Study of Prognostic Factors in Interventional Rhythmology (PRINT)

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

Study Overview

• Status: Terminated
• Conditions: Cardiac Surgery
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 2805

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • CHRU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of adverse clinical events	The occurrence of the following adverse clinical events: infectious, rhythmic complications, hemodynamic, mortality any causes and cardiovascular post--interventional and in the length-course	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Jacques Mansourati, Professor, University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2017
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 29BRC16.0104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No