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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03099057
Other study ID # PRINT
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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