Study of Prognostic Factors in Interventional Rhythmology

Cardiac Surgery Clinical Trial

— PRINT  

Official title:

Study of Prognostic Factors in Interventional Rhythmology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03099057
• Other study ID #: PRINT
• Status: Recruiting
• Start date: March 7, 2017
• Est. completion date: March 7, 2027

Study information

• Verified date: October 2018
• Source: University Hospital, Brest
• Contact: Jacques Mansourati, Professor
• Email: jacques.mansourati[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 7, 2027
• Est. primary completion date: March 7, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

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