Kokura Memorial Hospital
Kitakyushu, Fukuoka, 8028555, Japan
NCT Number: NCT05426785
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Kitakyushu, Fukuoka, 8028555, Japan
The enrolled patients are randomized to Treatment Group with setting to provide Antitachycardiac Pacing (ATP) multiple times at an early timing or Control Group with Long Detection setting for the conventional ATP, at latest 10 days after the implantation of the Implantable Cardioverter Defibrillator(ICD) system in the domestic centers to confirm the safety and efficacy of the setting for the early timing multiple ATP treatment in Japanese patients.
The follow-up is not pre-defined and the data (including the home monitoring data) is collected according to the site's standard outpatient schedule, but the data will be collected at the hospital visit for the initial appropriate or inappropriate shock therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Randomization also will be performed at latest 10 days after ICD implantation, and the specified device programming settings for the allocated group will be set after successful implantation of the investigational devices.
Time frame: From a minimum of 18 months to a maximum of 42 months
During the study duration(42 months: the enrollment period is 24 months plus the follow up period is 18 months from the Last Patient In(LPI)), to confirm that Treatment Group is the non-inferiority to the Control Group in terms of the time from randomized prescriptive settings to first shock with ICD device treatment, by Kaplan-Meier approach. The time frame of event evaluation is from a minimum of 18 months to a maximum of 42 months, since the study duration for each subject will differ according to the timing of enrollment.
Time frame: From a minimum of 18 months to a maximum of 42 months
During the study duration (42 months: the enrollment period is 24 months plus the follow up period is 18 months from the Last Patient In(LPI)), calculate the percentage of successful ATP treatment for all collected ATP treatment episodes. The definition of ATP success is that confirming by one beat of sinus rhythm or Atrial Pacing (in case of Atrial fibrillation, the electrical complex on an Electrocardiogram (ECG) related to the depolarization of the ventricles (QRS) or Ventricular Pacing) under the tachycardia detection rate. The time frame of event collections is from a minimum of 18 months to a maximum of 42 months, since the study duration for each subject will differ according to the timing of enrollment.
Time frame: From a minimum of 18 months to a maximum of 42 months
For all episodes collected during the study duration (42 months: the enrollment period is 24 months plus the follow up period is 18 months from the Last Patient In(LPI)), the time from the onset to the termination of the episode recorded in the ICD device is measured as the episode duration. The time frame of event collections is from a minimum of 18 months to a maximum of 42 months, since the study duration for each subject will differ according to the timing of enrollment.
Time frame: From a minimum of 18 months to a maximum of 42 months
During the study duration (42 months: the enrollment period is 24 months plus the follow up period is 18 months from the Last Patient In(LPI)), confirm the occurrence of cardiac mortality in all enrolled patients.The time frame of evaluation of cardiac mortality is from a minimum of 18 months to a maximum of 42 months, since the study duration for each subject will differ according to the timing of enrollment.
Biotronik SE & Co. KG
Industry
A Multicenter Prospective Randomized Study to Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing
Acronym: BIO|ATP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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