Cardiac Arrhythmias4PNCT01509378
4P Study: Predictive Quality With Painfree Therapies
An observational study of Cardiac Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- How many people
- 200 participants
- Where
- 10 sitesSwitzerland
- Study dates
- Nov 2011to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICD patients primary and secondary prevention according to guidelines
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Switzerland10 sites
University Hospital - Basel
Basel, Canton of Basel-City, 4031
HFR - Hôpital Cantonal - Fribourg
Fribourg, Canton of Fribourg, 1708
HUG - University Hospital Geneva
Geneva, Canton of Geneva, 1211
CHUV, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
CardioCentro Ticino - Lugano
Lugano, Canton Ticino, 6900
Kantonsspital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007
GZO Spital - Wetzikon
Wetzikon, Canton of Zurich, 8620
Klinik Im Park - Zurich
Zurich, Canton of Zurich, 8038
Stadtspital TRIEMLI - Zurich
Zurich, Canton of Zurich, 8063
USZ - University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: 4P Study: A Prospective Study on Predictive Quality Preferring PainFree Therapies
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.
Read the 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.
- Conditions
- Cardiac Arrhythmias
- Keywords
- ICD, ATP therapy, Rescue Shock therapy
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful and non successful therapies
First assessment and analysis of therapy efficacy and appropriate detection and classification
Measured: 24 months follow up
Secondary outcomes (2)
Number of device diagnostics alerts and device integrity alerts
First assessment of alerts and classification
Measured: 24 months follow up
All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE)
Measured: 24 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Martin Fromer, Professor, Principal investigator, CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, SwitzerlandMayella Favre, Study director, Medtronic (Suisse) SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509378
- Sponsor's protocol ID
- CH KEK-ZH-Nr. 2011-0001/4
- Other IDs
- KEK-ZH Nr 2011/0001/4
- Acronym
- 4P
- Status last verified
- Jun 2016
- First submitted
- 10 Jan 2012
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4P Study: A Prospective Study on Predictive Quality Preferring PainFree Therapies
- ClinicalTrials.gov ID
- NCT01509378
- Acronym / sponsor ID
- 4P / CH KEK-ZH-Nr. 2011-0001/4
- Conditions
- Cardiac Arrhythmias
- Keywords
- ICD, ATP therapy, Rescue Shock therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Nov 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICD patients primary and secondary prevention according to guidelines
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Number of device diagnostics alerts and device integrity alerts
Time frame: 24 months follow up
All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE)
Time frame: 24 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Fromer, Professor principal investigator
CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
Mayella Favre study director
Medtronic (Suisse) SA
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful and non successful therapies (time frame: 24 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.