Mitral Annular DisjunctionILR MAD IITNCT07436962
Loop Recorder Implantation in Patients With Mitral Annular Disjunction
A study testing loop recorder implantation in people with Mitral Annular Disjunction and Mitral Valve, run by Gottsegen National Cardiovascular Institute at 1 site in Hungary.
Trial summary
The goal of clinical trial is to prospectively collect data to investigate the prevalence of arrhythmia in young patients diagnosed with mitral annular disjunction who have no indication for implantable cardioverter defibrillator (ICD) or implantable loop recorder (ILR) implantation according to the current guideline. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mitral Annular Disjunction, Mitral Valve, Arrhythmia Ventricular
- What is being tested?
- loop recorder implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- 5 Dec 2025to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 60 years
- patient not incapacitated
- mitral annular disjunction confirmed by echocardiography
- MR scan confirmed late-type gadolinium enhancement in the myocardium
Who cannot join
- lack of informed consent
- age under 18 years
- limited capability
- guardianship
- active infection
- cancer
- previous ICD implantation
- indication for ICD or ILR implantation based on current recommendation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Gottsegen National Cardiovascular Institute
Budapest, 1096
Attila Kardos, MD PhD, +36703388864, attila.kardos@gokvi.hu
About this study
The goal of clinical trial is to prospectively collect data to investigate the prevalence of arrhythmia in young patients diagnosed with mitral annular disjunction who have no indication for implantable cardioverter defibrillator (ICD) or implantable loop recorder (ILR) implantation according to the current guideline. The study population is young (age 18-60), the participating patients have mitral annular disjunction confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium. This patient population has an increased risk of ventricular arrhythmias and sudden cardiac death. The investigators plan to implant 20 BioMonitor IIIm ILRs over a year in patients with mild or uncertain symptoms (dizziness, palpitations) and no malignant arrhythmias.
Aims of the study:
Read more
- Screening of asymptomatic patients with MAD for arrhythmia.
- In case of symptoms, to prove or exclude the underlying arrhythmia.
BioMonitor IIIm ILR implantation is planned in the following patient population:
- Inclusion of 20 patients with mitral annular disjunction confirmed by echocardiography and late gadolinium enhancement in the myocardium by MRI.
- Only patients who do not meet the current indication for ICD or ILR implantation based on the current recommendation will be included in the study.
- Conditions
- Mitral Annular Disjunction, Mitral Valve, Arrhythmia Ventricular, Sudden Cardiac Death Due to Cardiac Arrhythmia, Loop Recorder
- Being tested
- loop recorder implantation
- Keywords
- mitral annular disjunction, MAD, sudden cardiac death, loop recorder, ventricular arrhythmia, mitral valve
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loop recorder implantationDevice
Also called ILR implantation
During the operation, a small incision is made in the chest with local anesthesia and the implantation is performed in a pacemaker operating room, following the rules of sepsis/antisepsis. The surgical suture is used to close the wound. The healing time is about 10 days, during which time a covering bandage is needed. During the operation we use absorbable sutures, no suture removal is necessary. After implantation, the patient's lifestyle is not restricted. Avoidance of strong magnetic fields, which may result in noise recording, is necessary. The procedure is performed as an outpatient surgery and patients are discharged to their homes on the day of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| MAD-ILR | Experimental | Patients with mitral annular disjunction, confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium, undergoing loop recorder implantation. Receives: Device: loop recorder implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular arrhythmia screened with loop recorder
Periprocedurally, at 6-, 12-, 18- and 24-month follow-up, we perform control examinations (e.g. 12-lead ECG, echocardiography, ILR interrogation). Arrhythmias recorded by ILR are documented and analyzed. Our results may contribute to a better understanding of the indications for ILR and ICD implantation in patients with MAD, thereby helping to reduce the risk of sudden cardiac death.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Dec 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Annular DisjunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gottsegen National Cardiovascular Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor
- Investigators
- Attila Kardos, MD PhD, Principal investigator, Gottsegen National Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436962
- Sponsor's protocol ID
- 1034
- Other IDs
- FF110
- Acronym
- ILR MAD IIT
