Clinical trial NCT01509378: 4P Study: Predictive Quality With Painfree Therapies
Official title: 4P Study: A Prospective Study on Predictive Quality Preferring PainFree Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmias
Keywords: ICD
ATP therapy
Rescue Shock therapy
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2012-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICD patients primary and secondary prevention according to guidelines

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of successful and non successful therapies
timeFrame: 24 months follow up
Secondary outcomes:
measure: Number of device diagnostics alerts and device integrity alerts
timeFrame: 24 months follow up
measure: All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE)
timeFrame: 24 months follow up
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital - Basel
state: BS
city: Fribourg
country: Switzerland
facility: HFR - Hôpital Cantonal - Fribourg
state: FR
city: Geneva
country: Switzerland
facility: HUG - University Hospital Geneva
state: GE
city: St.Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
state: SG
city: Lugano
country: Switzerland
facility: CardioCentro Ticino - Lugano
state: TI
city: Lausanne
country: Switzerland
facility: CHUV, Centre Hospitalier Universitaire Vaudois
state: VD
city: Wetzikon
country: Switzerland
facility: GZO Spital - Wetzikon
state: ZH
city: Zurich
country: Switzerland
facility: Klinik Im Park - Zurich
state: ZH
city: Zurich
country: Switzerland
facility: Stadtspital TRIEMLI - Zurich
state: ZH
city: Zurich
country: Switzerland
facility: USZ - University Hospital Zurich
state: ZH
Study officials:
affiliation: CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
name: Martin Fromer, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Medtronic (Suisse) SA
name: Mayella Favre
role: STUDY_DIRECTOR
References: