4P Study: Predictive Quality With Painfree Therapies

Medtronic Cardiac Rhythm and Heart Failure200 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Cardiac Arrhythmias

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

University Hospital - Basel

Basel, Canton of Basel-City, Switzerland

HFR - Hôpital Cantonal - Fribourg

Fribourg, Canton of Fribourg, Switzerland

HUG - University Hospital Geneva

Geneva, Canton of Geneva, Switzerland

Outcomes

Primary Outcomes

Number of successful and non successful therapies

First assessment and analysis of therapy efficacy and appropriate detection and classification

Time frame: 24 months follow up

Secondary Outcomes

Number of device diagnostics alerts and device integrity alerts

First assessment of alerts and classification

Time frame: 24 months follow up

All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE)

Time frame: 24 months follow up

Data from ClinicalTrials.gov

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