Title of Trial
Assessment of Atrioventricular Junction Ablation and DDDR Mode-Switching Pacemaker Versus Pharmacological Treatment in Patients With Severely Symptomatic Paroxysmal Atrial Fibrillation. A Randomized Controlled Study.
Date and Citation of Primary Publication(s) or References
Circulation 1997;96:2617-2624
Purpose of the Trial
To evaluate the quality of life and specific symptoms of individuals with symptomatic atrial fibrillation who receive an AV junction ablation and pacemaker as compared to those treated with medications
Study Categories
Ablation, Antiarrhythmic Drug, Atrial Fibrillation, Pacing
Patient Population
Patients with severely symptomatic paroxysmal atrial fibrillation
Inclusion Criteria
- Age > 50 years
- Severely symptomatic episodes of paroxysmal atrial fibrillation
- Failure of 3 or more antiarrhythmic drugs (including amiodarone) to control symptoms or maintain sinus rhythm
- Three or more episodes of PAF during previous six months
- Duration of episodes > 1 year
Exclusion Criteria
- Symptomatic bradycardia
- Need for pacemaker implant for other reasons
- Acute illness during previous 6 months
- Severe medical illness
Study Design
This was a randomized, multicenter trial in which patients were assigned to receive either a pacemaker and radiofrequency ablation of the atrioventricular junction versus medical therapy for symptomatic paroxysmal atrial fibrillation. Patients were followed for a total of six months and had quality of life and specific symptom questionnaires at enrollment as well as at the end of the study.
Primary Endpoints
The evaluation of quality of life and specific symptoms six months after randomization
Secondary Endpoints
- Intrapatient quality of life and specific symptom comparison
- Major clinical events during the follow-up period
- Objective assessment of cardiac performance at the beginning and end of the study
Baseline Characteristics: | | Ablation and PPM
(n=22) | Medical therapy (n=21) |
| Age | 66 ± 10 | 64 ± 10 |
| Gender (%Male) | 10 (45%) | 10 (48%) |
| CAD | 6 (27%) | 8 (38%) |
| Duration of PAF (years) | 9 ± 8 | 8 ± 5 |
| Heart rate during AF | 126 ± 21 | 120 ± 19 |
| Mean heart rate (holter) | 71 ± 8 | 74 ± 17 |
Number of prior
ineffective treatments | 4.5 ± 1.6 | 4.3 ± 1.1 |
Follow-up time: 6 months
Results
Pacemaker and ablation patients showed a significantly lower score in the living with heart failure questionnaire as well as a lower score in the symptoms of palpitations, effort dyspnea, exercise intolerance, and easy fatigue as compared with patients in the drug group. In terms of the intrapatient comparisons (between the time of enrollment and the end of follow-up), in the pacemaker and ablation group all variables decreased significantly except for chest discomfort. In the medication group, only the palpitation score decreased significantly. With regard to clinical events, there were more documented episodes of atrial fibrillation as well as more patients with permanent atrial fibrillation in the pacemaker and ablation group. When comparing the groups in terms of maximum heart rate during baseline stress test and follow-up stress test, the ablation & pacemaker group maximum heart rate decreased from 131 ± 30 bpm to 109 ± 16 bpm. In the groups treated with drugs, the maximum heart rate decreased from 126 ± 26 bpm to 117 ± 27 bpm. There was no significant change in the ejection fraction in both groups pre and post intervention.
Trial Status: Completed
Review written by: Amin Al-Ahmad, MD
