Atrial FibrillationASTRO AFNCT04056390
Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences
A study testing Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy in people with Atrial Fibrillation, run by Cardioangiologisches Centrum Bethanien at 7 sites in Germany.
Trial summary
The aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation. The present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory AF despite previous AF ablation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 7 sitesGermany
- Study dates
- 1 Aug 2019to 15 Feb 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines.
- Permanent pulmonary vein isolation according to mapping with a spiral mapping catheter
- Age 18-85 years.
- Left atrial size < 55mm.
- Left ventricular ejection fraction ≥ 45%.
- Patient is able to provide informed consent and is willing to comply with the study protocol.
Who cannot join
- Contraindications for repeat ablation
- Reconnected pulmonary veins according to mapping results with a spiral mapping catheter
- Minimal diameter of LAA neck ≥25mm
- History of mitral valve surgery
- Severe mitral valve regurgitation
- Inability to be treated with oral anticoagulation
Show all 13Show fewer
- Presence of intracardiac thrombi
- Chronic obstructive pulmonary disease treated with long acting bronchodilatators
- Asthma
- Obstructive sleep apnea syndrome
- Pregnancy
- Participation in other clinical studies
- Unwilling to follow the study protocol and to attend follow-up visits
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, 32545
Universitätsklinikum Köln
Cologne, 50937
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, 60431
Universitätsmedizin Greifswald
Greifswald, 17475
Universitäres Herz- und Gefäßzentrum UKE Hamburg
Hamburg, 20246
Universitätsklinikum Schleswig Holstein
Lübeck, 23538
Universitäts Klinikum Ulm
Ulm, 89081
About this study
The aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation.
The present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory AF despite previous AF ablation.
Read more
After PV remapping confirming durable PVI patients will be assigned to 2 different groups: Group A: Substrate modification.
After obtaining a voltage map of the LA, substrate modification will be performed aiming at low-voltage areas (LVA) < 0.5mV.
Group B: LAA isolation. Patients will undergo LAA-isolation using the cryoballoon (CB). Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (CARTO, EnSite) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance).
The primary endpoint is freedom from documented recurrence of AF or any atrial tachyarrhythmia lasting > 30 seconds between day 91 and 365 after the index procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy
- Keywords
- catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation using irrigated radiofrequency current ablation or cryothermal energyProcedure or surgery
Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.
| Study group | Role | What they receive |
|---|---|---|
| Substrate Modification | Active comparator | After obtaining a voltage map of the LA, substrate modification by catheter ablation using an irrigated radio frequency current ablation catheter will be performed aiming at low-voltage areas (LVA) < 0.5mV. Receives: Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy |
| LAA Isolation | Active comparator | Patients will undergo LAA-isolation using the cryoballoon (CB). Six weeks later patients will undergo re-mapping. In case of residual conduction LAA-reisolation will be performed. In case of durable LAA isolation, interventional LAA occlusion is recommended. Receives: Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia Recurrence
Freedom from AF/AT
Measured: Day 91-365 after index ablation
Secondary outcomes (2)
Incidence of periprocedural complications
Incidence of periprocedural complications such as cardiac perforation, thromboembolic events or bleeding
Measured: day 0 - day 365
Number of electrical cardioversions and hospitalizations
Number of electrical cardioversions and hospitalizations
Measured: day0 - day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Aug 2019
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, CRO Kottmann
- Responsible party
- Sponsor
- Investigators
- Boris Schmidt, MD, Principal investigator, Cardioangiologisches Centrum Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056390
- Sponsor's protocol ID
- SF124/2017
- Acronym
- ASTRO AF
- Status last verified
- Nov 2023
- First submitted
- 12 Aug 2019
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmidt B, Bordignon S, Metzner A, Sommer P, Steven D, Dahme T, Busch M, Tilz RR, Schaack D, Rillig A, Sohns C, Sultan A, Weinmann-Emhardt K, Hummel A, Vogler J, Fink T, Lueker J, Pott A, Heeger C, Chun KRJ. Ablation Strategies for Repeat Procedures in Atrial Fibrillation Recurrences Despite Durable Pulmonary Vein Isolation: The Prospective Randomized ASTRO AF Multicenter Trial. Circulation. 2024 Dec 17;150(25):2007-2018. doi: 10.1161/CIRCULATIONAHA.124.069993. Epub 2024 Oct 7.
