Atrial Fibrillation (AF)
Conditions
Keywords
Pulmonary vein isolation, Transition Zone Modification, Atrial Fibrillation
Brief summary
This study investigates two treatments for atrial fibrillation (AF) patients without low-voltage-areas (LVAs). It aims to determine whether adding transition zone modification (TZM) to the pulmonary vein isolation (PVI) improves long-term outcomes compared to PVI alone.
Interventions
PROCEDUREPulmonary vein isolation plus transition zone modification
For those who are randomized to PVI+TZM arm, additional TZM should be performed after finishing PVI ablation. PVI could be performed using open-irrigated contact-force catheter.
PROCEDUREPulmonary vein isolation alone
In periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl. PVI should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Follow-up physicians are blinded to treatment allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Aged 18 to 80 years AF referring for ablation No prior history of AF Absence of low-voltage areas during substrate mapping Presence of transition zone during substrate mapping Sign informed consent
Exclusion criteria
Presence of left atrial thrombus Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease Untreated hypothyroidism or hyperthyroidism Dialysis-dependent terminal renal failure Life expectancy \<12 months due to non-cardiovascular causes. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study Female under pregnancy or breast-feeding Involved in other studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From AF and/or ATs With or Without Antiarrhythmic Drugs (AADs) | at least 12 months follow up | Freedom from AF and/or ATs with or without antiarrhythmic drugs (AADs) at 12months after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking period) was censored. Each episode lasts \> 30 seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Peri-procedural Complications | 1 week after patient enrollment | Incidence of Peri-procedural Complications：stroke, cardiac perforation, PV stenosis, esophageal injury and death |
| Total procedure time | 1 week after patient enrollment | time that the patient spend in the procedure room |
| Total fluoroscopic time | 1 week after patient enrollment | the total fluoroscopy time, during PVI alone or PVI plus low-voltage substrate modification |
| Total RF delivery time | 1 week after patient enrollment | The cumulative duration (in minutes) of active radiofrequency (RF) energy application to the atrial tissue during the ablation procedure. |
Contacts
Primary ContactYue Qiu, M.D.
Backup ContactHongwu Chen, M.D.
Outcome results
None listed