Persistent or Long-standing Persistent Atrial FibrillationLALA-LAND-AFNCT04240366
Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
A study testing Experimental intervention in people with Persistent or Long-standing Persistent Atrial Fibrillation, run by University of Luebeck at 3 sites in Germany.
Trial summary
Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent or Long-standing Persistent Atrial Fibrillation
- What is being tested?
- Experimental intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 3 sitesGermany
- Study dates
- 17 Dec 2019to Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained >7 days or >12 months, respectively)
- Age ≥18 and ≤80 years
- Indication for AF ablation as per current guidelines
Who cannot join
- Missing informed consent
- LAA diameter >25mm 10mm distant from circumflex artery assessed by TEE
- Paroxysmal atrial fibrillation
- Long-standing persistent atrial fibrillation with a continuous AF duration of >4 years
- Previous pulmonary vein isolation or MAZE surgery
- Previous led atrial appendage closure or surgical excision
- Left atrial diameter >60 mm at baseline
- Left atrial thrombus at baseline
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
University Hospital Eppendorf, Hamburg, Germany
Hamburg, Free and Hanseatic City of Hamburg, 20251
Andreas Metzner, Prof. Dr., 0049407410 ext. 58320, a.metzner@uke.de
- Recruiting
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, 22763
Christian H. Heeger, Prof. Dr., 004940181881 ext. 1221, c.heeger@asklepios.com
- Recruiting
Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany
Lübeck, Schleswig-Holstein, 23538
Roland Tilz, Prof. Dr., 0049451500 ext. 44511, roland.tilz@uksh.de
Charlotte Eitel, Prof. Dr., 0049451500 ext. 44511, charlotte.eitel@uksh.de
About this study
Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.
Read the detailed description
The intervention in the LALA-LAND-AF trial is the additional LAAI in patients with catheter ablation for persistent AF and will be performed once as index ablation as outlined above. With exception of the index ablation, all patients will be treated according to the current clinical practice guidelines for AF as stated by the European Society of Cardiology (ESC) 11,18 and an expert consensus statement on catheter and surgical ablation1. Patients may be treated with a specific antiarrhythmic drug (AAD) for a maximum of 3 months following the index ablation. No repeat ablation for AF should be performed within the first 3 months. Thereafter, repeat ablations are permitted for recurrent AF irrespective of group allocation. Ablation strategy at repeat ablation includes PV re-isolation if required in both groups and re-isolation of the LAA in the intervention group. In the control group, LAAI may only be performed in case all PV were isolated.
- Being tested
- Control intervention, Experimental intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control interventionProcedure or surgery
Also called Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone
patients treated with balloon-based ablation of AF by PVI
Experimental interventionProcedure or surgery
Also called Experimental: Group 2 Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation
patients treated with balloon-based ablation of AF by PVI
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone Receives: Procedure: Control intervention |
| Group 2 | Experimental | Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation Receives: Procedure: Experimental intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until any documented episode of ATa
Time until any documented episode of atrial tachyarrhythmia (ATa: atrial fibrillation or atrial tachycardia) lasting longer than 30 seconds within 3-12 months after index ablation without antiarrhythmic therapy
Measured: 3 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start17 Dec 2019
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent or Long-standing Persistent Atrial FibrillationStudies 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
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- IHF GmbH - Institut für Herzinfarktforschung
- Responsible party
- Principal investigator, Roland Richard Tilz, MD, University of Luebeck
- Investigators
- Roland R. Tilz, Prof. Dr., Study director, Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für RhythmologieSorin S. Popescu, MD, Study chair, Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240366
- Sponsor's protocol ID
- 19-323
- Acronym
- LALA-LAND-AF
- Status last verified
- Aug 2024
- First submitted
- 18 Dec 2019
- Last updated
- 29 Aug 2024
- 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 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04240366
- Acronym / sponsor ID
- LALA-LAND-AF / 19-323
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- IHF GmbH - Institut für Herzinfarktforschung
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 27 Jan 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.
Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.
Detailed description
The intervention in the LALA-LAND-AF trial is the additional LAAI in patients with catheter ablation for persistent AF and will be performed once as index ablation as outlined above. With exception of the index ablation, all patients will be treated according to the current clinical practice guidelines for AF as stated by the European Society of Cardiology (ESC) 11,18 and an expert consensus statement on catheter and surgical ablation1. Patients may be treated with a specific antiarrhythmic drug (AAD) for a maximum of 3 months following the index ablation. No repeat ablation for AF should be performed within the first 3 months. Thereafter, repeat ablations are permitted for recurrent AF irrespective of group allocation. Ablation strategy at repeat ablation includes PV re-isolation if required in both groups and re-isolation of the LAA in the intervention group. In the control group, LAAI may only be performed in case all PV were isolated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Procedure: Control interventionBalloon-based ablation of atrial fibrillation by pulmonary vein isolation alone |
| Group 2 | Experimental | Procedure: Experimental interventionBalloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained >7 days or >12 months, respectively)
- Age ≥18 and ≤80 years
- Indication for AF ablation as per current guidelines
Key exclusion criteria (8 listed)
- Missing informed consent
- LAA diameter >25mm 10mm distant from circumflex artery assessed by TEE
- Paroxysmal atrial fibrillation
- Long-standing persistent atrial fibrillation with a continuous AF duration of >4 years
- Previous pulmonary vein isolation or MAZE surgery
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 |
|---|---|---|
| Control interventionAlso: Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alonepatients treated with balloon-based ablation of AF by PVI | Procedure or surgery | Group 1 |
| Experimental interventionAlso: Experimental: Group 2 Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolationpatients treated with balloon-based ablation of AF by PVI | Procedure or surgery | Group 2 |
Primary outcome
Time until any documented episode of ATa
Time frame: 3 - 12 months
Time until any documented episode of atrial tachyarrhythmia (ATa: atrial fibrillation or atrial tachycardia) lasting longer than 30 seconds within 3-12 months after index ablation without antiarrhythmic therapy
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 29 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Persistent or Long-standing Persistent Atrial Fibrillation
Recruiting
Multitarget Pulse Field Ablation Guided by Endocardial and Non-invasive Atrial Driver Mapping (PFA+ADM) Pilot Study. Development of an Ablation Strategy to Improve the Efficacy of Long Standing Atrial Fibrillation Ablation in Patients With High Comorbidity Burden or Heart Failure
Persistent Atrial Fibrillation Longstanding
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.
Roland R. Tilz, Prof. Dr. study director
Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
Sorin S. Popescu, MD study chair
Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental intervention in people with Persistent or Long-standing Persistent Atrial Fibrillation, run by University of Luebeck at 3 sites in Germany.
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 3 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 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 Roland Tilz, Prof. Dr. (+49451500 ext. 44672, roland.tilz@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until any documented episode of ATa (time frame: 3 - 12 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 29 Aug 2024.