Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation (ACE-AF)

Assessment of the Effect of Catheter Ablation on Elderly Population With Atrial Fibrillation; a Randomized Controlled Study; The ACE-AF Study

ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure.

The study compares two established treatment strategies:

1. Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and
2. Optimized medical therapy without AF ablation (medications for rate and/or rhythm control; AV node ablation with pacemaker may be used if clinically indicated according to routine care).

Participants are randomized 1:1 to one of these strategies. All participants will receive an implantable loop recorder (a small heart rhythm monitor placed under the skin) to continuously track heart rhythm and measure AF burden over time.

The study has two co-primary outcomes assessed over 24 months:

1. a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and
2. patient-reported health-related quality of life (HRQoL), measured by the SF-36 "General Health" domain.

ACE-AF will provide evidence to guide treatment decisions for very elderly patients with symptomatic AF and help identify which patients benefit most from an ablation-based strategy compared with optimized medical therapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Elderly; Atrial Fibrillation Ablation; Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: Catheter Ablation for Atrial Fibrillation; Drug: Optimized Medical Therapy for Atrial Fibrillation; Device: Implantable Loop Recorder (ILR); Procedure: AV Node Ablation With Pacemaker implantation

Detailed Description

Background and Rationale

Atrial fibrillation (AF) is highly prevalent in very elderly individuals and is associated with substantial morbidity, including stroke, heart failure (HF), recurrent hospitalisations, polypharmacy, frailty, and impaired health-related quality of life (HRQoL). Catheter ablation is an established rhythm-control therapy in AF, but patients aged ≥78 years have been under-represented in randomised trials, and evidence on comparative effectiveness and safety versus optimised medical therapy in this age group remains limited. ACE-AF is designed to address this knowledge gap using a pragmatic randomised strategy design and continuous rhythm monitoring in both arms.

Study Design

ACE-AF is an investigator-initiated, multicentre, parallel-group, open-label randomised controlled trial conducted at seven Swedish university hospitals and collaborating centres in Denmark and Greece. Participants aged ≥78 years with symptomatic paroxysmal or persistent AF are randomised 1:1 to an ablation-based strategy or to optimised medical therapy without AF ablation.

Randomisation is performed centrally using an electronic system with allocation concealment until assignment, stratified by sex and Charlson comorbidity index.

Study Arms and Interventions

Arm A: Catheter ablation strategy Catheter ablation is performed according to contemporary clinical practice at experienced centres.

Pulmonary vein isolation (PVI) is prioritised as the primary ablation strategy. Energy source and tools are selected according to local practice and operator discretion, without restriction to a specific technology.

Periprocedural management (imaging, anticoagulation, anaesthesia strategy) follows local standards of care and the study protocol.

Arm B: Optimised medical therapy strategy (no AF ablation) Guideline-directed rate and/or rhythm control tailored to clinical need, including antiarrhythmic drugs and/or cardioversion when appropriate.

AV-node ablation with pacemaker implantation is permitted when clinically indicated, according to standard care.

Treatment optimisation and follow-up adhere to protocol-defined principles and local clinical routines.

Rhythm monitoring (both arms)

All participants receive an implantable loop recorder (ILR) to enable continuous rhythm monitoring, including quantification of AF burden and detection of clinically relevant arrhythmias over time (ILR programming per protocol).

Study Flow and Follow-up

Screening/Baseline (pre-randomisation/visit 1): informed consent; baseline clinical assessment including comorbidity profiling; baseline questionnaires and planned assessments per protocol.

Randomisation (1:1): central, concealed allocation; stratified by sex and Charlson comorbidity index.

Intervention phase (visit 2):

Ablation arm: catheter ablation performed as per protocol and site standards. Control arm: initiation/optimisation of medical therapy; AV-node ablation with pacing permitted if clinically indicated.

ILR implantation for continuous monitoring according to protocol-defined timing/workflow.

Follow-up visits: scheduled follow-up visits are performed at approximately 3, 12, 18 and 24 months after randomisation/intervention, with continuous ILR surveillance throughout follow-up. At follow-up, clinical events, adverse events, treatment changes, and patient-reported outcomes are collected according to protocol, and ILR rhythm summaries are reviewed.

Primary Outcomes (co-primary; multiplicity controlled)

Co-primary endpoints are evaluated over 24 months after randomisation and controlled for multiplicity using the Holm-Bonferroni procedure:

Composite clinical endpoint: all-cause mortality, stroke, serious bleeding, cardiac arrest, or hospitalisation due to heart failure within 24 months after randomisation.

HRQoL endpoint: effect on HRQoL measured by the SF-36 "General Health" domain.

Secondary Outcomes

Secondary outcomes include (as specified in the protocol):

AF burden and rhythm outcomes (ILR-derived): AF burden over time, recurrence patterns, and detection of clinically relevant rhythm events.

Healthcare utilisation: hospitalisations and AF/HF-related care contacts.

Patient-reported outcomes: symptom burden and HRQoL using validated instruments (including SF-36 and additional AF-related questionnaires per protocol).

Safety outcomes: procedure-related and treatment-related complications and serious adverse events.

Treatment pathways: need for cardioversion, medication escalation, AV-node ablation with pacing, and crossover patterns (as applicable).

Exploratory Objectives and Planned Subgroup/Modifier Analyses

Exploratory analyses will examine whether treatment effects differ by baseline characteristics and geriatric domains, including:

Frailty (e.g., Frailty Index and/or Clinical Frailty Scale).

Cognitive status (protocol-defined assessment).

Inflammatory biomarkers and overall comorbidity burden.

Sex (sex-disaggregated reporting and interaction analyses).

AF type (paroxysmal vs persistent).

Imaging substudy (selected Swedish sites): a predefined subgroup (e.g., at Karolinska and Linköping) planned for brain and/or cardiac imaging with MRI and/or CT per protocol to explore mechanistic associations.

Saliva sampling (optional subgroup): in a predefined subgroup, saliva is collected for exploratory biomarker/genetic analyses relevant to ageing and treatment response (separate consent; optional participation).

If subgroup analyses are underpowered, results will be reported as exploratory.

Sample Size and Statistical Considerations

The planned sample size is 282 participants, providing adequate power to detect clinically meaningful differences over 24 months, accounting for crossover and loss to follow-up. Primary analyses are performed according to the intention-to-treat principle. Multiplicity across the co-primary endpoints is addressed using a pre-specified Holm-Bonferroni approach.

Safety Oversight

Participant safety is overseen by an independent Data Monitoring Committee (DMC), comprising senior cardiology researchers independent of the study (Professor Eva Swahn, Professor Lars Lund, and Professor Johan Engdahl). Safety monitoring and adverse event reporting are conducted throughout the study according to the protocol.

Ethics, Regulatory, and Data Protection

The study has been approved by the Swedish Ethical Review Authority (Dnr 2025-02305-01; decision date 12 May 2025). Data are pseudonymised and processed in compliance with GDPR, with data captured in an electronic CRF (REDCap).

• Study Type: Interventional
• Enrollment (Estimated): 282
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanouil Charitakis, MD, PhD; Phone Number: 0046767877506; Email: emmanouil.charitakis@regionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital
    • Contact: Emmanouil Charitakis, MD, PhD; Phone Number: 0046767877506; Email: emmanouil.charitakis@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥78 years.
2. ECG-documented atrial fibrillation.
3. AF type: paroxysmal, persistent, or longstanding persistent AF.
4. Suitable candidate for catheter ablation according to ESC guidelines.
5. Charlson's comorbidity index ≤7.

Exclusion Criteria:

1. Left atrial (LA) dimension >55 mm, based on echocardiography within the previous year.
2. Acute coronary syndrome or coronary artery bypass surgery within the last 12 weeks.
3. Severe valvular heart disease (per ESC definitions) or congenital heart disease.
4. Prior surgical or catheter AF ablation procedure, or prior AV-node (atrioventricular nodal) ablation.
5. Contraindication to oral anticoagulation.
6. AF due to a reversible cause.
7. Medical condition likely to limit survival to <12 months.
8. Unable or unwilling to provide informed consent.
9. History of non-compliance with medical therapy.
10. BMI <18 or >37 kg/m².

