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COCONUT Study Concomitant PVI and LAAC

COnCOmitaNt Pulse Field Ablation Based pUlmonary Vein Isolation and lefT Atrial Appendage Closure - The COCONUT Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06861673
Acronym
COCONUT
Enrollment
60
Registered
2025-03-06
Start date
2025-03-01
Completion date
2026-12-01
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Brief 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 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.

Interventions

DEVICEPulmonary vein isolation

concomitant PVI and LAAC

Sponsors

Asklepios proresearch
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Indicatio for PVI and LAAC

Exclusion criteria

Not eligible for any of the procedures PVI and LAAC

Design outcomes

Primary

MeasureTime frameDescription
Safetywithin 3 daysPeri- and postprocedural complications: Rate of: pericardial tamponade, pericardial effusion, Venouse access site haematoma
Efficacyone yearSinus rhythm after one year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026