NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1042200049

Registered date:08/10/2020

SPARK Registry (High Power Registry)

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedVentricular Tachycardia, Heart Failure
Date of first enrollment02/11/2020
Target sample size400
Countries of recruitmentKorea,Japan
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeTo characterize the non-incidence of device-related complications after Cobalt XT implantation. To characterize the incidence of abnormal battery drain complications after implantation. To summarize the reasons and measures for system changes including removal of study devices. To evaluate the efficacy and safety of iATP for VT after 12 months. To assess stability 12 months after ASQ implantation. In addition, to evaluate safety information for adverse events and equipment failures through a 12-month follow-up period.
Secondary OutcomeThe ancillary objectives are descriptive in nature and are intended to gain additional information to further assess safety and performance (with a focus on the acute and chronic timeframe) of iATP and ASQ, and the patients implanted with Cobalt XT. There are no specific sample size requirements for the following ancillary objectives. The ancillary objectives are as follows: - Implant electrical summary - Characterization of the implant procedure - Total implant time - Lead implant success rate - Number of lead position changes - Final leadimplant location - Characterization of drug strategy prior, during, and after implant procedure - Characterization of patient profile - Indication - Demographics - Medical History - QOL

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. Patient is 20 years and older. 2. Patient or legally authorized representative provides written consent. 3. Patient will undergo de novo Cobalt XT implant and be treated with iATP. 4. Patient will be treated with ASQ if CRT-D.
Exclude criteria1. Patient is enrolled or registered in another clinical study without pre-approval from the Medtronic study manager. 2. Patient has a life expectancy of less than one year. 3. Patient is not expected to remain available for at least 1 year of follow-up visits.

Related Information

Contact

Public contact
Name Eiichiro Goto
Address Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo Tokyo Japan 108-0075
Telephone +81-80-4441-9938
E-mail goto.eiichiro@medtronic.com
Affiliation Medtronic Japan
Scientific contact
Name Masahiko Goya
Address 1-4-3 Mita, Minato-ku, Tokyo 108-8329 Japan Tokyo Japan 108-8329
Telephone +81-3-3451-8121
E-mail mgoyamd@yahoo.co.jp
Affiliation International University of Health and Welfare, Mita Hospital