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Catheter Ablation Strategy; Participants randomized to this arm will undergo catheter ablation for atrial fibrillation, with pulmonary vein isolation (PVI) prioritized as the primary ablation strategy. Energy source and tools are selected according to local practice and operator discretion (no restriction to a specific technology). Participants will also receive an implantable loop recorder (ILR) for continuous rhythm monitoring throughout follow-up. Additional medical therapy may be used as clinically indicated according to guideline-based care.	Procedure: Catheter Ablation for Atrial Fibrillation; Catheter ablation for symptomatic atrial fibrillation with pulmonary vein isolation (PVI) prioritized as the primary lesion set. Energy source and tools are selected according to local practice and operator discretion (no restriction to a specific technology), performed under routine standards of care at experienced centres.; Other Names: catheter ablation; pulmonary vein isolation; Drug: Optimized Medical Therapy for Atrial Fibrillation; Guideline-directed rate and/or rhythm control tailored to the participant's clinical condition, including rate-control medications and/or antiarrhythmic drugs and cardioversion when clinically appropriate. AF ablation is not performed as part of this strategy.; Other Names: Guideline-directed medical therapy; Rate control; Rhythm control; Device: Implantable Loop Recorder (ILR); Subcutaneous implantable loop recorder used for continuous rhythm monitoring and quantification of atrial fibrillation burden throughout follow-up. Implanted in all participants according to protocol-defined workflow.
Active Comparator: Optimized Medical Therapy (Rate/Rhythm control) ± AV Node Ablation + Pacing + ILR; Participants randomized to this arm will receive optimized guideline-directed medical therapy for atrial fibrillation without AF catheter ablation. Treatment may include rate control and/or rhythm control (including antiarrhythmic drugs and/or cardioversion when clinically appropriate). AV node ablation with pacemaker implantation is permitted when clinically indicated according to routine care. Participants will also receive an implantable loop recorder (ILR) for continuous rhythm monitoring throughout follow-up.	Drug: Optimized Medical Therapy for Atrial Fibrillation; Guideline-directed rate and/or rhythm control tailored to the participant's clinical condition, including rate-control medications and/or antiarrhythmic drugs and cardioversion when clinically appropriate. AF ablation is not performed as part of this strategy.; Other Names: Guideline-directed medical therapy; Rate control; Rhythm control; Procedure: AV Node Ablation With Pacemaker implantation; AV node ablation with permanent pacing may be performed when clinically indicated according to routine care, as part of the optimized medical therapy strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite clinical endpoint (all-cause mortality, stroke, serious bleeding, cardiac arrest, or heart failure hospitalization)	First part of the co-primary outcome: Proportion of participants with ≥1 of the following events within 24 months after intervention (visit 2): all-cause death, stroke, serious bleeding, cardiac arrest, or hospitalization for heart failure. Events will be adjudicated per protocol.	24 months after intervention (visit 2)
Change in RAND-36 General Health score	Second part of the co-primary outcome: Change from baseline in the RAND-36 "General Health" domain score at 24 months after the intervention (visit 2). Scores range 0-100; higher scores indicate better perceived health.	Baseline to 24 months after intervention (visit 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences of atrial fibrillation and atrial tachycardia burden (ILR-derived) between groups	Differences in percentage of time in atrial fibrillation and atrial tachycardia ("AF/AT burden") measured by continuous monitoring using an implantable loop recorder (ILR) between randomization groups.	From date of ILR implantation (intervention day, visit 2) up to 30 months after implantation.
Hospitalizations (all-cause and cardiovascular)	Number of hospital admissions, including cardiovascular/AF-related hospitalizations, collected from clinical records.	Up to 24 months after intervention
Serious adverse events and treatment-related complications	Serious adverse events (SAEs) and procedure-/treatment-related complications, including ablation-related and device-related complications, recorded and classified per protocol.	Up to 24 months after intervention
