COCONUT Study Concomitant PVI and LAAC

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAsklepios proresearch

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients with AF and PVI plus LAAC

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Pulmonary vein isolation

    Device

    concomitant PVI and LAAC

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Concomitant PVI plus LAAC1 intervention

Trial outcomes

Primary outcomes

1

Safety

Peri- and postprocedural complications: Rate of: pericardial tamponade, pericardial effusion, Venouse access site haematoma

Time frame
within 3 days
2

Efficacy

Sinus rhythm after one year

Time frame
one year

Secondary outcomes

Other outcomes

Sponsors and contacts

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