UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007908
Receipt number R000009291
Scientific Title Inappropriate Shock Reduction with PARAD+ Rhythm Discrimination
Date of disclosure of the study information 2012/05/08
Last modified on 2016/05/09 08:58:40

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Basic information

Public title

Inappropriate Shock Reduction with PARAD+
Rhythm Discrimination

Acronym

ISIS-ICD Study

Scientific Title

Inappropriate Shock Reduction with PARAD+
Rhythm Discrimination

Scientific Title:Acronym

ISIS-ICD Study

Region

Japan North America Europe


Condition

Condition

Subjects indicated for ICD or CRT-D implantation.

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the reduction of patients experiencing inappropriate shocks in a general population implanted for primary or secondary prevention, with the PARAD+ enabled, during a 1 year follow-up.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

To demonstrate that 95% of patients implanted with PARAD+ algorithm enabled, are free from inappropriate shocks, compared to 92,5% of a general ICD population.

Key secondary outcomes

-to evaluate the percentage of appropriate shock (AS) episodes that are delivered over the 1-year follow-up.
-to classify (origin and number) the unscheduled visits, the needs of reprogramming, of re-intervention, and of medication changes, and to determine the correlation with the percentage of inappropriate shock episodes.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Program the study device as below within 1 month after implant.
Slow VT ON;
Rate ranges:150, Persistence ranges:30, Detection Criteria:PARAD+, Therapies:ATP1-ATP2(-Shocks(recommended))
VT ON;
Rate ranges:185, Persistence ranges:16, Detection Criteria:PARAD+, Therapies:
ATP1-Shocks
Fast VT ON;
Rate ranges:230, Persistence ranges:8, Detection Criteria:Rate + Stability, Therapies:ATP-Shocks
Fast VF ON;
Rate ranges:255, Persistence ranges:8, Detection Criteria:Rate, Therapies:Shocks

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 eligible for implantation (according to current accepted guidelines), or scheduled for implant (primo-implant, replacement, upgrade) with a Paradym/Paradym RF (CRT-D or DR-ICD) within the next 30 days, or has already been implanted within the last 30 days.
-Patient in sinus rhythm, or patients with paroxysmal atrial tachyarrhythmia or patients with persistent atrial tachyarrhythmia in whom a cardioversion is planned within three months
-Signed and dated informed consent.

Key exclusion criteria

-Any contraindication for ICD therapy
-Atrial lead not implanted
-Patient with permanent atrial tachyarrhythmia
-Post heart transplant or patients who are waiting for a heart transplant
-Patients implanted with a ventricular assist device (VAD)
-Already included in another clinical study that could confound the results of this study
-Inability to understand the purpose of the study or refusal to cooperate
-Unavailability for scheduled follow-up
-Less than 18 years of age
-Documented drug addiction or abuse that could interfere with study compliance
-Pregnancy
-Under guardianship

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Dr. Ricardo RUIZ GRANELL

Organization

Hospital Clinico Universitario

Division name

Arrhythmia Unit

Zip code


Address

Avda. Blasco Ibanez, 17, Valencia, COMUNIDAD VALENCIANA, 46010, Spain

TEL

03-6711-5263

Email

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


Email

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


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT01410552

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

小倉記念病院(福岡県)
Kokura Memorial Hospital


Other administrative information

Date of disclosure of the study information

2012 Year 05 Month 08 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

2011 Year 10 Month 13 Day

Date of IRB


Anticipated trial start date

2011 Year 10 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



Other

Other related information



Management information

Registered date

2012 Year 05 Month 08 Day

Last modified on

2016 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009291


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name