Additional patient-reported outcomes (AF symptoms / disease-specific HRQoL)	Symptom burden and AF-related quality of life assessed using validated questionnaires specified in the protocol (e.g., ASTA and/or AFEQT, as applicable).	Baseline and follow-up (3, 12, 18) through 24 months after intervention
Changes in Left atrial reservoir strain (LASr)	Left atrial function assessed as reservoir strain (LASr) by deformation imaging (speckle-tracking / deformation tracking, as per protocol). Reported as change from baseline to follow-up. Unit of measure: %	Up to 12 months after intervention (visit 2)
Cognitive function measured by Montreal Cognitive Assessment (MoCA)	MoCA total score assessed at follow-up visits. Reported as change from baseline	MoCA scores will be collected and assessed at baseline, 12, 18, and 24 months after intervention (visit 2).
Frailty score assessed by e-Frailty index	Frailty will be assessed using the e-Frailty index at baseline and follow-up. The outcome will be reported as a change in score from baseline to each follow-up time point.	Up to 24 months after intervention; visit 2 ( 12, 18, and 24 months)
Discrimination of a prediction model for the ACE-AF primary composite outcome	A multivariable prediction model (using baseline clinical variables and AI-derived features) will be developed to predict the time to first occurrence of the ACE-AF primary composite clinical outcome.	From baseline up to 24 months after intervention (visit 2).
Predictors of differential treatment effect on AF/AT burden	Baseline clinical variables (and AI-derived features, as available) will be evaluated as predictors of differential treatment effect on ILR-derived atrial fibrillation and atrial tachycardia (AF/AT) burden over follow-up.	From implantation (visit 2) up to 30 months after intervention
Participants with at least one event in the composite neurological endpoint (dementia, stroke, intracranial hemorrhage)	Composite neurological endpoint defined as the first occurrence of any of the following during follow-up: Incident dementia; Stroke (ischemic or hemorrhagic); Intracranial hemorrhage (including intracerebral hemorrhage and subarachnoid hemorrhage, per protocol definition) Results will be reported as number and percentage of participants with ≥1 composite event during follow-up.	Up to 24 months after intervention (visit 2).
Total healthcare costs per participant	Total direct healthcare costs per participant from intervention through follow-up, derived from healthcare utilization data (e.g., hospital inpatient/outpatient visits, procedures, emergency visits) and valued using standard regional/national tariffs per the health-economic analysis plan. Reported as mean/median cost per participant by group.	Up to 24 months after intervention (visit 2)
All-cause mortality, stroke/TIA, serious bleeding, cardiac arrest, hospitalization due to heart failure analyzed separately		Up to 24 months after intervention
Incident dementia	Proportion of participants with a new diagnosis of dementia during follow-up, based on predefined diagnostic criteria and/or registry/medical record confirmation.	Up to 24 months after intervention (visit 2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discrimination of an inflammation proteomics-based prediction model for the ACE-AF primary composite outcome	A predefined subgroup of patients included in the County of Stockholm and Östergotland will be analyzed using a targeted inflammation proteomics panel. A prespecified inflammation proteomics score will be computed from the panel. The score combined with baseline clinical covariates will be used to develop a prediction model for time to first occurrence of the ACE-AF primary composite outcome event.	Up to 24 months after intervention (visit 2).
Correlation between change in Epicardial fat and the combined AF/AT burden	Correlation between CT-derived Epicardial fat volume around LA the combined AF/AT burden measured by ILR through follow-up.	From implantation (visit 2) up to 24 months after the intervention
Discrimination of a saliva proteomics-based prediction model for the primary composite outcome	In a predefined subgroup providing separate consent, saliva samples will be analyzed using a proteomics platform. A prespecified salivary proteomics score will be used to develop a prediction model for the first occurrence of the study primary composite outcome event from baseline.	Baseline through 24 months after intervention
Change from baseline in oral health-related quality of life (OHIP-14 total score)	Patient-reported oral health-related quality of life measured using the Swedish version of the Oral Health Impact Profile (OHIP-14). The outcome will be reported as change from baseline in OHIP-14 total score.	Up to 12 months after baseline visit

