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4P Study: Predictive Quality With Painfree Therapies

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01509378
First received: January 10, 2012
Last updated: April 3, 2014
Last verified: April 2014
  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 Preferring 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: 24 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: 24 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: 24 months follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 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.

  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
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 ClinicalTrials.gov identifier: NCT01509378

Locations
Switzerland
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
Medtronic
Investigators
Principal Investigator: Martin Fromer, Professor CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
Study Director: Raymond 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 3, 2014
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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014