardia, atrial premature beats or tachycardia, atrioventricular bypass and acute atrial pull, etc, which pulmonary vein electrical activity triggered the most common, but also is an most important theoretical Basis for the Radiofrequency Catheter Ablation of Atrial Fibrillation . Substrate is a necessary condition for the onset and maintenance of atrial fibrillation. Electrical remodeling and structural remodeling are by shortening the atrial effective refractory period. Atrial dilatation and atrial fibrosis play a major role in the formation of atrial fibrillation reentry.Circumferential pulmonary Vein Isolation (CPVI) is considered to be the cornerstone of paroxysmal atrial fibrillation ablation, but recently reported in the literature that pure CPVI treatment for paroxysmal atrial fibrillation the 5-year success rate as low as 46.6%, and the incidence of atrial reentry tachycardia is also high in the follow-up period. Therefore it is necessary for us to explore whether the success rate of CPVI combined with Leftatrium Roofline Ablation (CPVI + LARA) for paroxysmal atrial fibrillation is higher than the pure CPVI.

Interventions

PROCEDURECPVI Group

CPVI Group:The ablation strategy of Circumferential pulmonary vein isolation (CPVI)will be operated on 60 patients with paroxysmal atrial fibrillation.

PROCEDURECPVI+LARA Group

CPVI+LARA Group: The ablation strategy of Circumferential pulmonary vein isolation combine with Left atrium roofline ablation(CPVI+LARA) will be operated on 60 patients with paroxysmal atrial fibrillation.

Sponsors

Nanfang Hospital, Southern Medical University
CollaboratorOTHER
Zhujiang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Contorol Group:Pure Circumferential pulmonary vein isolation(CPVI) Experimental Group:Circumferential pulmonary vein isolation combine with Left atrium roofline ablation(CPVI+LARA)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

\- (1)Patients between 18-80 year-old with paroxysmal atrial fibrillation have radio frequency ablation operation indication and are willing to require AF ablation therapy. (2)Voluntary consent of informed consent (3)No AF Ablation history before admission

Exclusion criteria

* (1) Permanent or persistent AF (2) The diameter of left atrium \>50mm (3) Previous AF/AFL/AT Radio Frequency Ablation (4) Congenital heart disease and/or Cardiac Surgical procedures (5) AF with rheumatic valvular disease (6) LV ejection fraction \<45% (7) Intracardiac thrombi

Design outcomes

Primary

MeasureTime frameDescription
Maintenance time of sinus rhythmThe two groups will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operationTo evaluate the effectiveness of the ablation operation, we will observe how long will these patients keep sinus rhythm after operation.

Secondary

MeasureTime frameDescription
The size of the left atriumPatients's size of the left atrium will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operationThe size of the left atrium measured by Transthoracic echocardiography
The Left Ventricular Ejection FractionPatients's LV ejection fraction will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operationThe Left Ventricular Ejection Fraction measured by Transthoracic echocardiography maybe improve when heart rhytum becom sinus rhytum after ablation operation.

Countries

China

Contacts

Primary ContactLiqing Wang, Doctor
wliqing2014@163.com+86-02062783391

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026