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Study of Prognostic Factors in Interventional Rhythmology (PRINT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099057
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Develop a prospective register assessing the short- and long-term complications of patients undergoing interventional rhythm

Condition or disease Intervention/treatment
Cardiac Surgery Other: follow-up of patients after interventional rhythm operation

Detailed Description:
To assess the fate of patients who have undergone a technical procedure at the Cardiology Plate (implantation / extraction of a pacemaker, a defibrillator, radiofrequency ablation or cryo-ablation, left auricle closure, electro- Physiological exploration), and to determine prognostic factors / markers in this population.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Prognostic Factors in Interventional Rhythmology
Actual Study Start Date : March 7, 2017
Estimated Primary Completion Date : March 7, 2027
Estimated Study Completion Date : March 7, 2027

Intervention Details:
  • Other: follow-up of patients after interventional rhythm operation
    The follow-up will take place at 3 months postoperatively, then at 1 year and then annually for 5 years.


Primary Outcome Measures :
  1. The occurrence of adverse clinical events [ Time Frame: 5 years ]
    The occurrence of the following adverse clinical events: infectious, rhythmic complications, hemodynamic, mortality any causes and cardiovascular post--interventional and in the length-course


Secondary Outcome Measures :
  1. duration of intervention [ Time Frame: Day 1 ]
    The duration of the operation of interventional rhythmology will be measured

  2. dose of X-radiation used [ Time Frame: Day1 ]
    the dose of X-radiation used shall be measured

  3. volume of used contrast agent [ Time Frame: Day1 ]
    The volume of used contrast agent will be measured

  4. duration of hospitalization [ Time Frame: 3 months ]
    the duration of hospitalization will be measured

  5. need for reoperation [ Time Frame: 5 years ]
    the need for reoperation will be assessed

  6. evolution of the ECG [ Time Frame: 5 years ]
    The evolution of the ECG will be estimated

  7. evolution of the echocardiographic parameters [ Time Frame: 5 years ]
    the evolution of the echocardiographic parameters will be estimated



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient that must undergo a gesture of interventional rythmology in the Department of Cardiology of the CHRU of Brest
Criteria

Inclusion Criteria:

Patient to undergo:

  • Implantation of a cardiac pacemaker or cardiac defibrillator or
  • Extraction of pacemaker / defibrillator housing or probes or
  • Realization of a radiofrequency / cryo-ablation:
  • Atrial fibrillation
  • Focus of ventricular tachycardia
  • An accessory or
  • Any electrophysiological exploration or
  • Installation of Holter implantable or
  • Left auricular closure percutaneously Having formulated its non-opposition

Exclusion Criteria:

  • Minor
  • Patient's refusal
  • Patients under legal protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099057


Contacts
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Contact: Jacques Mansourati, Professor jacques.mansourati@chu-brest.fr

Locations
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France
CHRU Brest Recruiting
Brest, France, 29200
Contact: Jacques Mansourati, Professor       jacques.mansourati@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Jacques Mansourati, Professor University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03099057    
Other Study ID Numbers: PRINT
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No