4P Study: Predictive Quality With Painfree Therapies
4P
4P Study: A Prospective Study on Predictive Quality Preferring PainFree Therapies
2 other identifiers
observational
200
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2011
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 10, 2012
CompletedFirst Posted
Study publicly available on registry
January 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJuly 3, 2025
June 1, 2016
4.5 years
January 10, 2012
June 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of successful and non successful therapies
First assessment and analysis of therapy efficacy and appropriate detection and classification
24 months follow up
Secondary Outcomes (2)
Number of device diagnostics alerts and device integrity alerts
24 months follow up
All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE)
24 months follow up
Eligibility Criteria
ICD patients primary and secondary prevention according to guidelines
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiac Rhythm and Heart Failurelead
- Medtroniccollaborator
Study Sites (10)
University Hospital - Basel
Basel, Canton of Basel-City, 4031, Switzerland
HFR - Hôpital Cantonal - Fribourg
Fribourg, Canton of Fribourg, 1708, Switzerland
HUG - University Hospital Geneva
Geneva, Canton of Geneva, 1211, Switzerland
Kantonsspital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
CHUV, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011, Switzerland
GZO Spital - Wetzikon
Wetzikon, Canton of Zurich, 8620, Switzerland
Klinik Im Park - Zurich
Zurich, Canton of Zurich, 8038, Switzerland
Stadtspital TRIEMLI - Zurich
Zurich, Canton of Zurich, 8063, Switzerland
USZ - University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
CardioCentro Ticino - Lugano
Lugano, Canton Ticino, 6900, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Fromer, Professor
CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
- STUDY DIRECTOR
Mayella Favre
Medtronic (Suisse) SA
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2012
First Posted
January 13, 2012
Study Start
November 1, 2011
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
July 3, 2025
Record last verified: 2016-06