Atrial Fibrillation (AF)COCONUTNCT06861673
COCONUT Study Concomitant PVI and LAAC
An observational study of Atrial Fibrillation (AF), run by Asklepios proresearch at 1 site in Germany.
Trial summary
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and registries.8 While PVI and LAAC are both conducted in the left atrium and share the same access… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Pulmonary vein isolation
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2025to 1 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with AF and PVI plus LAAC
Who may be able to join
- Indicatio for PVI and LAAC
Who cannot join
- Not eligible for any of the procedures PVI and LAAC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg
Christian-Hendrik Heeger, Prof. Dr., 0049401818818904, c.heeger@asklepios.com
About this study
Official title: COnCOmitaNt Pulse Field Ablation Based pUlmonary Vein Isolation and lefT Atrial Appendage Closure - The COCONUT Study
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and registries.8 While PVI and LAAC are both conducted in the left atrium and share the same access route, a combined concomitant approach might be beneficial for patients but is not conventionally practiced. Due to significantly shorter procedures times and high safety profile PFA based catheter ablation may be advantageous for the combined approach of PVI and LAAC. We are performing a word-wide, retrospective, multicenter registry study focusing on patients with concomitant Farapulse PFA based PVI and LAAC (WATCHMAN Flx, Boston Scientific). To evaluate safety, efficacy and efficiency in a multicenter study the COCONUT study was conducted.
Read the detailed description
Atrial fibrillation (AF) ablation by pulmonary vein isolation and left atrial appendage closure (LAAC) are increasingly performed as individual procedures. However, there are several studies which investigated a combined concomitant approach of perfoming a cryoballoon or radiofrequency based PVI and an interventional LAAC in one procedure and safety and efficacy has been shown. 1,2,3,4 The novel ablation modality pulsed field ablation (PFA) has significantly reduced procedure duration and potentially increased safety due a specific ablation of cardiac tissue with sparing smooth muscle cells and nervous cells.6 With currently >100.000 treated patients most experience is currently available for the Farapulse PFA system (Boston Scientific). The MANIFEST-PF and MANIFEST 17K registries showed an excellent safety and efficacy profile of this novel ablation technology.6,7 In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and registries.8 While PVI and LAAC are both conducted in the left atrium and share the same access route, a combined concomitant approach might be beneficial for patients but is not conventionally practiced. Due to significantly shorter procedures times and high safety profile PFA based catheter ablation may be advantageous for the combined approach of PVI and LAAC. We are performing a word-wide, retrospective, multicenter registry study focusing on patients with concomitant Farapulse PFA based PVI and LAAC (WATCHMAN Flx, Boston Scientific). To evaluate safety, efficacy and efficiency in a multicenter study the CONOCNUT study was conducted. Two months after successful PVI and LAAC the OAC therapy could be terminated which might be beneficial for the patients especially for those with a higher bleeding risk. Further potential benefits are the reduction of periprocedural complications. Furthermore, economic factors could be beneficial due to only one concomitant procedure with one hospital stay instead of two procedures with two hospital stays.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationDevice
concomitant PVI and LAAC
| Study group | Role | What they receive |
|---|---|---|
| Concomitant PVI plus LAAC | Not described Receives: Device: Pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Peri- and postprocedural complications:
Rate of: pericardial tamponade, pericardial effusion, Venouse access site haematoma
Measured: within 3 days
Efficacy
Sinus rhythm after one year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Asklepios proresearch
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Prof. Christian-Hendrik Heeger, Asklepios proresearch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861673
- Sponsor's protocol ID
- COCONUT register
- Acronym
- COCONUT
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COnCOmitaNt Pulse Field Ablation Based pUlmonary Vein Isolation and lefT Atrial Appendage Closure - The COCONUT Study
- ClinicalTrials.gov ID
- NCT06861673
- Acronym / sponsor ID
- COCONUT / COCONUT register
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asklepios proresearchIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Mar 2025 (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.
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and registries.8 While PVI and LAAC are both conducted in the left atrium and share the same access route, a combined concomitant approach might be beneficial for patients but is not conventionally practiced. Due to significantly shorter procedures times and high safety profile PFA based catheter ablation may be advantageous for the combined approach of PVI and LAAC. We are performing a word-wide, retrospective, multicenter registry study focusing on patients with concomitant Farapulse PFA based PVI and LAAC (WATCHMAN Flx, Boston Scientific). To evaluate safety, efficacy and efficiency in a multicenter study the COCONUT study was conducted.
Detailed description
Atrial fibrillation (AF) ablation by pulmonary vein isolation and left atrial appendage closure (LAAC) are increasingly performed as individual procedures. However, there are several studies which investigated a combined concomitant approach of perfoming a cryoballoon or radiofrequency based PVI and an interventional LAAC in one procedure and safety and efficacy has been shown. 1,2,3,4 The novel ablation modality pulsed field ablation (PFA) has significantly reduced procedure duration and potentially increased safety due a specific ablation of cardiac tissue with sparing smooth muscle cells and nervous cells.6 With currently >100.000 treated patients most experience is currently available for the Farapulse PFA system (Boston Scientific). The MANIFEST-PF and MANIFEST 17K registries showed an excellent safety and efficacy profile of this novel ablation technology.6,7 In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and registries.8 While PVI and LAAC are both conducted in the left atrium and share the same access route, a combined concomitant approach might be beneficial for patients but is not conventionally practiced. Due to significantly shorter procedures times and high safety profile PFA based catheter ablation may be advantageous for the combined approach of PVI and LAAC. We are performing a word-wide, retrospective, multicenter registry study focusing on patients with concomitant Farapulse PFA based PVI and LAAC (WATCHMAN Flx, Boston Scientific). To evaluate safety, efficacy and efficiency in a multicenter study the CONOCNUT study was conducted. Two months after successful PVI and LAAC the OAC therapy could be terminated which might be beneficial for the patients especially for those with a higher bleeding risk. Further potential benefits are the reduction of periprocedural complications. Furthermore, economic factors could be beneficial due to only one concomitant procedure with one hospital stay instead of two procedures with two hospital stays.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concomitant PVI plus LAAC | – | Device: Pulmonary vein isolation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with AF and PVI plus LAAC
Key inclusion criteria (1 listed)
- Indicatio for PVI and LAAC
Key exclusion criteria (1 listed)
- Not eligible for any of the procedures PVI and LAAC
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 |
|---|---|---|
| Pulmonary vein isolationconcomitant PVI and LAAC | Device | Concomitant PVI plus LAAC |
Primary outcome
Safety
Time frame: within 3 days
Peri- and postprocedural complications: Rate of: pericardial tamponade, pericardial effusion, Venouse access site haematoma
Efficacy
Time frame: one year
Sinus rhythm after one year
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 19 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by Asklepios proresearch at 1 site 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 1 inclusion and 1 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 19 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: within 3 days). The study lists 2 primary outcomes in all. 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 19 Mar 2026.