SPARK Registry (High Power Registry)

JRCT ID: jRCT1042200049

Registered date:08/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Ventricular Tachycardia, Heart Failure
• Date of first enrollment: 02/11/2020
• Target sample size: 400
• Countries of recruitment: Korea,Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: To 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 Outcome

The 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 maximum: Not applicable
• Gender: Both

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Goya Masahiko