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Study of Prognostic Factors in Interventional Rhythmology

Study of Prognostic Factors in Interventional Rhythmology

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03099057
Acronym
PRINT
Enrollment
2805
Registered
2017-04-04
Start date
2017-03-07
Completion date
2020-03-13
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

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.

Interventions

OTHERfollow-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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The occurrence of adverse clinical events5 yearsThe occurrence of the following adverse clinical events: infectious, rhythmic complications, hemodynamic, mortality any causes and cardiovascular post--interventional and in the length-course

Secondary

MeasureTime frameDescription
dose of X-radiation usedDay1the dose of X-radiation used shall be measured
volume of used contrast agentDay1The volume of used contrast agent will be measured
duration of hospitalization3 monthsthe duration of hospitalization will be measured
duration of interventionDay 1The duration of the operation of interventional rhythmology will be measured
evolution of the ECG5 yearsThe evolution of the ECG will be estimated
evolution of the echocardiographic parameters5 yearsthe evolution of the echocardiographic parameters will be estimated
need for reoperation5 yearsthe need for reoperation will be assessed

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026