Cardiac AnomalyCRT3DNCT05429645
Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation
A study testing setting up of the pace maker in people with Cardiac Anomaly, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Anomaly
- What is being tested?
- setting up of the pace maker
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2022to 23 Jan 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patient with indication for implantation of a classic multisite pacemaker;
- New York Heart Association II/IV patient despite optimal medical treatment;
- Patient with left ventricular ejection fraction ≤35%;
- Patient with a widened QRS > 120ms;
- Patient with at least one lateral coronary sinus vein visualized on angiography during the 1st procedure (if performed);
- Patient with failure of resynchronization via the endovenous route due to difficulty in accessing the coronary sinus or instability in the coronary sinus;
- Patient having been informed and having signed an informed consent form;
- Patient able to understand the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), and to complete questionnaires.
Who cannot join
- Patient with resynchronization failure due to occlusion of the superior vena cava;
- Patient with no usable lateral coronary sinus vein;
- Patient with a life expectancy < 3 months;
- Patient wearing a vena cava filter;
- Patient with active sepsis;
- Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient not benefiting from a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation: CRT3D Study
The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium
Read the detailed description
As part of this study, to avoid surgery, the doctor will use a 3-dimensional (3D) guidance technique to position the heart probes in an optimal position during a new endovascular intervention.
- Conditions
- Cardiac Anomaly
- Being tested
- setting up of the pace maker
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
setting up of the pace makerProcedure or surgery
Setting up of a pace maker using a 3-dimensional (3D) guidance technique
| Study group | Role | What they receive |
|---|---|---|
| 3-dimensional guidance technique | Experimental | 3-dimensional (3D) guidance technique to position the heart probes in the setting up of a pace maker Receives: Procedure: setting up of the pace maker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Setting up with success of the Left Ventricular lead
Feasibility of cardiac resynchronization under 3 dimension assistance in the event of primary implantation failure will be assessed by the proportion of patients for whom the Left Ventricular lead has been placed successfully with a pacemaker
Measured: during the time of the setting up of the pace maker
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start28 Jul 2022
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Why it stopped: A new technique has rendered the study technique obsolete, making it inappropriate to continue the study due to lack of therapeutic interest.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AnomalyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429645
- Sponsor's protocol ID
- 2022-A00811-42
- Acronym
- CRT3D
- Status last verified
- Mar 2025
- First submitted
- 17 Jun 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation: CRT3D Study
- ClinicalTrials.gov ID
- NCT05429645
- Acronym / sponsor ID
- CRT3D / 2022-A00811-42
- Conditions
- Cardiac Anomaly
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A new technique has rendered the study technique obsolete, making it inappropriate to continue the study due to lack of therapeutic interest.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 23 Jun 2022 (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.
The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium
Detailed description
As part of this study, to avoid surgery, the doctor will use a 3-dimensional (3D) guidance technique to position the heart probes in an optimal position during a new endovascular intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3-dimensional guidance technique | Experimental | Procedure: setting up of the pace maker3-dimensional (3D) guidance technique to position the heart probes in the setting up of a pace maker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with indication for implantation of a classic multisite pacemaker;
- New York Heart Association II/IV patient despite optimal medical treatment;
- Patient with left ventricular ejection fraction ≤35%;
- Patient with a widened QRS > 120ms;
- Patient with at least one lateral coronary sinus vein visualized on angiography during the 1st procedure (if performed);
Key exclusion criteria (8 listed)
- Patient with resynchronization failure due to occlusion of the superior vena cava;
- Patient with no usable lateral coronary sinus vein;
- Patient with a life expectancy < 3 months;
- Patient wearing a vena cava filter;
- Patient with active sepsis;
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 |
|---|---|---|
| setting up of the pace makerSetting up of a pace maker using a 3-dimensional (3D) guidance technique | Procedure or surgery | 3-dimensional guidance technique |
Primary outcome
Setting up with success of the Left Ventricular lead
Time frame: during the time of the setting up of the pace maker
Feasibility of cardiac resynchronization under 3 dimension assistance in the event of primary implantation failure will be assessed by the proportion of patients for whom the Left Ventricular lead has been placed successfully with a pacemaker
Results and safety
The study was stopped early (reason given: A new technique has rendered the study technique obsolete, making it inappropriate to continue the study due to lack of therapeutic interest.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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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?
A study testing setting up of the pace maker in people with Cardiac Anomaly, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 8 inclusion and 8 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 30 Mar 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: A new technique has rendered the study technique obsolete, making it inappropriate to continue the study due to lack of therapeutic interest.). 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?
Setting up with success of the Left Ventricular lead (time frame: during the time of the setting up of the pace maker). 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 30 Mar 2025.