4P Study: Predictive Quality With Painfree Therapies

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01509378

Acronym

Enrollment

200

Registered

2012-01-13

Start date

2011-11-30

Completion date

2016-05-31

Last updated

2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmias

Keywords

ICD, ATP therapy, Rescue Shock therapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of successful and non successful therapies	24 months follow up	First assessment and analysis of therapy efficacy and appropriate detection and classification

Secondary

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

Countries

Switzerland

Outcome results