UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050391 |
|---|---|
| Receipt number | R000057379 |
| Scientific Title | Evaluation of prognosis of treatment with catheter ablation for patients with arrhythmia-induced cardiomyopathy caused by atrial fibrillation |
| Date of disclosure of the study information | 2023/02/23 |
| Last modified on | 2026/08/25 15:55:43 |
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Basic information
Public title
Evaluation of prognosis of treatment with catheter ablation for patients with arrhythmia-induced cardiomyopathy caused by atrial fibrillation
Acronym
Prognosis of AIC after ablation
Scientific Title
Evaluation of prognosis of treatment with catheter ablation for patients with arrhythmia-induced cardiomyopathy caused by atrial fibrillation
Scientific Title:Acronym
Prognosis of AIC after ablation
Region
| Japan |
Condition
Condition
Atrial fibrillation and heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to explore the clinical outcomes in arrhythmia-induced cardiomyopathy patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiovascular death or hospitalization due to heart failure. Moreover, the composite endpoint was defined as cardiovascular death or hospitalization due to heart failure.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with AF and reduced LVEF (<50%) underwent initial AF ablation
Key exclusion criteria
patients with severe old myocardial infarction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tada |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
+81-776-61-8800
daisetsu@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Daisetsu |
| Middle name | |
| Last name | Aoyama |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
+81-776-61-8800
Homepage URL
daisetsu@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
University of Fukui
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
University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel
+81-776-61-8800
daisetsu@u-fukui.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Heart Vessels. 2024 Mar;39(3):240-251. doi: 10.1007/s00380-023-02329-7. Epub 2023 Oct 23.
Publication of results
Partially published
Result
URL related to results and publications
Heart Vessels. 2024 Mar;39(3):240-251. doi: 10.1007/s00380-023-02329-7. Epub 2023 Oct 23.
Number of participants that the trial has enrolled
96
Results
During a median follow-up of 25 months, Kaplan-Meier analysis demonstrated that patients with AIC were associated with less frequent cardiovascular death (p=0.025) and hospitalization for worsening heart failure (p<0.001) than those without AIC. Freedom from AF recurrence was similar between the two groups (p=0.47).
Results date posted
| 2026 | Year | 08 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All patients underwent successful pulmonary vein isolation without any procedural complications, except for transient gastric hypomotility in 2 patients and cerebral infarction in 1 patient. Ninety-six patients (66.7years; 72 males, LVEF 39.3%) were included in our study and divided into the AIC group (n=67 [69.8%]) and non-AIC group (n=29 [30.2%]).
Participant flow
In total, 129 consecutive patients with AF and reduced LVEF (<50%) underwent initial AF ablation at our hospital from November 2014 to December 2021. Patients with an old myocardial infarction in >2 vessels and left ventricular hypertrophy, defined as a maximum LV wall thickness >13 mm on echocardiography, were excluded. AIC was defined as patients whose LVEF post-procedurally recovered to the normal range (>50%; LVEF recovery) and/or increased >20% from baseline by maintaining sinus rhythm after catheter ablation. Post-procedural LVEF was evaluated under maintained sinus rhythm between 3 and 12 months after initial catheter ablation. If patients experienced AF before follow-up echocardiographic measurements, echocardiographic parameters were evaluated while maintaining sinus rhythm from 3 to 12 months after the repeat procedure.
Adverse events
Nothing
Outcome measures
We found that 1) AIC was associated with freedom from the composite endpoint, cardiovascular death, and hospitalization for worsening heart failure after AF ablation; 2) LV end-diastolic diameter and CHA2DS2-VASc scores were independent predictors of AIC; 3) between patients with AIC with and without RAS inhibitors usage, clinical outcomes, including cardiovascular death, hospitalization for worsening heart failure, and AF recurrence, did not differ after the procedure; 4) though there were differences in baseline characteristics between patients with AIC with and without beta-blockers, no significant differences in clinical outcomes were observed between two groups; 5) serial change of pre- and post-procedural echocardiographic parameters, except for LV end-diastolic diameters, did not differ between those with and without RAS inhibitors or with and without beta-blocker usage.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses data from multiple hospital as follow; University of Fukui, Hikone Municipal Hospital, and Hikone Municipal Hospital.
Management information
Registered date
| 2023 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057379