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: University Hospital, Linkoeping; University Hospital, Gentofte, Copenhagen; Lund University Hospital; University Hospital, Umeå; Uppsala University Hospital; Onassis Cardiac Surgery Centre; Dept of Cardiology, Örebro University Hospital, Sweden; Sahlgrenska University Hospital

Publications and helpful links

General Publications

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• 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.
• Blomstrom-Lundqvist C, Gizurarson S, Schwieler J, Jensen SM, Bergfeldt L, Kenneback G, Rubulis A, Malmborg H, Raatikainen P, Lonnerholm S, Hoglund N, Mortsell D. Effect of Catheter Ablation vs Antiarrhythmic Medication on Quality of Life in Patients With Atrial Fibrillation: The CAPTAF Randomized Clinical Trial. JAMA. 2019 Mar 19;321(11):1059-1068. doi: 10.1001/jama.2019.0335.
• Orwelius L, Nilsson M, Nilsson E, Wenemark M, Walfridsson U, Lundstrom M, Taft C, Palaszewski B, Kristenson M. The Swedish RAND-36 Health Survey - reliability and responsiveness assessed in patient populations using Svensson's method for paired ordinal data. J Patient Rep Outcomes. 2017;2(1):4. doi: 10.1186/s41687-018-0030-0. Epub 2018 Feb 7.
• Friberg L, Bergfeldt L. Atrial fibrillation prevalence revisited. J Intern Med. 2013 Nov;274(5):461-8. doi: 10.1111/joim.12114. Epub 2013 Aug 7.
• Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.
• Tzeis S, Gerstenfeld EP, Kalman J, Saad EB, Shamloo AS, Andrade JG, Barbhaiya CR, Baykaner T, Boveda S, Calkins H, Chan NY, Chen M, Chen SA, Dagres N, Damiano RJ, De Potter T, Deisenhofer I, Derval N, Di Biase L, Duytschaever M, Dyrda K, Hindricks G, Hocini M, Kim YH, la Meir M, Merino JL, Michaud GF, Natale A, Nault I, Nava S, Nitta T, O'Neill M, Pak HN, Piccini JP, Purerfellner H, Reichlin T, Saenz LC, Sanders P, Schilling R, Schmidt B, Supple GE, Thomas KL, Tondo C, Verma A, Wan EY. 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2024 Sep;21(9):e31-e149. doi: 10.1016/j.hrthm.2024.03.017. Epub 2024 Apr 8.
• Hirata S, Okumura Y, Nagashima K, Watanabe R, Yokoyama K, Matsumoto N, Kato T, Fukaya H, Hayashi H, Nakahara S, Shimizu W, Iwasaki YK, Fujimoto Y, Mukai Y, Ejima K, Otsuka T, Suzuki S, Murakami M, Kimura M, Harada M, Koyama J, Yamane T, Tokuda M, Takami M, Shoda M, Harada T, Nakajima I, Hiroshima K, Tanimoto K, Kumagai K, Okada A, Kobayashi H, Watari Y, Hatsuno M, Hayashi T, Tachibana E, Iso K, Sonoda K, Aizawa Y, Fukuoka R, Chikata A, Inoue M, Sakagami S, Minamiguchi H, Makino N, Ichikawa M, Haruta H, Hiro T, Okubo K, Arai M, Arima K, Kihara H, Miyanaga S, Fukuda Y, Oiwa K, Koyama Y, Kurihara T, Akabane M, Ishikawa N, Kusano K, Miyamoto K, Tabuchi H, Shiozawa T, Miyamoto K, Mase H, Murotani K. Catheter Ablation Outcomes and Life Expectancy in Very Elderly Atrial Fibrillation Patients: The REHEALTH AF Study. JACC Clin Electrophysiol. 2025 Nov 14:S2405-500X(25)00827-8. doi: 10.1016/j.jacep.2025.10.007. Online ahead of print.
• Akerstrom F, Hutter J, Charitakis E, Tabrizi F, Asaad F, Bastani H, Bourke T, Braunschweig F, Drca N, Englund A, Friberg L, Insulander P, Jonsson AH, Kenneback G, Paul-Nordin A, Sadigh B, Saluveer O, Saygi S, Schwieler J, Svennberg E, Tapanainen J, Turkmen Y, Jensen-Urstad M. Association between catheter ablation of atrial fibrillation and mortality or stroke. Heart. 2024 Jan 10;110(3):163-169. doi: 10.1136/heartjnl-2023-322883.
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• 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.
• Santangeli P, Di Biase L, Mohanty P, Burkhardt JD, Horton R, Bai R, Mohanty S, Pump A, Gibson D, Couts L, Hongo R, Beheiry S, Natale A. Catheter ablation of atrial fibrillation in octogenarians: safety and outcomes. J Cardiovasc Electrophysiol. 2012 Jul;23(7):687-93. doi: 10.1111/j.1540-8167.2012.02293.x. Epub 2012 Apr 11.
• Tabaja C, Younis A, Santangeli P, Madden R, Taigen T, Farwati M, Hayashi K, Braghieri L, Rickard J, Klein BM, Paul A, Dresing TJ, Martin DO, Bhargava M, Kanj M, Sroubek J, Nakagawa H, Saliba WI, Wazni OM, Hussein AA. Catheter ablation of atrial fibrillation in elderly and very elderly patients: safety, outcomes, and quality of life. J Interv Card Electrophysiol. 2024 Aug;67(5):1083-1092. doi: 10.1007/s10840-023-01659-w. Epub 2023 Oct 17.
• Marinigh R, Lip GY, Fiotti N, Giansante C, Lane DA. Age as a risk factor for stroke in atrial fibrillation patients: implications for thromboprophylaxis. J Am Coll Cardiol. 2010 Sep 7;56(11):827-37. doi: 10.1016/j.jacc.2010.05.028.

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): September 1, 2034

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: atrial fibrillation; elderly; Health-related quality of life; catheter ablation; rate control; Randomized controlled study; implantable loop recorder; rhtyhm control
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Circulatory and Respiratory Physiological Phenomena; Physical Examination; Ablation Techniques; Radiofrequency Ablation; Radiofrequency Therapy; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Catheter Ablation; Heart Rate
• Other Study ID Numbers: 2025-02305-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) sharing has not yet been finalised. The steering committee will define an IPD-sharing plan prior to (or in connection with) publication of the primary results, with the intention to enable data access under controlled conditions for qualified researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No