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loop Recorder Implantation in Patients With Mitral Annular Disjunction
- ClinicalTrials.gov ID
- NCT07436962
- Acronym / sponsor ID
- ILR MAD IIT / 1034
- Conditions
- Mitral Annular Disjunction, Mitral Valve, Arrhythmia Ventricular, Sudden Cardiac Death Due to Cardiac Arrhythmia, Loop Recorder
- Keywords
- mitral annular disjunction, MAD, sudden cardiac death, loop recorder, ventricular arrhythmia, mitral valve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gottsegen National Cardiovascular InstituteUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 27 Feb 2026 (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 goal of clinical trial is to prospectively collect data to investigate the prevalence of arrhythmia in young patients diagnosed with mitral annular disjunction who have no indication for implantable cardioverter defibrillator (ICD) or implantable loop recorder (ILR) implantation according to the current guideline. The study population is young (age 18-60), the participating patients have mitral annular disjunction confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium. This patient population has an increased risk of ventricular arrhythmias and sudden cardiac death. The investigators plan to implant 20 BioMonitor IIIm ILRs over a year in patients with mild or uncertain symptoms (dizziness, palpitations) and no malignant arrhythmias.
Aims of the study:
- Screening of asymptomatic patients with MAD for arrhythmia.
- In case of symptoms, to prove or exclude the underlying arrhythmia.
BioMonitor IIIm ILR implantation is planned in the following patient population:
- Inclusion of 20 patients with mitral annular disjunction confirmed by echocardiography and late gadolinium enhancement in the myocardium by MRI.
- Only patients who do not meet the current indication for ICD or ILR implantation based on the current recommendation will be included in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAD-ILR | Experimental | Device: loop recorder implantationPatients with mitral annular disjunction, confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium, undergoing loop recorder implantation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 18 and 60 years
- patient not incapacitated
- mitral annular disjunction confirmed by echocardiography
- MR scan confirmed late-type gadolinium enhancement in the myocardium
Key exclusion criteria (8 listed)
- lack of informed consent
- age under 18 years
- limited capability
- guardianship
- active infection
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 |
|---|---|---|
| loop recorder implantationAlso: ILR implantationDuring the operation, a small incision is made in the chest with local anesthesia and the implantation is performed in a pacemaker operating room, following the rules of sepsis/antisepsis. The surgical suture is used to close the wound. The healing time is about 10 days, during which time a covering bandage is needed. During the operation we use absorbable sutures, no suture removal is necessary. After implantation, the patient's lifestyle is not restricted. Avoidance of strong magnetic fields, which may result in noise recording, is necessary. The procedure is performed as an outpatient surgery and patients are discharged to their homes on the day of the procedure. | Device | MAD-ILR |
Primary outcome
Ventricular arrhythmia screened with loop recorder
Time frame: 24 months
Periprocedurally, at 6-, 12-, 18- and 24-month follow-up, we perform control examinations (e.g. 12-lead ECG, echocardiography, ILR interrogation). Arrhythmias recorded by ILR are documented and analyzed. Our results may contribute to a better understanding of the indications for ILR and ICD implantation in patients with MAD, thereby helping to reduce the risk of sudden cardiac death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Mitral Annular Disjunction
Active, not recruitingPhase 3
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
Active, not recruiting
Prospective Multicenter Study on Mitral Annular Disjunction
Mitral Valve Disease
Not yet recruitingObservational study
A Study of Mitral Annular Disjunction in Mitral Valve Prolapse Patients and Arrhythmia Risk
Mitral Valve Prolapse, Mitral Valve Insufficiency
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.
Attila Kardos, MD PhD principal investigator
Gottsegen National Cardiovascular Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing loop recorder implantation in people with Mitral Annular Disjunction and Mitral Valve, run by Gottsegen National Cardiovascular Institute at 1 site in Hungary.
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 4 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. 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 Hungary. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Attila Kardos, MD PhD (+36703388864, attila.kardos@gokvi.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular arrhythmia screened with loop recorder (time frame: 24 months). 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 2 Mar 2026.