UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047023 |
|---|---|
| Receipt number | R000053533 |
| Scientific Title | Registry for Evaluating Healthy Life Expectancy and Long-term Outcomes After Catheter Ablation of Atrial Fibrillation in the very Elderly (REHEALTH AF study) |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2024/08/31 09:32:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Registry for Evaluating Healthy Life Expectancy and Long-term Outcomes After Catheter Ablation of Atrial Fibrillation in the very Elderly (REHEALTH AF study)
Acronym
Registry on Catheter Ablation of Atrial Fibrillation in Very Elderly Patients Over 80 Years
Scientific Title
Registry for Evaluating Healthy Life Expectancy and Long-term Outcomes After Catheter Ablation of Atrial Fibrillation in the very Elderly (REHEALTH AF study)
Scientific Title:Acronym
Registry on Catheter Ablation of Atrial Fibrillation in Very Elderly Patients Over 80 Years
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify health life expectancy and long-term outcomes after catheter ablation of atrial fibrillation in patients aged over 80years
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
660
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Department of Medicine, Nihon University School of Medicine
Division name
Division of Cardiology
Zip code
176-8310
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo, Japan
TEL
0339728111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Nagashima |
Organization
Department of Medicine, Nihon University School of Medicine
Division name
Division of Cardiology
Zip code
176-8310
Address
30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo, Japan
TEL
0339728111
Homepage URL
cocakochan@gmail.com
Sponsor or person
Institute
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital Clinical Research Center
Address
30-1 Oyaguchi-Kami Itabashi-Ku, Tokyo, Japan
Tel
03-3972-8111(8476)
komoda.nozomi@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本大学附属板橋病院（東京都）、日本大学病院（東京都）、金沢大学附属病院（石川県）、国立病院機構 金沢医療センター（石川県）、川口医療センター(埼玉県)、北里大学病院（神奈川県）、神戸大学附属病院（兵庫県）、国立病院機構 東京医療センター（東京都）、済生会熊本病院（熊本県）、自治医科大学附属さいたま医療センター（埼玉県）、順天堂大学附属順天堂病院（東京都）、湘南鎌倉総合病院（神奈川県）、心臓血管研究所付属病院（東京都）、聖マリアンナ医科大学病院（東京都）、帝京大学医学部附属病院（東京都）、東京医科大学病院（東京都）、東京慈恵医科大学附属病院（東京都）、東京慈恵医科大学葛飾医療センター（東京都）、東京女子医科大学(東京都)、東京大学医学部附属病院（東京都）、東京臨海病院（東京都）、東邦大学医療センター大森病院（東京都）、東邦大学医療センター大橋病院（東京都）、東北医科薬科大学病院（宮城県）、獨協医科大学埼玉医療センター（埼玉県）、富山県立中央病院（富山県）、日本医科大学付属病院（東京都）、弘前大学附属病院（青森県）、神戸大学医学部附属病院（兵庫県）、福岡赤十字病院（福岡県）、藤田医科大学病院（愛知県）、みなみ野病院（東京都）、小倉記念病院（福岡県）、東京慈恵医科大学柏病院（千葉県）、聖路加国際病院（東京都）、信州大学医学部附属病院（長野県）、札幌白石記念病院（北海道）、順天堂大学医学部附属静岡病院（静岡県）、昭和大学藤が丘病院（神奈川県）、大阪警察病院（大阪府）、順天堂大学医学部附属練馬病院（東京）、国際医療福祉大学成田病院（千葉県）、赤心クリニック（埼玉県）、TMGあさか医療センター（埼玉県）、赤羽中央総合病院（東京都）、板橋医師会病院（東京都）、春日部市立医療センター（埼玉県）、JCHO横浜中央病院（神奈川県）、北里研究所病院 循環器内科（東京都）、東埼玉総合病院（埼玉県）、JCHO相模野病院（神奈川県）、赤羽医院（栃木県）、善行団地石川医院（神奈川県）、木原循環器科内科医院（北海道）、東京慈恵会医科大学附属第三病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
660
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 01 | Day |
Other
Other related information
To investigate health life expectancy and prognosis in patients who do and don't undergo catheter ablation of atrial fibrillation
Management information
Registered date
| 2022 | Year | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053533
