NCT03099057

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,805

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

March 17, 2017

Last Update Submit

February 4, 2025

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • duration of intervention

    Day 1

  • dose of X-radiation used

    Day1

  • volume of used contrast agent

    Day1

  • duration of hospitalization

    3 months

  • need for reoperation

    5 years

  • +2 more secondary outcomes

Interventions

follow-up of patients after interventional rhythm operationOTHER

The follow-up will take place at 3 months postoperatively, then at 1 year and then annually for 5 years.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient that must undergo a gesture of interventional rythmology in the Department of Cardiology of the CHRU of Brest

You may qualify if:

  • 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

You may not qualify if:

  • Minor
  • Patient's refusal
  • Patients under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Brest

Brest, 29200, France

Location

Study Officials

  • Jacques Mansourati, Professor

    University Hospital, Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2017

First Posted

April 4, 2017

Study Start

March 7, 2017

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

February 6, 2025

Record last verified: 2025-02

Locations

FR(1)