Concomitant PFA Bsaed PVI Plus LAAC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interventional LAA Closure, Pulmonary vein isolation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Bleeding, Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pulse Field Ablation Based Pulmonary Vein Isolation Concomitant With Left Atrial Appendage Closure - The COCONUT II Study
Overview
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.
Interventions
- Procedure Interventional LAA Closure
LAA Closure to prevent stroke and bleeding - Procedure Pulmonary vein isolation
Pulmonary vein isolation for atrial firbrillation treatment
Primary outcome measures
- • 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]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Willing to participate
- Atrial fibrillation and indication for PVI (ESC guideline 2024)
- Indication for OAC therapy (CHA2DS2VA score >/=2)
Exclusion criteria
- Contraindications for PVI and / or LAA closure
- Pregnancy
- Previous catheter ablation for AF
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07450755 · COCONUT_2 Study