SPARK Registry (High Power Registry)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1042200049

Enrollment

400

Registered

2020-10-08

Start date

2020-11-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Tachycardia, Heart Failure

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan, Korea

Contacts

Public ContactEiichiro Goto

Medtronic Japan

goto.eiichiro@medtronic.com+81-80-4441-9938

Outcome results