Arrhythmias, CardiacFLUTMALINENCT05063032
Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation.
A study testing Radiofrecuency ablation in people with Arrhythmias, Cardiac, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Unicenter, 1:1 randomized, open-labelled clinical trial comparing left atrial flutter ablation using high density mapping or strict lineal ablation. Main outcome: arrhythmia recurrences over 1 year follow-up with daily 1-lead 30 seconds ECG samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- Radiofrecuency ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jan 2022to 1 Oct 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
- Left atrial flutter1 inducible during electrophysiological evaluation.
- Clinical indication for ablation: a) symptoms (palpitations, dizziness, syncope, breathlessness, derangement, heart failure), tachymiopathy, b) poor heart rate control, or c) recurrence after electrical cardioversion or failure of one antiarrhythmic drug.
- Informed consent.
- Patients will be enrolled if LAFL is clinically suspected but finally randomized if this mechanism is established by electrophysiologic evaluation according to the criteria stated above.
Who cannot join
- Previous ablation of LAFL.
- Previous linear ablation in the LA except for pulmonary vein isolation.
- Absolute contraindication for oral anticoagulation.
- Stroke or acute coronary syndrome less than 3 months before ablation.
- Complex congenital heart disease.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
La Paz University Hospital, Department of Cardiology
Madrid
José Luis Merino, MD, +34 912071301, lapaz@arritmias.net
About this study
Official title: Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation - the FLUTMALINE Trial
Unicenter, 1:1 randomized, open-labelled clinical trial comparing left atrial flutter ablation using high density mapping or strict lineal ablation. Main outcome: arrhythmia recurrences over 1 year follow-up with daily 1-lead 30 seconds ECG samples.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- Radiofrecuency ablation
- Keywords
- Left atrial flutter, Linear ablation, High-density mapping
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrecuency ablationOther
Radiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation.
| Study group | Role | What they receive |
|---|---|---|
| High-density mapping guided ablation | Experimental | High-density map and return-cycles map in order to localize the protected isthmus with precision for focal/minimal ablation. Receives: Other: Radiofrecuency ablation |
| Empirical linear ablation | Active comparator | Empirical predefined set of linear ablation. Receives: Other: Radiofrecuency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.
Daily 1-lead 30 seconds ECG samples.
Measured: 1 year follow-up
Secondary outcomes (6)
Acute success.
Termination of all organized atrial arrhythmias (spontaneous or induced, organized and stable atrial arrhythmias with duration ≥3 min).
Measured: Acute intraprocedural.
Non-inducibility.
Non-inducibility of all organized atrial arrhythmias at the end of the ablation procedure.
Measured: Acute intraprocedural.
Procedure duration.
From vein puncture up to seaths withdrawal.
Measured: Acute intraprocedural.
Left atrial dwell time.
From transeptal puncture up to catheters withdrawal from the left atrium.
Measured: Acute intraprocedural.
Safety.
Incidence of compications: 1)vascular lesions, 2)cardiac tamponade, 3)embolism.
Measured: Acute a 1 month after ablation (procedure-related complications).
Hospitalization.
Number of hospitalizations due to atrial arrhythmia episodes at 1-year follow-up.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start28 Jan 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 parallell, randomized, controlled, open-label, single center clinical trial.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sergio Castrejón-Castrejón, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063032
- Sponsor's protocol ID
- 5825 v 3.0, 3030th March 2021
- Acronym
- FLUTMALINE
- Status last verified
- Jan 2024
- First submitted
- 7 Sep 2021
- Last updated
- 10 Jan 2024
- 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation - the FLUTMALINE Trial
- ClinicalTrials.gov ID
- NCT05063032
- Acronym / sponsor ID
- FLUTMALINE / 5825 v 3.0, 3030th March 2021
- Conditions
- Arrhythmias, Cardiac
- Keywords
- Left atrial flutter, Linear ablation, High-density mapping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 30 Sep 2021 (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.
Unicenter, 1:1 randomized, open-labelled clinical trial comparing left atrial flutter ablation using high density mapping or strict lineal ablation. Main outcome: arrhythmia recurrences over 1 year follow-up with daily 1-lead 30 seconds ECG samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 parallell, randomized, controlled, open-label, single center clinical trial.
| Arm | Type | Receives |
|---|---|---|
| High-density mapping guided ablation | Experimental | Other: Radiofrecuency ablationHigh-density map and return-cycles map in order to localize the protected isthmus with precision for focal/minimal ablation. |
| Empirical linear ablation | Active comparator | Other: Radiofrecuency ablationEmpirical predefined set of linear ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Left atrial flutter1 inducible during electrophysiological evaluation.
- Clinical indication for ablation: a) symptoms (palpitations, dizziness, syncope, breathlessness, derangement, heart failure), tachymiopathy, b) poor heart rate control, or c) recurrence after electrical cardioversion or failure of one antiarrhythmic drug.
- Informed consent.
Key exclusion criteria (5 listed)
- Previous ablation of LAFL.
- Previous linear ablation in the LA except for pulmonary vein isolation.
- Absolute contraindication for oral anticoagulation.
- Stroke or acute coronary syndrome less than 3 months before ablation.
- Complex congenital heart disease.
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 |
|---|---|---|
| Radiofrecuency ablationRadiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation. | Other | Empirical linear ablation, High-density mapping guided ablation |
Primary outcome
Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.
Time frame: 1 year follow-up
Daily 1-lead 30 seconds ECG samples.
6 secondary outcomes
Acute success.
Time frame: Acute intraprocedural.
Non-inducibility.
Time frame: Acute intraprocedural.
Procedure duration.
Time frame: Acute intraprocedural.
Left atrial dwell time.
Time frame: Acute intraprocedural.
Safety.
Time frame: Acute a 1 month after ablation (procedure-related complications).
Hospitalization.
Time frame: 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrecuency ablation in people with Arrhythmias, Cardiac, run by Hospital Universitario La Paz at 1 site in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Jan 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 Spain. 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?
Contact Sergio C Castrejón, PhD (+34 659048245, lapaz@arritmias.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group. (time frame: 1 year follow-up). 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 10 Jan 2024.