NCT01509378

4P Study: Predictive Quality With Painfree Therapies

4P Study: A Prospective Study on Predictive Quality Preferring PainFree Therapies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to characterize and quantify the relative effectiveness and contribution of implantable cardioverter defibrillator (ICD) therapy to the clinical outcomes under the conditions of daily practice. Swiss, multicenter, prospective, observational study.

Detailed description

The main role of ICD's is to stop potentially lethal ventricular tachyarrhythmias through overdrive pacing or shock, reducing the risk of sudden cardiac death. The device is programmed to detect episodes of arrhythmias, classify them according to the threat to patient, and deliver therapies to stop the arrhythmias. The actual focus of ICD programming has been the application of fast-pacing therapies (ATP or antitachy pacing) as first therapy before applying a shock as last resort to terminate an episode. Some studies have shown the high success rate of this method in decreasing the number of shock delivered to patients. Furthermore significant improvement has been done to improve the sensitivity and specificity of the detection and discrimination algorithm. This study will focus on the latest generation of device and their performance will be reviewed and analyzed by an Adjudication Board.

Conditions

• Cardiac Arrhythmias

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-01-13
• Last updated: 2025-07-03

Locations

10 sites across 1 country: Switzerland