4P Study: Predictive Quality With Painfree Therapies
This study is currently recruiting participants.
Verified April 2013 by Medtronic Bakken Research Center
Sponsor:
Medtronic Bakken Research Center
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01509378
First received: January 10, 2012
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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 |
|---|
|
Cardiac Arrhythmias |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 4P Study: A Prospective Study on Predictive Quality Preferencing PainFree Therapies |
Resource links provided by NLM:
Further study details as provided by Medtronic Bakken Research Center:
Primary Outcome Measures:
- Number of successful and non successful therapies [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ]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: 12 months follow up ] [ Designated as safety issue: No ]First assessment of alerts and classification
- All causes hospitalizations, cardiovascular hospitalizations, death, severe adverse events (SAE) [ Time Frame: 12 months follow up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
ICD patients primary and secondary prevention according to guidelines
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509378
Locations
| Switzerland | |
| University Hospital - Basel | Recruiting |
| Basel, BS, Switzerland, 4031 | |
| Contact: Beat Schaer, Dr.med. beat.schaer@usb.ch | |
| Principal Investigator: Beat Schaer, Dr.med. | |
| HFR - Hôpital Cantonal - Fribourg | Recruiting |
| Fribourg, FR, Switzerland, 1708 | |
| Contact: Denis Graf, Dr.med. denis.graf@h-fr.ch | |
| Principal Investigator: Denis Graf, Dr.med. | |
| HUG - University Hospital Geneva | Recruiting |
| Geneva, GE, Switzerland, 1211 | |
| Contact: Henri Sunthorn, Dr.med. henri.sunthorn@hug.ch | |
| Principal Investigator: Henri Sunthorn, Dr.med. | |
| Kantonspital St.Gallen | Recruiting |
| St.Gallen, SG, Switzerland, 9007 | |
| Contact: Peter Ammann, Prof peter.ammann@kssg.ch | |
| Sub-Investigator: Franziska Rohner, Dr.med. | |
| Sub-Investigator: David Altmann, Dr.med. | |
| Principal Investigator: Peter Ammann, Prof | |
| CardioCentro Ticino - Lugano | Recruiting |
| Lugano, TI, Switzerland, 6900 | |
| Contact: Tiziano Moccetti, Prof tiziano.moccetti@cardiocentro.org | |
| Sub-Investigator: Angelo Auricchio, Prof | |
| Sub-Investigator: Francois Regoli, Dr.med. | |
| Sub-Investigator: Marta Acena Ramos, Dr.med. | |
| Principal Investigator: Tiziano Moccetti, Prof | |
| CHUV, Centre Hospitalier Universitaire Vaudois | Recruiting |
| Lausanne, VD, Switzerland, 1011 | |
| Contact: Martin Fromer, Professor +41 21 314 11 11 martin.fromer@chuv.ch | |
| Principal Investigator: Martin Fromer, Professor | |
| Sub-Investigator: Denis Graf, Dr.med | |
| GZO Spital - Wetzikon | Recruiting |
| Wetzikon, ZH, Switzerland, 8620 | |
| Contact: Urs Eriksson, Prof urs.eriksson@gzo.ch | |
| Sub-Investigator: Nazmi Krasniqi, Dr.med. | |
| Principal Investigator: Urs Eriksson, Prof | |
| USZ - University Hospital Zurich | Recruiting |
| Zurich, ZH, Switzerland, 8091 | |
| Contact: Firat Duru, Prof firat.duru@usz.ch | |
| Principal Investigator: Firat Duru, Prof | |
| Sub-Investigator: David Hurlimann, Dr.med. | |
| Stadtspital TRIEMLI - Zurich | Recruiting |
| Zurich, ZH, Switzerland, 8063 | |
| Contact: Rainer Zbinden, Dr.med. rainer.zbinden@triemli.zurich.ch | |
| Sub-Investigator: Andreas Mueller, Dr.med. | |
| Principal Investigator: Rainer Zbinden, Dr.med. | |
| Klinik Im Park - Zurich | Recruiting |
| Zurich, ZH, Switzerland, 8038 | |
| Contact: Barbara Naegeli, Prof barbara.naegeli@hirslanden.ch | |
| Principal Investigator: Barbara Naegeli, Prof | |
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
| Principal Investigator: | Martin Fromer, Professor | CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland |
| Study Director: | Ray Moser, Ph.D | Medtronic (Suisse) SA |
More Information
No publications provided
| Responsible Party: | Medtronic Bakken Research Center |
| ClinicalTrials.gov Identifier: | NCT01509378 History of Changes |
| Other Study ID Numbers: | CH KEK-ZH-Nr. 2011-0001/4, KEK-ZH Nr 2011/0001/4 |
| Study First Received: | January 10, 2012 |
| Last Updated: | April 29, 2013 |
| Health Authority: | Switzerland: Ethikkommission Switzerland: Federal Office of Public Health Switzerland: Laws and standards Switzerland: Swissmedic |
Keywords provided by Medtronic Bakken Research Center:
|
ICD ATP therapy Rescue Shock therapy |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013