Cardiac Resynchronization TherapyANIMATIONNCT04347109
cArdiac Non Invasive MApping in resynchronizaTION
An observational study of Cardiac Resynchronization Therapy, run by University Hospital, Tours at 1 site in France.
Trial summary
Non-invasive mapping using the Cardio Insight system is performed in heart failure patients requiring biventricular pacing to optimize therapy, and understand mechanisms underlying pacing-induced cardiomyopathy and ventricular arrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization Therapy
- What is being tested?
- Non invasive epicardial mapping
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to 31 Dec 2025
- How long will I take part?
- 6 Months
- 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: Adult patients referred for change or upgrading of a right ventricular pacing device in our center (CHU Tours).
Who may be able to join
- Patients implanted with a biventricular pacing device (CRT) device
- Patients chronically implanted with a right ventricular pacing device.
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: cArdiac Non Invasive MApping in resynchronizaTION Registry
Non-invasive mapping using the Cardio Insight system is performed in heart failure patients requiring biventricular pacing to optimize therapy, and understand mechanisms underlying pacing-induced cardiomyopathy and ventricular arrhythmias.
Read the detailed description
Non-invasive mapping using the Cardio Insight system is prospectively performed routinely in heart failure patients requiring cardiac resynchronization therapy.
Control patients are included, requiring chronic permanent right ventricular pacing.
Specific focus include: optimization of programming parameters, pacing-induced cardiomyopathy, ventricular arrhythmias, defibrillation threshold testing and electrical shocks.
- Conditions
- Cardiac Resynchronization Therapy
- Being tested
- Non invasive epicardial mapping
- Keywords
- non invasive mapping, cardiac resynchronization therapy, pacing-induced cardiomyopathy, electrical shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive epicardial mappingDiagnostic test
Also called Cardio Insight system, ECG imaging
Non invasive mapping using Cardio Insight system is performed in all included patients.
| Study group | Role | What they receive |
|---|---|---|
| Biventricular Pacing | Patients implanted with a device enabling cardiac resynchronization therapy. Receives: Diagnostic Test: Non invasive epicardial mapping | |
| Right Ventricular Pacing | Patients implanted with a right ventricular pacing device. Receives: Diagnostic Test: Non invasive epicardial mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular activation map
Differences (qualitative and quantitative measurements) in ventricular activation patterns are identified.
Measured: Up to 6 months
Response to CRT
Composite endpoint : volumetric response, heart failure hospitalizations, and all-cause mortality.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Sep 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Organization not finalized
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Resynchronization TherapyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent Fauchier, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347109
- Sponsor's protocol ID
- ANIMATION Registry
- Acronym
- ANIMATION
- Status last verified
- May 2024
- First submitted
- 8 Apr 2020
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- cArdiac Non Invasive MApping in resynchronizaTION Registry
- ClinicalTrials.gov ID
- NCT04347109
- Acronym / sponsor ID
- ANIMATION / ANIMATION Registry
- Conditions
- Cardiac Resynchronization Therapy
- Keywords
- non invasive mapping, cardiac resynchronization therapy, pacing-induced cardiomyopathy, electrical shock
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Organization not finalized
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Apr 2020 (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.
Non-invasive mapping using the Cardio Insight system is performed in heart failure patients requiring biventricular pacing to optimize therapy, and understand mechanisms underlying pacing-induced cardiomyopathy and ventricular arrhythmias.
Detailed description
Non-invasive mapping using the Cardio Insight system is prospectively performed routinely in heart failure patients requiring cardiac resynchronization therapy.
Control patients are included, requiring chronic permanent right ventricular pacing.
Specific focus include: optimization of programming parameters, pacing-induced cardiomyopathy, ventricular arrhythmias, defibrillation threshold testing and electrical shocks.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biventricular Pacing | – | Diagnostic Test: Non invasive epicardial mappingPatients implanted with a device enabling cardiac resynchronization therapy. |
| Right Ventricular Pacing | – | Diagnostic Test: Non invasive epicardial mappingPatients implanted with a right ventricular pacing device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred for change or upgrading of a right ventricular pacing device in our center (CHU Tours).
Key inclusion criteria (2 listed)
- Patients implanted with a biventricular pacing device (CRT) device
- Patients chronically implanted with a right ventricular pacing device.
Key exclusion criteria (1 listed)
- Age <18 years
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 |
|---|---|---|
| Non invasive epicardial mappingAlso: Cardio Insight system, ECG imagingNon invasive mapping using Cardio Insight system is performed in all included patients. | Diagnostic test | Biventricular Pacing, Right Ventricular Pacing |
Primary outcome
Ventricular activation map
Time frame: Up to 6 months
Differences (qualitative and quantitative measurements) in ventricular activation patterns are identified.
Response to CRT
Time frame: Up to 2 years
Composite endpoint : volumetric response, heart failure hospitalizations, and all-cause mortality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Resynchronization Therapy, run by University Hospital, Tours 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 2 inclusion and 1 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: paused, as of the sponsor's last update on 14 May 2024. 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?
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?
Ventricular activation map (time frame: Up to 6 months). The study lists 2 primary outcomes in all. 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 14 May 2024.