Cardiac SurgeryPRINTNCT03099057
Study of Prognostic Factors in Interventional Rhythmology
An observational study of Cardiac Surgery, run by University Hospital, Brest at 1 site in France.
Trial summary
Develop a prospective register assessing the short- and long-term complications of patients undergoing interventional rhythm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- follow-up of patients after interventional rhythm operation
- How many people
- 2,805 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2017to 13 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient that must undergo a gesture of interventional rythmology in the Department of Cardiology of the CHRU of Brest
Who may be able to join
- 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
Show all 10Show fewer
- An accessory or
- Any electrophysiological exploration or
- Installation of Holter implantable or
- Left auricular closure percutaneously Having formulated its non-opposition
Who cannot join
- Minor
- Patient's refusal
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Develop a prospective register assessing the short- and long-term complications of patients undergoing interventional rhythm
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- follow-up of patients after interventional rhythm operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (7)
duration of intervention
The duration of the operation of interventional rhythmology will be measured
Measured: Day 1
dose of X-radiation used
the dose of X-radiation used shall be measured
Measured: Day1
volume of used contrast agent
The volume of used contrast agent will be measured
Measured: Day1
duration of hospitalization
the duration of hospitalization will be measured
Measured: 3 months
need for reoperation
the need for reoperation will be assessed
Measured: 5 years
evolution of the ECG
The evolution of the ECG will be estimated
Measured: 5 years
evolution of the echocardiographic parameters
the evolution of the echocardiographic parameters will be estimated
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start7 Mar 2017
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: Lake of personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,805 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Mansourati, Professor, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099057
- Sponsor's protocol ID
- 29BRC16.0104
- Acronym
- Status last verified
- Feb 2025
- First submitted
- 17 Mar 2017
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prognostic Factors in Interventional Rhythmology
- ClinicalTrials.gov ID
- NCT03099057
- Acronym / sponsor ID
- PRINT / 29BRC16.0104
- Conditions
- Cardiac Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lake of personnel
- Enrolment
- 2,805 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient that must undergo a gesture of interventional rythmology in the Department of Cardiology of the CHRU of Brest
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Minor
- Patient's refusal
- Patients under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow-up of patients after interventional rhythm operationThe follow-up will take place at 3 months postoperatively, then at 1 year and then annually for 5 years. | Other | – |
Primary outcome
The occurrence of adverse clinical events
Time frame: 5 years
The occurrence of the following adverse clinical events: infectious, rhythmic complications, hemodynamic, mortality any causes and cardiovascular post--interventional and in the length-course
7 secondary outcomes
duration of intervention
Time frame: Day 1
dose of X-radiation used
Time frame: Day1
volume of used contrast agent
Time frame: Day1
duration of hospitalization
Time frame: 3 months
need for reoperation
Time frame: 5 years
evolution of the ECG
Time frame: 5 years
evolution of the echocardiographic parameters
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Lake of personnel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Mansourati, Professor principal investigator
University Hospital, Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lake of personnel). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of adverse clinical events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.