PubMed 39371020
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences
- ClinicalTrials.gov ID
- NCT04056390
- Acronym / sponsor ID
- ASTRO AF / SF124/2017
- Conditions
- Atrial Fibrillation
- Keywords
- catheter ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Collaborators
- Medtronic, CRO Kottmann
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 14 Aug 2019 (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 aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation.
The present study is a multi-centre prospective randomized study enrolling 256 patients with drug-refractory AF despite previous AF ablation.
After PV remapping confirming durable PVI patients will be assigned to 2 different groups: Group A: Substrate modification.
After obtaining a voltage map of the LA, substrate modification will be performed aiming at low-voltage areas (LVA) < 0.5mV.
Group B: LAA isolation. Patients will undergo LAA-isolation using the cryoballoon (CB). Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (CARTO, EnSite) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance).
The primary endpoint is freedom from documented recurrence of AF or any atrial tachyarrhythmia lasting > 30 seconds between day 91 and 365 after the index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Substrate Modification | Active comparator | Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energyAfter obtaining a voltage map of the LA, substrate modification by catheter ablation using an irrigated radio frequency current ablation catheter will be performed aiming at low-voltage areas (LVA) < 0.5mV. |
| LAA Isolation | Active comparator | Procedure: Catheter ablation using irrigated radiofrequency current ablation or cryothermal energyPatients will undergo LAA-isolation using the cryoballoon (CB). Six weeks later patients will undergo re-mapping. In case of residual conduction LAA-reisolation will be performed. In case of durable LAA isolation, interventional LAA occlusion is recommended. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines.
Key exclusion criteria (13 listed)
- Contraindications for repeat ablation
- Reconnected pulmonary veins according to mapping results with a spiral mapping catheter
- Minimal diameter of LAA neck ≥25mm
- History of mitral valve surgery
- Severe mitral valve regurgitation
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 |
|---|---|---|
| Catheter ablation using irrigated radiofrequency current ablation or cryothermal energySubstrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation. | Procedure or surgery | LAA Isolation, Substrate Modification |
Primary outcome
Arrhythmia Recurrence
Time frame: Day 91-365 after index ablation
Freedom from AF/AT
2 secondary outcomes
Incidence of periprocedural complications
Time frame: day 0 - day 365
Number of electrical cardioversions and hospitalizations
Time frame: day0 - day 365
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 39371020Schmidt B, Bordignon S, Metzner A, Sommer P, Steven D, Dahme T, Busch M, Tilz RR, Schaack D, Rillig A, Sohns C, Sultan A, Weinmann-Emhardt K, Hummel A, Vogler J, Fink T, Lueker J, Pott A, Heeger C, Chun KRJ. Ablation Strategies for Repeat Procedures in Atrial Fibrillation Recurrences Despite Durable Pulmonary Vein Isolation: The Prospective Randomized ASTRO AF Multicenter Trial. Circulation. 2024 Dec 17;150(25):2007-2018. doi: 10.1161/CIRCULATIONAHA.124.069993. Epub 2024 Oct 7.
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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.
Boris Schmidt, MD principal investigator
Cardioangiologisches Centrum Bethanien
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy in people with Atrial Fibrillation, run by Cardioangiologisches Centrum Bethanien at 7 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 6 inclusion and 13 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
Arrhythmia Recurrence (time frame: Day 91-365 after index ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04056390, which also lists 1 linked publication.
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 Nov 2023.