Unique ID issued by UMIN | UMIN000007908 |
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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 |
Inappropriate Shock Reduction with PARAD+
Rhythm Discrimination
ISIS-ICD Study
Inappropriate Shock Reduction with PARAD+
Rhythm Discrimination
ISIS-ICD Study
Japan | North America | Europe |
Subjects indicated for ICD or CRT-D implantation.
Cardiology |
Others
NO
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.
Efficacy
Not applicable
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.
-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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
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
18 | years-old | <= |
Not applicable |
Male and Female
-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.
-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
1000
1st name | |
Middle name | |
Last name | Dr. Ricardo RUIZ GRANELL |
Hospital Clinico Universitario
Arrhythmia Unit
Avda. Blasco Ibanez, 17, Valencia, COMUNIDAD VALENCIANA, 46010, Spain
03-6711-5263
m-nomura@jll.co.jp
1st name | |
Middle name | |
Last name | Kenjiro Hara |
Japan Lifeline Co., Ltd.
Cardiac Rhythm Management Division
Tennoz Central Tower 6F, 2-2-24, Higashishinagawa, Shinagawa-ku, Tokyo, 140-0002, Japan
03-6711-5230
m-nomura@jll.co.jp
Sorin CRM SAS
Japan Lifeline Co., Ltd.
Profit organization
Japan
YES
NCT01410552
ClinicalTrials.gov
小倉記念病院(福岡県)
Kokura Memorial Hospital
2012 | Year | 05 | Month | 08 | Day |
Unpublished
No longer recruiting
2011 | Year | 10 | Month | 13 | Day |
2011 | Year | 10 | Month | 01 | Day |
2016 | Year | 03 | Month | 31 | Day |
2012 | Year | 05 | Month | 08 | Day |
2016 | Year | 05 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009291
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