UMIN-CTR Clinical Trial

Public title

The relationship between the timing right ventricular pacing and heart failure

Acronym

The relationship between the timing right ventricular pacing and heart failure

Scientific Title

The relationship between the timing right ventricular pacing and heart failure

Scientific Title:Acronym

The relationship between the timing right ventricular pacing and heart failure

Region

Japan

Condition

Patients who have been implanted dual-chamber pacemakers for sick sinus syndrome, without atrioventricular conduction disorder

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In the MOST sub-analysis comparing dual-chamber atrio-ventricular pacing and single-chamber ventricular pacing, it was reported that the occurrence of atrial fibrillation and heart failure hospitalization significantly increased according to ventricular pacing rate increasing. Based on such a result, Medtronic pacemaker is equipped with MVP (Managed Ventricular Pacing) mode as the ability to prioritize own QRS. MVP mode, which operates as AAI mode basically, automatically switches AAI to DDD mode if it senses that the atrio-ventricular conduction is disrupted completely, and reduced right ventricular pacing. When DDD mode is operated in patients with sinus node dysfunction who has been kept atrioventricular conduction, ventricular QRS wave is often consists of pacemaker spike and own natural QRS wave (fusion QRS), it is also possible that own natural QRS waveform has been paced. Pacing rates in previous studies has only been identified whether the pacing spike, the degree of fusion in systolic actually have not been taken into consideration, the relationship between the cardiac function and the timing of the pacing has not been studied yet. The purpose of this study is to verify the relationship between the timing right ventricular pacing and heart failure.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

BNP

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

MVP mode on -> short AV delay -> long AV delay

Interventions/Control_2

MVP mode on -> long AV delay -> short AV delay

Interventions/Control_3

short AV delay -> MVP mode on -> long AV delay

Interventions/Control_4

short AV delay -> long AV delay -> MVP mode on

Interventions/Control_5

long AV delay -> MVP mode on -> short AV delay

Interventions/Control_6

long AV delay -> short AV delay -> MVP mode on

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have been implanted with dual-chamber pacemakers for sick sinus syndrome.
Patients without impaired atrioventricular conduction.
Patients who have been followed up in Yokohama City University Hospital.

Key exclusion criteria

Patients who do not consent to participant of the study.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Toshiyuki Ishikawa

Organization

Yokohama city university hospital

Division name

CCU

Zip code

Address

Fukuura 3-9, Kanazawa-ku, Yokohama-shi, Kanagawa, Japan

TEL

045-787-2800

Email

Name of contact person

1st name
Middle name
Last name	Yuichiro Kimura

Organization

Yokohama city university hospital

Division name

CCU

Zip code

Address

Fukuura 3-9, Kanazawa-ku, Yokohama-shi, Kanagawa, Japan

TEL

045-787-2800

Homepage URL

Email

Institute

Yokohama city university hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

B120705005

Org. issuing International ID_1

Yokohama city university hospital

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜市立大学附属病院（神奈川県）

Date of disclosure of the study information

2012

Year

10

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2012

Year

10

Month

02

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

02

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

02

Day

Last modified on

2012

Year

10

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010589