This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Medtronic Bakken Research Center Identifier:
First received: January 10, 2012
Last updated: June 8, 2016
Last verified: June 2016

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.

Cardiac Arrhythmias

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 4P Study: A Prospective Study on Predictive Quality Preferring PainFree Therapies

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • 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:
  • Number of device diagnostics alerts and device integrity alerts [ Time Frame: 24 months follow up ]
    First assessment of alerts and classification

  • All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE) [ Time Frame: 24 months follow up ]

Enrollment: 200
Study Start Date: November 2011
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01509378

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
Principal Investigator: Martin Fromer, Professor CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
Study Director: Mayella Favre Medtronic (Suisse) SA
  More Information

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 )
Study First Received: January 10, 2012
Last Updated: June 8, 2016

Keywords provided by Medtronic Bakken Research Center:
ATP therapy
Rescue Shock therapy

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on August 18, 2017