Atrial Fibrillation (AF)COCONUT_2NCT07450755
Concomitant PFA Bsaed PVI Plus LAAC
A study testing Interventional LAA Closure and Pulmonary vein isolation in people with Atrial Fibrillation (AF) and Bleeding, run by Asklepios proresearch.
Trial summary
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy and efficiency of this approach (COCONUT II study). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Bleeding, Stroke
- What is being tested?
- Interventional LAA Closure and Pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2027
- 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
- Age ≥ 18 years
- Willing to participate
- Atrial fibrillation and indication for PVI (ESC guideline 2024)
- Indication for OAC therapy (CHA2DS2VA score >/=2)
Who cannot join
- Contraindications for PVI and / or LAA closure
- Pregnancy
- Previous catheter ablation for AF
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pulse Field Ablation Based Pulmonary Vein Isolation Concomitant With Left Atrial Appendage Closure - The COCONUT II Study
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy and efficiency of this approach (COCONUT II study). If available the transseptal puncture will be performed by the VersaCross System (Boston scientific). If already available LAAC procedure will be performed utilizing the Watchman Flx pro device (Boston scientific) or the Watchman Flx device (Boston scientific).
For procedure planning, assessment of the LAA size and selection of the Watchman Flx device a preprocedural cardiac computed tomography in combination with the TruePLan Software is recommended.
Read the detailed description
The objective is to invite high-volume centers in Germany to submit the procedural and periprocedural data, as well as the 12-months follow-up data in a secure and standardized way. In comparison to the most registries conducted today, a dedicated database comprising a standardized questionnaire, as well as multiple data validation processes at different levels in order to assure a better data quality is used.
The aim of the COCONUT II study will collect data of a concomitant PFA based PVI and LAAC approach to treat AF and prevent bleeding and stroke within 12 months. 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), Bleeding, Stroke
- Being tested
- Interventional LAA Closure, Pulmonary vein isolation
- Keywords
- Catheter ablation, Pulsed field ablation, LAAClosure
- Medical subject headings
- Atrial Fibrillation, Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional LAA ClosureProcedure or surgery
LAA Closure to prevent stroke and bleeding
Pulmonary vein isolationProcedure or surgery
Pulmonary vein isolation for atrial firbrillation treatment
| Study group | Role | What they receive |
|---|---|---|
| Concomitant PVI plus LAAC | Experimental | Not described Receives: Procedure: Interventional LAA Closure; Procedure: Pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Primary safety endpoint: Major complications, (SAE) within 30 days
Measured: 30 days
• Primary efficacy endpoint: Acute success of PVI and LAA closure
Measured: 30 days
• Primary efficiency endpoint: Duration of hospital stay (nights) within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
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
- NCT07450755
- Sponsor's protocol ID
- COCONUT_2 Study
- Acronym
- COCONUT_2
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 12 Mar 2026
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Field Ablation Based Pulmonary Vein Isolation Concomitant With Left Atrial Appendage Closure - The COCONUT II Study
- ClinicalTrials.gov ID
- NCT07450755
- Acronym / sponsor ID
- COCONUT_2 / COCONUT_2 Study
- Conditions
- Atrial Fibrillation (AF), Bleeding, Stroke
- Keywords
- Catheter ablation, Pulsed field ablation, LAAClosure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Asklepios proresearchIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Mar 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.
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy and efficiency of this approach (COCONUT II study). If available the transseptal puncture will be performed by the VersaCross System (Boston scientific). If already available LAAC procedure will be performed utilizing the Watchman Flx pro device (Boston scientific) or the Watchman Flx device (Boston scientific).
For procedure planning, assessment of the LAA size and selection of the Watchman Flx device a preprocedural cardiac computed tomography in combination with the TruePLan Software is recommended.
Detailed description
The objective is to invite high-volume centers in Germany to submit the procedural and periprocedural data, as well as the 12-months follow-up data in a secure and standardized way. In comparison to the most registries conducted today, a dedicated database comprising a standardized questionnaire, as well as multiple data validation processes at different levels in order to assure a better data quality is used.
The aim of the COCONUT II study will collect data of a concomitant PFA based PVI and LAAC approach to treat AF and prevent bleeding and stroke within 12 months. 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective study
| Arm | Type | Receives |
|---|---|---|
| Concomitant PVI plus LAAC | Experimental | Procedure: Interventional LAA Closure, Procedure: Pulmonary vein isolation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Willing to participate
- Atrial fibrillation and indication for PVI (ESC guideline 2024)
- Indication for OAC therapy (CHA2DS2VA score >/=2)
Key exclusion criteria (3 listed)
- Contraindications for PVI and / or LAA closure
- Pregnancy
- Previous catheter ablation for AF
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 |
|---|---|---|
| Interventional LAA ClosureLAA Closure to prevent stroke and bleeding | Procedure or surgery | Concomitant PVI plus LAAC |
| Pulmonary vein isolationPulmonary vein isolation for atrial firbrillation treatment | Procedure or surgery | Concomitant PVI plus LAAC |
Primary outcome
• Primary safety endpoint: Major complications, (SAE) within 30 days
Time frame: 30 days
• Primary efficacy endpoint: Acute success of PVI and LAA closure
Time frame: 30 days
• Primary efficiency endpoint: Duration of hospital stay (nights) within 30 days
Time frame: 30 days
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 12 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.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional LAA Closure and Pulmonary vein isolation in people with Atrial Fibrillation (AF) and Bleeding, run by Asklepios proresearch.
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 3 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Christian-Hendrik Heeger, MD (0049-40-181881-8904, c.heeger@asklepios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Primary safety endpoint: Major complications, (SAE) within 30 days (time frame: 30 days). The study lists 3 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 12 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.