Table 1.
Summary of the included studies
| Study ID | NCT | Site | Type of AF | Population | Follow-up | Conclusion | Cardiac rhythm measurement | Endpoint definition | Energy type | Intervention group | Control group |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Biase et al. 2016 [19] | NCT00729911 | Multi-national | Persistent AF | Patients with congestive heart failure and an implanted device with persistent AF. | Two years | The study reported that for patients with heart failure and persistent AF, catheter ablation was superior to amiodarone in achieving long-term relieving of AF and reducing unplanned hospitalizations and mortality. | Remote monitoring with implanted devices and/or with device inspection at 3-, 6-, 12- and 24-months follow-up. | Recurrence of AF was defined as AF that lasted at least 30 s | Radiofrequency | Ablation + AADs for the first 3 months | Amiodarone (200 mg/d) |
| Forleo et al. 2009 [23] | NA | Italy | Paroxysmal [29] and persistent (41) | Type 2 diabetic patients with symptomatic paroxysmal or persistent AF for ≥ 6 months refractory to ≥ 1 class 1–3 AADs | One year | For those with type 2 diabetes, AF catheter ablation offered better outcomes than drug therapy, proving feasible, effective, and low-risk. | Holter ECG at 1, 3, and every 3 months thereafter or in case of occurrence of any clinical symptom. | AF recurrence was defined as any electrocardiographically confirmed episode of AF or atypical atrial flutter lasting > 30 s | Radiofrequency | Ablation + AADs for the first 3 months | Either as single drug or combination of oral flecainide (100 mg/12 hours), oral propafenone (150–300 mg/TID), oral sotalol at an initial dose of 80 mg/TID, and oral amiodarone (200 mg/d). |
| Jais et al. 2008 [26] | NCT00540787 | USA and France | Paroxysmal AF | Patients with paroxysmal AF resistant to at least 1 antiarrhythmic drug. | One year | The study revealed that catheter ablation was more effective in sustaining sinus rhythm and enhancing symptoms, exercise capacity, and quality of life compared to the use of antiarrhythmic medications. | 12-lead ECG and 24-hour Holter at baseline and 3, 6, and 12 months | Episodes qualified as AF if they lasted at least 3 min and were documented by ECG or reported by the patient as AF, even in the absence of ECG | Radiofrequency | Ablation | Amiodarone (200 mg/d), quinidine, disopyramide, flecainide, propafenone, cibenzoline, dofetilide, and sotalol (either alone or in combination) |
| Kuck et al. 2021 [25] | NCT01570361 | Multi-national | Paroxysmal AF | Patients with paroxysmal AF for more than two years and more than two episodes over the last six months, resistant to at least 1 antiarrhythmic drug. | Three years | Radiofrequency ablation was superior to AADs in delaying the progression from paroxysmal to persistent AF. | ECG were conducted at 3 and 6 months, and then at yearly intervals for 3 years. Weekly transtelephonic monitoring (TTM) began at 3 months, transitioning to monthly monitoring after 9 months until the 3-year visit, or whenever subjects experienced arrhythmic symptoms | Recurrence of AF was defined as AF that lasted at least 30 s for > 7 consecutive days or requiring termination by cardioversion after 48 h | Radiofrequency | Ablation | AADs according to current guidelines at the investigators’ discretion. |
| Mont et al. 2014 [21] | NCT00863213 | Spain | Persistent AF | Patients with persistent AF, requiring electrical or pharmacological cardioversion and refractory to at least one class I or class III antiarrhythmic drug. | One year | Catheter ablation was superior to medical therapy for the maintenance of sinus rhythm in patients with persistent AF at 12-month follow-up |
12-lead ECG at 1, 3, 6, and 12 months and 24-h Holter monitor was performed at 6 and 12 months. |
Recurrence of AF was defined as AF that lasted at least 30 s | Radiofrequency | Ablation + AADs for the first 3 months | Class III drugs (amiodarone) were recommended for patients with structural cardiomyopathy and class Ic (flecainide) plus diltiazem or b-blockers otherwise |
| Morillo et al. 2014 [20] | NCT00392054 | Multi-national | Paroxysmal AF | Patients with recurrent paroxysmal AF lasting over 30 s, at least one documented episode 6 months prior, and no prior antiarrhythmic drug treatment. | Two years | For those with untreated paroxysmal AF, radiofrequency ablation resulted in fewer recurring atrial tachyarrhythmias at 2 years compared to antiarrhythmic drugs, but both groups still experienced frequent recurrence. |
Continuous remote monitoring (Using transtelephonic monitor system, patients were required to record and transmit symptomatic episodes of possible AF every week, and biweekly on Fridays throughout the follow-up period, regardless of symptoms) |
Recurrence of arrythmia is arrythmia lasting more than 30 s documented by ECG or transtelephonic monitor | Radiofrequency | Ablation + AADs for the first 3 months | Aِntiarrhythmic drugs was left to the discretion of the investigator, and dosages were based on guidelines |
