4P Study: Predictive Quality With Painfree Therapies
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||4P Study: A Prospective Study on Predictive Quality Preferring PainFree Therapies|
- Number of successful and non successful therapies [ Time Frame: 24 months follow up ] [ Designated as safety issue: No ]First assessment and analysis of therapy efficacy and appropriate detection and classification
- Number of device diagnostics alerts and device integrity alerts [ Time Frame: 24 months follow up ] [ Designated as safety issue: No ]First assessment of alerts and classification
- All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE) [ Time Frame: 24 months follow up ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509378
|University Hospital - Basel|
|Basel, BS, Switzerland, 4031|
|HFR - Hôpital Cantonal - Fribourg|
|Fribourg, FR, Switzerland, 1708|
|HUG - University Hospital Geneva|
|Geneva, GE, Switzerland, 1211|
|St.Gallen, SG, Switzerland, 9007|
|CardioCentro Ticino - Lugano|
|Lugano, TI, Switzerland, 6900|
|CHUV, Centre Hospitalier Universitaire Vaudois|
|Lausanne, VD, Switzerland, 1011|
|GZO Spital - Wetzikon|
|Wetzikon, ZH, Switzerland, 8620|
|USZ - University Hospital Zurich|
|Zurich, ZH, Switzerland, 8091|
|Stadtspital TRIEMLI - Zurich|
|Zurich, ZH, Switzerland, 8063|
|Klinik Im Park - Zurich|
|Zurich, ZH, Switzerland, 8038|
|Principal Investigator:||Martin Fromer, Professor||CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland|
|Study Director:||Raymond Moser, Ph.D||Medtronic (Suisse) SA|