UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008259 |
|---|---|
| Receipt number | R000009726 |
| Scientific Title | Assessment of Comorbidities & Atrial Arrhythmia Burden in Dual-Chamber Paced Patients |
| Date of disclosure of the study information | 2012/06/26 |
| Last modified on | 2020/01/06 09:37:55 |
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Basic information
Public title
Assessment of Comorbidities & Atrial Arrhythmia Burden in Dual-Chamber Paced Patients
Acronym
EMERALD Study
Scientific Title
Assessment of Comorbidities & Atrial Arrhythmia Burden in Dual-Chamber Paced Patients
Scientific Title:Acronym
EMERALD Study
Region
| Japan | North America | Europe |
Condition
Condition
Patients with implanted dual-chamber Pacemakers
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence and evolution over-time of co-morbidities in a general dual-chamber pacemaker population through a 2-year follow-up.
Basic objectives2
Others
Basic objectives -Others
The study will particularly focus on the number of patients moving to persistent Atrial Fibrillation as a function of pacing mode, pacing sites, and cumulative %Ap & %Vp, in a general dual-chamber pacemaker population through a 2 year follow-up.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To demonstrate that patients with ventricular pacing under 40% have less risk to have persistent AF than patients with high ventricular pacing.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patient scheduled for implat(primo-implant, replacement, upgrade) with the study device within the next month or has already been implanted within the last two months.
- Patient has signed the consent to data treatment (according to the laws and regulations of the country in which the observation is performed)
Key exclusion criteria
1. Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
2. Permanent or persistent atrial tachyarrhythmia
3. Already included in another interventional clinical study
4. Life expectancy less than 24 months
5. Not available for routine follow-up visits.
6. Inability to understand the purpose of the study or refusal to cooperate
7. Under guardianship
8. Age of less than 18 years
9. Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
Target sample size
4290
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Maria Grazia BONGIORNI |
Organization
University Hospital of Pisa
Division name
Division of Cardiology
Zip code
Address
Via Roma, 67, Pisa, 56126, Italy
TEL
+39-050-993252
m-nomura@jll.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenjiro Hara |
Organization
Japan Lifeline Co., Ltd.
Division name
Cardiac Rhythm Management Division
Zip code
Address
Tennoz Central Tower 6F, 2-2-24, Higashishinagawa, Shinagawa-ku, Tokyo, 140-0002, Japan
TEL
03-6711-5230
Homepage URL
m-nomura@jll.co.jp
Sponsor or person
Institute
Sorin CRM SAS
Institute
Department
Personal name
Funding Source
Organization
Japan Lifeline Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01188356
Org. issuing International ID_1
Clinical Trials. gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横須賀共済病院(神奈川県)、横浜市立大学附属病院（神奈川県）、関西医科大学附属枚方病院（大阪府）
Yokosuka Kyosai Hospital, Yokohama City University Hospital, Kansai Medical University Hirakata Hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 26 | 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
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
| 2010 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
The follow-up data to be collected are of two types:
-The medical and clinical data to be collected in the case report forms.
-The electronic files containing device memory data which are saved automatically on the programmer upon device interrogation ("AIDA(+)" files).
Management information
Registered date
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009726
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
