Cardiac Surgery Clinical Trial
— PRINTOfficial title:
Study of Prognostic Factors in Interventional Rhythmology
NCT number | NCT03099057 |
Other study ID # | |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 7, 2017 |
Est. completion date | March 7, 2027 |
Develop a prospective register assessing the short- and long-term complications of patients undergoing interventional rhythm
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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU Brest | Brest |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
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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