Examination of usefulness of iATP function (Proof of concept test in humans)

JRCT ID: jRCTs042210081

Registered date:07/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Fatal ventricular arrhythmia
• Date of first enrollment: 18/11/2021
• Target sample size: 48
• Study type: Interventional
• Intervention(s): Implantable cardioverter-defibrillator transplantation is performed for fatal ventricular arrhythmia, and iATP and conventional ATP are performed in the treatment.

Outcome(s)

• Primary Outcome: Validity of iATP settings automatically calculated by ICD

Secondary Outcome

1) The following comparison between the conventional ATP group and the iATP group (details of the success rate of ventricular tachycardia arrest by A-1 ATP and the failure of ventricular tachycardia arrest by A-2 ATP [increased heart rate of ventricular tachycardia, ventricular fibrillation] Activation, reinduction after VT stop, Pacing non capture, unsuccessful entry into VT circuit, unsuccessful entry into Termination zone])
2) Detailed examination of the intracardiac potential when VT is stopped (excitation propagation time, etc.)
3) Examination of predictors of success / failure in the first treatment
4) Examination of predictors of success / failure in treatment up to the final sequence

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients over 20 years old
2. Patients diagnosed with persistent ventricular tachycardia due to organic heart disease and scheduled to undergo electrophysiological examination and catheter ablation for therapeutic purposes
3. Patients who are scheduled to undergo or have already been implanted with an implantable cardioverter-defibrillator (Medtronic Cobalt XT) transplantation prior to ablation treatment

Exclude criteria

1. Patients less than 3 months after the onset of myocardial infarction
2. Patients who are dependent on catecholamines
3. Patients who are judged to be inappropriate for registration in this study by the investigator and the investigator

Related Information

• Primary Sponsor: Yoshihisa Naruse
• Secondary Sponsor: MEDTRONIC JAPAN CO., LTD.