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4P Study: Predictive Quality With Painfree Therapies (4P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01509378
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : June 9, 2016
Information provided by (Responsible Party):
Medtronic Bakken Research Center

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.

Condition or disease
Cardiac Arrhythmias

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 4P Study: A Prospective Study on Predictive Quality Preferring PainFree Therapies
Study Start Date : November 2011
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICD patients primary and secondary prevention according to guidelines

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01509378

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University Hospital - Basel
Basel, BS, Switzerland, 4031
HFR - Hôpital Cantonal - Fribourg
Fribourg, FR, Switzerland, 1708
HUG - University Hospital Geneva
Geneva, GE, Switzerland, 1211
Kantonsspital St.Gallen
St.Gallen, SG, Switzerland, 9007
CardioCentro Ticino - Lugano
Lugano, TI, Switzerland, 6900
CHUV, Centre Hospitalier Universitaire Vaudois
Lausanne, VD, Switzerland, 1011
GZO Spital - Wetzikon
Wetzikon, ZH, Switzerland, 8620
Klinik Im Park - Zurich
Zurich, ZH, Switzerland, 8038
Stadtspital TRIEMLI - Zurich
Zurich, ZH, Switzerland, 8063
USZ - University Hospital Zurich
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
Medtronic Bakken Research Center
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Principal Investigator: Martin Fromer, Professor CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
Study Director: Mayella Favre Medtronic (Suisse) SA

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Responsible Party: Medtronic Bakken Research Center Identifier: NCT01509378     History of Changes
Other Study ID Numbers: CH KEK-ZH-Nr. 2011-0001/4
KEK-ZH Nr 2011/0001/4 ( Other Identifier: Zurich University Hospital - Switzerland )
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Keywords provided by Medtronic Bakken Research Center:
ATP therapy
Rescue Shock therapy
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes