drugset / Trial / NCT00911508
Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Completed
2204 enrolled
Mayo Clinic
Abbott Medical Devices · collabBiosense Webster, Inc. · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF.
Timeline
- Start
- 2009-11-13
- Primary completion
- 2017-12-31
- Completion
- 2017-12-31
Publications
- Li W, Sudell M, Chen Y, Zhao M, Kelson M, Gupta D, Zheng Y, Packer DL, Meng Y, Lip GYH. Latent Class Analysis to Identify Phenotype-Specific Treatment Effects of Catheter Ablation Versus Drug Therapy in Patients with Atrial Fibrillation: A Secondary Analysis of the CABANA Trial. Heart Rhythm. 2026 Jul 8:S1547-5271(26)02540-3. doi: 10.1016/j.hrthm.2026.07.008. Online ahead of print.
- Zhao M, Chen Y, Li M, Jiang C, Wang Z, Liu H, He L, Sang C, Du X, Dong J, Packer DL, Ma C, Lip GYH. Impact of diagnosis to ablation time on clinical outcomes in patients with atrial fibrillation: post hoc analysis of the CABANA trial. BMC Med. 2026 Jan 12;24(1):81. doi: 10.1186/s12916-026-04615-3.
- Wu Q, Wang L, Li Y, Liang Z, Li Q, Liu X, Yin Y, Liu Y, Hu Z, Gao H, Zhang T, Wang Y. Prognostic impact of mitral regurgitation in elderly patients with atrial fibrillation: results from the CABANA trial. Open Heart. 2025 Nov 27;12(2):e003478. doi: 10.1136/openhrt-2025-003478.
- Chen Y, Soler-Espejo E, Zhao M, Li W, Liu H, Gue Y, McDowell G, Packer DL, Lip GYH. Association between comorbidity burden and outcomes of catheter ablation vs. medical therapy for atrial fibrillation: insights from the CABANA trial. Europace. 2025 Dec 1;27(12):euaf292. doi: 10.1093/europace/euaf292.
- Wang Z, Wu Y, Jiang C, He L, Zhou N, Sang C, Dong J, Ma C. Catheter Ablation vs Drug Therapy in Patients With Atrial Fibrillation and Nonmodifiable Recurrence Risk Factors: A Secondary Analysis of the CABANA Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2528124. doi: 10.1001/jamanetworkopen.2025.28124.
- Zhang J, Wang L, Li Y, Li Q, Liu X, Weng S, Yin Y, Liang Z, Zhang T, Wang Y. Atrial fibrillation phenotypes identified through cluster analysis in the CABANA study. Int J Cardiol. 2025 Nov 1;438:133606. doi: 10.1016/j.ijcard.2025.133606. Epub 2025 Jul 9.
- Martens P, Augusto SN Jr, Erzeel J, Pison L, Mullens W, Tang WHW. Effects of Atrial Fibrillation Ablation for Heart Failure With Preserved Ejection Fraction: Insights From CABANA. JACC Heart Fail. 2025 May;13(5):785-794. doi: 10.1016/j.jchf.2025.01.029. Epub 2025 Apr 16.
- Bunch TJ, Poole JE, Silverstein AP, Lee KL, Al-Khalidi HR, Hindricks G, Romanov A, Pokushalov E, Bahnson TD, Daniels MR, Piccini JP, Mark DB, Packer DL; CABANA Investigators. Prognostic Impact of Sinus Rhythm in Atrial Fibrillation Patients: Separating Rhythm Outcomes From Randomized Strategy Findings From the CABANA Trial. Circ Arrhythm Electrophysiol. 2024 May;17(5):e012697. doi: 10.1161/CIRCEP.123.012697. Epub 2024 Apr 17.
- Cappato R, Mark DB, Silverstein AP, Noseworthy PA, Bonitta G, Poole JE, Piccini JP, Bahnson TD, Daniels MR, Al-Khalidi HR, Lee KL, Packer DL; CABANA Investigators. Regional differences in outcomes with ablation versus drug therapy for atrial fibrillation: Results from the CABANA trial. Am Heart J. 2024 Apr;270:103-116. doi: 10.1016/j.ahj.2024.01.009. Epub 2024 Feb 1.
- Zeitler EP, Li Y, Silverstein AP, Russo AM, Poole JE, Daniels MR, Al-Khalidi HR, Lee KL, Bahnson TD, Anstrom KJ, Packer DL, Mark DB; CABANA Investigators. Effects of Ablation Versus Drug Therapy on Quality of Life by Sex in Atrial Fibrillation: Results From the CABANA Trial. J Am Heart Assoc. 2023 Feb 7;12(3):e027871. doi: 10.1161/JAHA.122.027871. Epub 2023 Jan 23.
- Monahan KH, Bunch TJ, Mark DB, Poole JE, Bahnson TD, Al-Khalidi HR, Silverstein AP, Daniels MR, Lee KL, Packer DL; CABANA Investigators. Influence of atrial fibrillation type on outcomes of ablation vs. drug therapy: results from CABANA. Europace. 2022 Oct 13;24(9):1430-1440. doi: 10.1093/europace/euac055.
- Bahnson TD, Giczewska A, Mark DB, Russo AM, Monahan KH, Al-Khalidi HR, Silverstein AP, Poole JE, Lee KL, Packer DL; CABANA Investigators. Association Between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: Results From the CABANA Trial. Circulation. 2022 Mar 15;145(11):796-804. doi: 10.1161/CIRCULATIONAHA.121.055297. Epub 2021 Dec 22.
- Thomas KL, Al-Khalidi HR, Silverstein AP, Monahan KH, Bahnson TD, Poole JE, Mark DB, Packer DL; CABANA Investigators. Ablation Versus Drug Therapy for Atrial Fibrillation in Racial and Ethnic Minorities. J Am Coll Cardiol. 2021 Jul 13;78(2):126-138. doi: 10.1016/j.jacc.2021.04.092.
- Rettmann ME, Holmes DR 3rd, Monahan KH, Breen JF, Bahnson TD, Mark DB, Poole JE, Ellis AM, Silverstein AP, Al-Khalidi HR, Lee KL, Robb RA, Packer DL; CABANA Imaging Investigators. Treatment-Related Changes in Left Atrial Structure in Atrial Fibrillation: Findings From the CABANA Imaging Substudy. Circ Arrhythm Electrophysiol. 2021 May;14(5):e008540. doi: 10.1161/CIRCEP.120.008540. Epub 2021 Apr 13.
- Packer DL, Piccini JP, Monahan KH, Al-Khalidi HR, Silverstein AP, Noseworthy PA, Poole JE, Bahnson TD, Lee KL, Mark DB; CABANA Investigators. Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial. Circulation. 2021 Apr 6;143(14):1377-1390. doi: 10.1161/CIRCULATIONAHA.120.050991. Epub 2021 Feb 8.
- Russo AM, Zeitler EP, Giczewska A, Silverstein AP, Al-Khalidi HR, Cha YM, Monahan KH, Bahnson TD, Mark DB, Packer DL, Poole JE; CABANA Investigators. Association Between Sex and Treatment Outcomes of Atrial Fibrillation Ablation Versus Drug Therapy: Results From the CABANA Trial. Circulation. 2021 Feb 16;143(7):661-672. doi: 10.1161/CIRCULATIONAHA.120.051558. Epub 2021 Jan 27.
- Poole JE, Bahnson TD, Monahan KH, Johnson G, Rostami H, Silverstein AP, Al-Khalidi HR, Rosenberg Y, Mark DB, Lee KL, Packer DL; CABANA Investigators and ECG Rhythm Core Lab. Recurrence of Atrial Fibrillation After Catheter Ablation or Antiarrhythmic Drug Therapy in the CABANA Trial. J Am Coll Cardiol. 2020 Jun 30;75(25):3105-3118. doi: 10.1016/j.jacc.2020.04.065.
- Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL; CABANA Investigators. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1261-1274. doi: 10.1001/jama.2019.0693.
- Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KH, Daniels MR, Bahnson TD, Poole JE, Rosenberg Y, Lee KL, Packer DL; CABANA Investigators. Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1275-1285. doi: 10.1001/jama.2019.0692.
- Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Moretz K, Poole JE, Mascette A, Rosenberg Y, Jeffries N, Al-Khalidi HR, Lee KL; CABANA Investigators. Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial: Study Rationale and Design. Am Heart J. 2018 May;199:192-199. doi: 10.1016/j.ahj.2018.02.015. Epub 2018 Mar 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amiodarone | Small molecule | 200 mg | — |
| Comparator | Amiodarone | Small molecule | 400 mg | — |
| Comparator | Atenolol | Other / unclassified | 50 mg | — |
| Comparator | Atenolol | Other / unclassified | 100 mg | — |
| Comparator | Carvedilol | Other / unclassified | 6.25 mg | — |
| Comparator | Carvedilol | Other / unclassified | 25 mg | — |
| Comparator | Digoxin | Other / unclassified | 0.125 mg | — |
| Comparator | Digoxin | Other / unclassified | 0.25 mg | — |
| Comparator | Diltiazem | Small molecule | 180 mg | — |
| Comparator | Diltiazem | Small molecule | 240 mg | — |
| Comparator | Dofetilide | Small molecule | 500 ug | — |
| Comparator | Dofetilide | Small molecule | 1000 ug | — |
| Comparator | Dronedarone | Small molecule | 800 mg | — |
| Comparator | Metoprolol | Other / unclassified | 50 mg | — |
| Comparator | Metoprolol | Other / unclassified | 100 mg | — |
| Comparator | Propranolol | Small molecule | 40 mg | — |
| Comparator | Propranolol | Small molecule | 80 mg | — |
| Comparator | Quinidine | Small molecule | 600 mg | — |
| Comparator | Quinidine | Small molecule | 900 mg | — |
| Comparator | Verapamil | Other / unclassified | 180 mg | — |
| Comparator | Verapamil | Other / unclassified | 240 mg | — |
| Comparator | acebutolol | Small molecule | 200 mg | — |
| Comparator | acebutolol | Small molecule | 300 mg | — |
| Comparator | flecainide | Small molecule | 200 mg | — |
| Comparator | flecainide | Small molecule | 300 mg | — |
| Comparator | propafenone | Unknown | 450 mg | — |
| Comparator | propafenone | Unknown | 625 mg | — |
| Comparator | sotalol | Small molecule | 240 mg | — |
| Comparator | sotalol | Small molecule | 320 mg | — |