| Nielsen et al. 2012 [28] | NCT00133211 | Denmark | Paroxysmal AF | Patient experienced at least two symptomatic episodes of atrial fibrillation within the past six months, with no episode lasting more than seven days. | Two years | Comparing radiofrequency ablation to antiarrhythmic drugs as first-line therapy for paroxysmal AF, they found no significant difference in overall AF burden over 2 years. | 7-day Holter-monitor recording at 3, 6, 12, 18, and 24 months. Patients were instructed to report palpitations or other symptoms to the study center between follow-up visits. | AF was defined as AF that lasted at least 1 min | Radiofrequency | Ablation + AADs for the first three months | Class IC agents such as flecainide (200 mg/day) or propafenone (600 mg/day). If contraindicated, Class III agents like amiodarone (200 mg/day) or sotalol (160 mg/day) are administered. No combination between class IC and class III was allowed |
| Oral et al. 2006 [30] | NA | Italy | Persistent AF | A patient experienced persistent atrial fibrillation for over six months without any intervening sinus rhythm episodes | One year | Patients with chronic atrial fibrillation could sustain sinus rhythm long-term through pulmonary-vein ablation, regardless of antiarrhythmic drugs or cardioversion effects. |
Continuous remote monitoring (Participants were monitored using LifeWatch, recording their heart rate at least five days a week for three minutes and whenever they had symptoms of AF) |
NA | Radiofrequency | Ablation + Amiodarone, 200 mg/day, orally for three months | Amiodarone, 200 mg/day, orally for three months + transthoracic cardioversions |
| Packer et al. 2019 [22] | NCT00911508 | Multi-national | Paroxysmal (42.9%) and persistent (47.2%) | Symptomatic patients with AF with 1 or more risk factors for stroke (hypertension, heart failure, history of stroke, diabetes, or other heart problems), with two or more episodes of paroxysmal AF or one episode of persistent AF within the past six months. | Four years | In patients with AF, the approach of catheter ablation didn’t notably decrease the main combined outcome of death, disabling stroke, severe bleeding, or cardiac arrest when compared to medical therapy. |
ECG event recorder to document symptomatic events, quarterly 24-hour autodetect, full-disclosure, real-time recordings and 96-hour Holter recordings every six months, regardless of symptoms. |
Recurrence of AF was defined as AF that lasted at least 30 s | NA | Ablation | AAD |
| Pappone et al. 2006 [27] | NCT00340314 | Italy | Paroxysmal AF | Patients with paroxysmal AF who have already failed AADs. | One year | CA was more successful than AAD for the prevention of atrial fibrillation with less complications. |
12-lead electrocardiogram (ECG) and 48-h Holter monitoring at 3-, 6-, and 12-months visits and Continuous remote monitoring (Participants were monitored using LifeWatch were asked to record their rhythm 1 to 3 times daily and whenever they experienced symptoms suggestive of AF) |
Recurrence of AF was defined as AF that lasted at least 30 s | Radiofrequency | Ablation + AADs for 6 weeks | Amiodarone (200 mg/day), flecainide (up to 300 mg/day), or sotalol (up to 320 mg/day), (either as single drugs or in combination) at the maximum tolerable doses |
| Wazni et al. 2005 [29] | NA | Italy and Germany | Paroxysmal AF | Patients had experienced monthly symptomatic AF episodes for at least 3 months. | One year | Pulmonary vein isolation was a viable initial option. | Event recorder monitoring was obtained after the 3-month period for patients with recurrences of symptoms and 24-hour Holter recording before discharge, as well as 3, 6, and 12 months after enrollment. Patients were also phoned once a month by phone. | Symptomatic or asymptomatic AF lasting more than 15 s during Holter or event monitoring | Radiofrequency | Ablation | Oral flecainide (100–150 mg) twice daily, propafenone (225–300 mg) 3 times daily, and sotalol (120–160 mg) twice daily. |
| Wilber et al. 2010 [24] | NCT00116428 | Multi-national | Paroxysmal AF | Patients with at least three symptomatic AF episodes within 6 months before randomization and not responding to at least one antiarrhythmic drug are eligible. | 9 months | In individuals with paroxysmal AF unresponsive to at least one antiarrhythmic drug, catheter ablation led to an extended duration until treatment failure compared to AADs over the 9-month follow-up period. | ECG were obtained at follow-up visits, and transtelephonic monitoring was performed for 9 months. Patients were required to transmit symptomatic cardiac episodes weekly, then monthly till the final visit. Holter was done at baseline and final visits. | NA | Radiofrequency | Ablation | Dofetilide, flecainide, propafenone, sotalol, or quinidine |
AF Atrial Fibrillation, NCT ClinicalTrials.gov Identifier (an alphanumeric code assigned to clinical trials), AADs Antiarrhythmic Drugs, NA not available