4P Study: Predictive Quality With Painfree Therapies

Completed

• Conditions: Cardiac Arrhythmias

• Registration Number: NCT01509378
• Lead Sponsor: Medtronic Bakken Research Center

Brief 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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-13
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients having an indication for a Protecta ICD or CRT-D device, or later market released ICD (first implant, replacement, or upgrade)
• Patients monitored with the Carelink monitoring system
• Patients having signed the patient informed consent form
• Patients older than 18 years

Exclusion Criteria

• Patients younger than 18 years of age
• Patients with a life expectancy of less than 24 months
• Females, pregnant and of child bearing potential
• Patients participation to another concomitant trial
• Patients unable or not willing to provide a signed patient informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of successful and non successful therapies	24 months follow up	First assessment and analysis of therapy efficacy and appropriate detection and classification

Secondary Outcome Measures

Name	Time	Method
All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE)	24 months follow up
Number of device diagnostics alerts and device integrity alerts	24 months follow up	First assessment of alerts and classification

Trial Locations

Locations (10)

HUG - University Hospital Geneva; 🇨🇭 Geneva, GE, Switzerland

HFR - Hôpital Cantonal - Fribourg; 🇨🇭 Fribourg, FR, Switzerland

Kantonsspital St.Gallen; 🇨🇭 St.Gallen, SG, Switzerland

CHUV, Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, VD, Switzerland

Klinik Im Park - Zurich; 🇨🇭 Zurich, ZH, Switzerland

USZ - University Hospital Zurich; 🇨🇭 Zurich, ZH, Switzerland

University Hospital - Basel; 🇨🇭 Basel, BS, Switzerland

CardioCentro Ticino - Lugano; 🇨🇭 Lugano, TI, Switzerland

GZO Spital - Wetzikon; 🇨🇭 Wetzikon, ZH, Switzerland

Stadtspital TRIEMLI - Zurich; 🇨🇭 Zurich, ZH, Switzerland