Atrial Fibrillation, CryoAblation, Pulmonary Vein Isolation
Conditions
Keywords
Atrial Fibrillation, CryoAblation, pulmonary vein isolation, wide area circumferential ablation, contact force
Brief summary
The purpose of this randomized clinical trial is to compare the efficacy and safety of wide area circumferential ablation using contact force catheter with cryoballoon ablation for the treatment of paroxysmal atrial fibrillation.
Detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with stroke, reductions in quality of life and overall survival. Previous studies have shown that cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation. However, the pulmonary vein isolation for radiofrequency catheter ablation in previous studies was done around each pulmonary-vein antrum, and it's not wide area circumferential ablation. Moreover, the induction of atrial fibrillation by isoproterenol or programmed stimulation and burst pacing was not performed in most of previous studies. We hypothesize that wide area circumferential ablation with contact force catheter and combined catheter ablation the potential atrial triggers and/or other atrial arrhythmias induced by aggressive induction is more effective than cryoballoon ablation in patients with paroxysmal atrial fibrillation.
Interventions
PROCEDUREWide area circumferential ablation
Wide area circumferential ablation with contact force catheter will be performed in Patients allocated in this group,the induction of atrial fibrillation by isoproterenol or programmed stimulation and burst pacing will be performed. If frequent atrial premature beats are found beyond pulmonary vein, activation mapping will be performed for eliminating the triggers. If atrial tachycardias(ATs)are induced, activation mapping the ATs and ablation will be performed. Electrical isolation of pulmonary veins and elimination the triggers and ATs induced by isoproterenol or programmed stimulation and burst pacing are the endpoints of ablation
PROCEDURECryoballoon ablation
In the cryoballoon procedures, pulmonary vein isolation (PVI) was achieved using fluoroscopic guidance to position the cryoballoon catheter. Once PV-to-balloon occlusion was confirmed by retrograde radiopaque contrast agent retention, circumferential ablation was performed by freezing with a single-shot delivery of coolant to the balloon.
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
two groups, group one is for Wide Area Circumferential Ablation With Contact Force catheter, group two is for Cryoballoon Ablation
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Symptomatic PAF with at least two episodes and at least one episode documented (30 seconds episode length, documented by ECG within last 12 months). Documented treatment failure for effectiveness of at least one anti-arrhythmic drug(AAD Type I or III, including β-blocker and AAD intolerance). 2. ≥ 18 and ≤ 75 years of age. 3. Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol. 4. Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard RF ablation technique. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document. All the details have been presented to him and he has signed the informed consent form for the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first documented recurrence of atrial arrhythmias | 12 months | a blanking period of three months will be maintained after the initial procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| all-cause death | 12 months | all-cause death |
| Arrhythmia-related death | 12 months | Arrhythmia-related death |
| total procedural duration | 12 months | time of total procedural |
| total time of fluoroscopy | 12 months | total time of fluoroscopy |
| time to the first occurrence of each of the components of the primary outcome | 12 months | a blanking period of three months will be maintained after the initial procedure |
| time to first cardiovascular hospitalization | 12 months | a blanking period of three months will be maintained after the initial procedure |
| number of cardiovascular hospitalizations (over-night stays) | 12 months | a blanking period of three months will be maintained after the initial procedure |
| quality of life changes at 12 months compared to baseline | 12 months | with the evaluation of the MOS item short from health survey（SF-36） |
| time to first symptomatic AF recurrence | 12 months | a blanking period of three months will be maintained after the initial procedure |
| time to recurrent atrial fibrillation (AF) | 12 months | a blanking period of three months will be maintained after the initial procedure |
Countries
China
Contacts
Primary ContactZHIYU LING, MD
Backup ContactYANPING XU, MD
Outcome results
None listed