Title of Trial
Catheter Ablation for Paroxysmal Atrial fibrillation Segmental Pulmonary Vein Ablation Versus Left Atrial Ablation
Date and Citation of Primary Publication(s) or References
November 11, 2003. Circulation
Purpose of the Trial
This trial directly compares segmental ostial ablation to electrically isolate the pulmonary veins with left atrial ablation to encircle the pulmonary veins.
Study Categories
Ablation and Atrial Fibrillation
Patient Population
Patients with symptomatic paroxysmal atrial fibrillation undergoing catheter ablation.
Inclusion Criteria
Patients with symptomatic paroxysmal atrial fibrillation undergoing catheter ablation.
Exclusion Criteria
- Congestive heart failure
- A left ventricular ejection fraction < 35%
- A left atrial diameter > 55mm
- A previous ablation
Study Design
Patients were randomized to undergo PV isolation by either segmental ostial PV ablation (n=40) or left atrial ablation (n=40). Segmental PV ablation was performed by using a temperature controlled, deflectable, 4mm tip catheter positioned at the ostial site with the earliest bipolar PV potentials. Lesions were delivered for 20 to 45 seconds at a target temperature of 52 degrees Celsius and maximum output of 35 Watts. For left atrial ablation, a 3-D electroanatomic map was constructed. An 8mm tip, deflectable catheter was used to ablate 1-2 cm from the PV ostea using a target temperature of 55 degrees Celsius and a maximum power of 60 Watts. Ablation lesions were applied for at least 20 seconds and until the maximum local electrogram decreased by >50% or to <0.1mV. Additional ablation lines connected the left and right sided PVs as well as a line connecting from the left sided encircling lesion and the lateral mitral valve annulus.
Primary Endpoint
Freedom from recurrent paroxysmal atrial fibrillation off antiarrhythmic drug therapy after a single ablation procedure.
Secondary Endpoints
N/A
Baseline Characteristics
| | Segmental Ostial Ablation
(n=40) | Left Atrial Ablation
(n=40) |
| Age (years) | 51 ± 10 | 54 ± 11 |
| Gender (%Male) | 77.5% | 77.5% |
| Duration of AF (years) | 7 ± 6 | 7 ± 6 |
| LVEF | 0.55 ± 0.04 | 0.57 ± 0.05 |
| Left atrial diameter (mm) | 39 ± 5 | 41 ± 6 |
| Stuctural heart disease | 3 | 1 |
Follow-up: Mean follow-up 164 ± 100 days
Results
After the first ablation procedure, recurrence of PAF was seen in 13 (42%) of the 40 patients who had segmental ostial ablation as compared with only 4 (10%) of the 40 patients who underwent left atrial ablation. At six months follow-up, 67% of patients who underwent segmental ostial ablation were free from symptomatic PAF as compared with 88% of patients who had left atrial ablation.
Repeat ablation procedure was performed in 7 of 40 patients in the segmental otial ablation group and none of the patients who had left atrial ablation. Six of the seven patients who had a repeat ablation had a left atrial ablation. In six months follow-up after most recent ablation, there was freedom from symptomatic PAF recurrence in 67% of patients who underwent only segmental ostial ablation as compared with 89% freedom from symptomatic PAF in patients who had left atrial ablation with or without prior segmental ablation.
Predictors of recurrent symptomatic PAF were left atrial diameter and use of segmental ostial ablation (P<0.01)
Sponsor
The Ellen and Robert Thompson Atrial Fibrillation Research Fund
Trial Status: Completed
Review written by Amin Al-Ahmad, MD
