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Clinical Trials/NCT03099057
NCT03099057
Terminated
Not Applicable

Study of Prognostic Factors in Interventional Rhythmology

University Hospital, Brest1 site in 1 country2,805 target enrollmentMarch 7, 2017
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ConditionsCardiac Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
University Hospital, Brest
Enrollment
2805
Locations
1
Primary Endpoint
The occurrence of adverse clinical events
Status
Terminated
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2017
End Date
March 13, 2020
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

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

Outcomes

Primary Outcomes

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 Outcomes

  • duration of hospitalization(3 months)
  • volume of used contrast agent(Day1)
  • duration of intervention(Day 1)
  • dose of X-radiation used(Day1)
  • need for reoperation(5 years)
  • evolution of the echocardiographic parameters(5 years)
  • evolution of the ECG(5 years)

Study Sites (1)

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