UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037362
Receipt No. R000041304
Scientific Title Titration of HOT balloon ablation strategy according to real time monitoring of pulmonary vein potentials.
Date of disclosure of the study information 2019/08/01
Last modified on 2019/07/13

* 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 Titration of HOT balloon ablation strategy according to real time monitoring of pulmonary vein potentials.
Acronym Titration of HOT balloon ablation strategy according to real time monitoring of pulmonary vein potentials.
Scientific Title Titration of HOT balloon ablation strategy according to real time monitoring of pulmonary vein potentials.
Scientific Title:Acronym Titration of HOT balloon ablation strategy according to real time monitoring of pulmonary vein potentials.
Region
Japan

Condition
Condition paroxysmal atrial fibrillation
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate real time PV monitoring and investigated the time to isolation guided optimal application strategy for HB based PV isolation in the acute phase.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Time to isolation (TTI) was determined by the complete disappearance of the PV potentials and/or its dissociation from LA electrical activity during HBA. We also evaluate the difference between TTI and Time to reach target temperature (TTRT).
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria symptomatic, drug-refractory paroxysmal AF
Key exclusion criteria The patients with a long left common trunk (>15mm) were excluded because of difficulty of individual energy application of each PVs.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Akio
Middle name
Last name Chikata
Organization Toyama Prefectural Central Hospital
Division name Division of Cardiology, Department of Internal Medicine
Zip code 930-8550
Address 2-2-78 Nishi-nagae, Toyama
TEL 076-424-1531
Email Akio.Chikata@gmail.com

Public contact
Name of contact person
1st name Akio
Middle name
Last name Chikata
Organization Toyama Prefectural Central Hospital
Division name Division of Cardiology, Department of Internal Medicine
Zip code 930-8550
Address 2-2-78 Nishi-nagae, Toyama
TEL 076-424-1531
Homepage URL
Email Akio.Chikata@gmail.com

Sponsor
Institute Toyama Prefectural Central Hospital
Institute
Department

Funding Source
Organization Toyama Prefectural Central Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toyama Prefectural Central Hospital
Address 2-2-78 Nishi-nagae, Toyama
Tel 076-424-1531
Email byoin@esp.pref.toyama.lg.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
2019 Year 08 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 34
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 Completed
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 06 Month 13 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We invested optimal ablation strategy according to time to isolation.

Management information
Registered date
2019 Year 07 Month 13 Day
Last modified on
2019 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041304

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.