Registry for Evaluating Healthy Life Expectancy and Long-term Outcomes After Catheter Ablation of Atrial Fibrillation in the very Elderly (REHEALTH AF study)

Conditions

Atrial Fibrillation

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.

2025-11-14

10.1016/j.jacep.2025.10.007

Registry for Evaluating Healthy Life Expectancy and Long-Term Outcomes after Catheter Ablation of Atrial Fibrillation in the Very Elderly (REHEALTH AF) study: rationale and design of a prospective, multicentre, observational, comparative study

Yasuo Okumura, Koichi Nagashima, Ryuta Watanabe, Katsuaki Yokoyama, Takeshi Kato et al. (71 authors)

BMJ Open2023-02-011 citations

10.1136/bmjopen-2022-068894

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: This study will enroll eligible patients if they are patients aged >= 80 years with nonvalvular AF and written consent is obtained, and 1) patients who are followed-up at general outpatient clinics, 2) those that are planning to undergo catheter ablation of AF after they are referred for catheter ablation from other hospitals, or 3) those who are not planning to undergo ablation according to their physicians' discretion or the patients' preference.

Exclusion criteria

Exclusion criteria: Patients not eligible for enrollment are 1) patients who have a history of ablation within 1 year, 2) those who have a clinical frailty scale >=7, 3) those who have severe dementia, 4) those who have severe valvular disease, 5) those with an active tumor, and 6) those who are judged inappropriate by the research director or research coordinator as subjects for this study.

Design outcomes

Primary

Measure	Time frame
Incidence of a stroke / TIA / systemic embolism, or other cardiovascular events (stroke / TIA / systemic embolism, cardiovascular events other than cardiovascular death, readmission for heart failure), major bleeding or all-cause death	—

Secondary

Measure	Time frame
Incidence rate of each of the following events 1) Stroke / TIA / systemic embolism 2) Cardiovascular events (stroke / TIA / systemic embolism, ischemic heart disease, cardiovascular death / sudden death, re-hospitalization for heart failure) 3) Major bleeding (ISTH criteria) 4) All-cause death 5) Clinically significant bleeding 6) Myocardial infarction, unstable angina 7) Heart failure requiring hospitalization and other cardiovascular events requiring hospitalization 8) Major bleeding or clinically significant bleeding 9) Cardiovascular death 10) Other deaths 11) Recurrence of atrial fibrillation after ablation 12) Pacemaker implantation 13) Fall 14) Bone fracture Changes in the following items from baseline to 1 year Weight Symptoms Clinical Frail Scale QALY evaluation by EQ-5D-5L MMSE Hemoglobin level, creatinine level, NT-proBNP Nutrition parameters (Serum albumin level, WBC [Peripheral blood lymphocyte count], total cholesterol level) Antiarrhythmic drugs, anticoagulants, antiplatelet drugs Primary and secondary endpoints will also be evaluated in limited cases of atrial fibrillation lasting less than 12, 24, and 36 months.	—

Measure

Time frame

Incidence rate of each of the following events 1) Stroke / TIA / systemic embolism 2) Cardiovascular events (stroke / TIA / systemic embolism, ischemic heart disease, cardiovascular death / sudden death, re-hospitalization for heart failure) 3) Major bleeding (ISTH criteria) 4) All-cause death 5) Clinically significant bleeding 6) Myocardial infarction, unstable angina 7) Heart failure requiring hospitalization and other cardiovascular events requiring hospitalization 8) Major bleeding or clinically significant bleeding 9) Cardiovascular death 10) Other deaths 11) Recurrence of atrial fibrillation after ablation 12) Pacemaker implantation 13) Fall 14) Bone fracture Changes in the following items from baseline to 1 year Weight Symptoms Clinical Frail Scale QALY evaluation by EQ-5D-5L MMSE Hemoglobin level, creatinine level, NT-proBNP Nutrition parameters (Serum albumin level, WBC [Peripheral blood lymphocyte count], total cholesterol level) Antiarrhythmic drugs, anticoagulants, antiplatelet drugs Primary and secondary endpoints will also be evaluated in limited cases of atrial fibrillation lasting less than 12, 24, and 36 months.

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Countries

Japan

Contacts

Public ContactKoichi Nagashima

Department of Medicine, Nihon University School of Medicine Division of Cardiology

cocakochan@gmail.com0339728111

Outcome results