Study of Prognostic Factors in Interventional Rhythmology

Terminated

• Conditions: Cardiac Surgery

• Registration Number: NCT03099057
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study Start: 2017-03-07
• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2805

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence of adverse clinical events	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

Name	Time	Method
duration of hospitalization	3 months	the duration of hospitalization will be measured
volume of used contrast agent	Day1	The volume of used contrast agent will be measured
duration of intervention	Day 1	The duration of the operation of interventional rhythmology will be measured
dose of X-radiation used	Day1	the dose of X-radiation used shall be measured
need for reoperation	5 years	the need for reoperation will be assessed
evolution of the echocardiographic parameters	5 years	the evolution of the echocardiographic parameters will be estimated
evolution of the ECG	5 years	The evolution of the ECG will be estimated

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France