Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 10, 2012
April 3, 2014
November 2011
January 2016   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01509378 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
4P Study: Predictive Quality With Painfree Therapies
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

ICD patients primary and secondary prevention according to guidelines

Cardiac Arrhythmias
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
March 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01509378
CH KEK-ZH-Nr. 2011-0001/4, KEK-ZH Nr 2011/0001/4
Yes
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Medtronic
Principal Investigator: Martin Fromer, Professor CHUV, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
Study Director: Raymond Moser, Ph.D Medtronic (Suisse) SA
Medtronic Bakken Research Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP