Health TrialsbyHealthPanel

Concomitant PFA Bsaed PVI Plus LAAC

ConditionsAtrial Fibrillation (AF)BleedingStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsklepios proresearch

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Willing to participate

Atrial fibrillation and indication for PVI (ESC guideline 2024)

Indication for OAC therapy (CHA2DS2VA score >/=2)

Disqualifiers

Contraindications for PVI and / or LAA closure

Pregnancy

Previous catheter ablation for AF

Trial design

Design model

Single group

Treatments tested in this trial

  • Interventional LAA Closure

    Procedure/Surgery

    LAA Closure to prevent stroke and bleeding

  • Pulmonary vein isolation

    Procedure/Surgery

    Pulmonary vein isolation for atrial firbrillation treatment

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Concomitant PVI plus LAACExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

• Primary safety endpoint: Major complications, (SAE) within 30 days

Time frame
30 days
2

• Primary efficacy endpoint: Acute success of PVI and LAA closure

Time frame
30 days
3

• Primary efficiency endpoint: Duration of hospital stay (nights) within 30 days

Time frame
30 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asklepios proresearch

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: