UMIN-CTR Clinical Trial

Public title

Clinical Status Monitoring
in ICD Patients by PhD Function

Acronym

TUTOR STUDY

Scientific Title

Clinical Status Monitoring
in ICD Patients by PhD Function

Scientific Title:Acronym

TUTOR STUDY

Region

Japan

Europe

Condition

Patients with implanted ICD or CRT-D device

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare standard methods and PhD features to appraise the changes of patients' clinical status who with implanted PARADYM ICD or CRT-D.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

To demonstrate that PhD curves allow the evaluation of the patients' clinical status evolution with an agreement correlation of +67%, compared to a standard clinical method.

Key secondary outcomes

-The sensitivity and specificity of PhD functions to detect clinically relevant events,whether HF-related or not.
-The time between the PhD indication and the clinically relevant event occurrence.
-To classify (origin and number) the clinically relevant events, per patient group, and to determine a correlation with the percentage of ventricular pacing.
-To collect at least fifty (50) complete recordings for each group of patient (CRT-D, DR/VR)
-To evaluate and report the following incidence of adverse events (AEs) in the studied population, devices-related AEs with actual or potential effect on the patient, serious AEs not related to the device, mortality, and unanticipated AEs.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

-Patient eligible for implantation of an ICD or a CRT-D device according to current available guidelines
-Patient documented chronic HF (NYHA Class II to IV) at the time of enrollment
-Patient scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month
-Patient signed and dated informed consent

Key exclusion criteria

-Any contraindication for ICD therapy
-Abdominal implantation site
-Acute myocarditis
-Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
-Planned heart transplant
-Mechanical tricuspid valve
-Unable to perform the 6 minute Walking Test at time of enrollment
-Already included in another clinical study
-Life expectancy less than 13 months
-Inability to understand the purpose of the study or refusal to cooperate
-Inability or refusal to provide informed consent
-Under guardianship
-Age of less than 18 years
-Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)

Target sample size

558

Name of lead principal investigator

1st name
Middle name
Last name	Dr. Med. Johannes Sperzel

Organization

Kerckhoff Klinik

Division name

Cardiology

Zip code

Address

Benekestrasse 2-8, 61231 Bad Nauheim, Germany

TEL

+49-6032-996-2632

Email

m-nomura@jll.co.jp

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

NYK Tennoz Bldg. 25F, 2-2-20, Higashishinagawa, Shinagawa-ku, Tokyo, 140-0002

TEL

03-6711-5230

Homepage URL

Email

m-nomura@jll.co.jp

Institute

Sorin CRM SAS

Institute

Department

Personal name

Organization

Japan Lifeline Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT01170624

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

小倉記念病院 (福岡県)
Kokura Memorial Hospital

Date of disclosure of the study information

2011

Year

03

Month

04

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

Terminated

Date of protocol fixation

2009

Year

08

Month

18

Day

Date of IRB

Anticipated trial start date

2009

Year

09

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Multi-center and prospective study

After implantation at 1-month, 7-month and 13-month follow up, conduct device check, The Kansas City Cardiomyopathy Questionnairethe (KCCQ), 6-minute walk test, recording real time EGM and consulting medication. Fill the CRFs with the data and collect electric data file including memory data of the device.

Registered date

2011

Year

03

Month

04

Day

Last modified on

2015

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006159