Skip to main content
OpenTrials
Completed

NCT Number: NCT01509378

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Arrhythmias Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CardioCentro Ticino - Lugano, Lugano, Canton Ticino, Switzerland

Loading trial locations.

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of successful and non successful therapies

    Time frame: 24 months follow up

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

Secondary outcomes

  1. Number of device diagnostics alerts and device integrity alerts

    Time frame: 24 months follow up

    First assessment of alerts and classification

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

    Time frame: 24 months follow up

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: 4P

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2012
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.