Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT00273195
Brief Summary:
People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm.
The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device. A feature of this device allows it to send small, painless electrical impulses (Anti-tachycardia pacing or ATP) to the heart instead of shocking it out of a rhythm that is too fast. Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock to the heart can feel like a punch in the chest. This device also allows the heart to beat on its own when it can and helping it (by pacing, or sending it electrical signals) when it needs help. This feature is important because previously studies have shown that pacing the heart too often can increase the risk for heart failure or for atrial fibrillation (having too rapid of heart beats in the atrium).
This study is now complete and the device has since been approved by the FDA.
Study:
NCT00273195
Study Brief:
Protocol Section:
NCT00273195