4P Study: Predictive Quality With Painfree Therapies

Cardiac Arrhythmias Clinical Trial

— 4P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509378
• Other study ID #: CH KEK-ZH-Nr. 2011-0001/4
• Secondary ID: KEK-ZH Nr 2011/0
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: June 8, 2016
• Start date: November 2011
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Federal Office of Public HealthSwitzerland: Laws and standardsSwitzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Locations

Country	Name	City	State
Switzerland	University Hospital - Basel	Basel	BS
Switzerland	HFR - Hôpital Cantonal - Fribourg	Fribourg	FR
Switzerland	HUG - University Hospital Geneva	Geneva	GE
Switzerland	CHUV, Centre Hospitalier Universitaire Vaudois	Lausanne	VD
Switzerland	CardioCentro Ticino - Lugano	Lugano	TI
Switzerland	Kantonsspital St.Gallen	St.Gallen	SG
Switzerland	GZO Spital - Wetzikon	Wetzikon	ZH
Switzerland	Klinik Im Park - Zurich	Zurich	ZH
Switzerland	Stadtspital TRIEMLI - Zurich	Zurich	ZH
Switzerland	USZ - University Hospital Zurich	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of successful and non successful therapies	First assessment and analysis of therapy efficacy and appropriate detection and classification	24 months follow up	No
Secondary	Number of device diagnostics alerts and device integrity alerts	First assessment of alerts and classification	24 months follow up	No
Secondary	All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE)		24 months follow up	No