Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.

Summary

Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. To prevent strokes, patients with atrial fibrillation and status post ICB can be treated with anticoagulants. This medication therapy prevents blood clots from forming in the heart, but can also cause bleeding. Another therapy option is the occlusion of the left atrium. After closure of the left atrium, only a short anticoagulation therapy is necessary until the occluder has healed. The aim of the study is to compare these two treatment approaches. In this study only already approved drugs and occlusion systems will be used.

Conditions

• Intracranial Hemorrhages
• Atrial Fibrillation (AF)
• Atrial Flutter

Interventions

DEVICE

Percutaneous closure of the LAA (Watchman / Watchman FLX)

LAA closure procedure will be done by experienced operators according to the local SOP. LAA closure will be performed under fluoroscopic and TEE guidance within conscious sedation or general anesthesia. Antibiotic single-shot prophylaxis should be administered peri-procedurally (i.e., cefazolin 2 g). The specific anatomy of the LAA is evaluated and an appropriately sized CE-marked device (Watchman or Watchman FLX) is deployed. LAA angiography and TEE imaging is performed to identify optimal positioning of the device and to exclude a relevant leak. Following device deployment, patients will receive a therapy according to the manufacturers IFU, currently Aspirin and clopidogrel for 3 months followed by single Aspirin up to 12 months. Alternatively, 3 months of NOAC followed by Aspirin monotherapy up to 12 months are possible.

Sponsors & Collaborators

• KCRI

  collaborator OTHER

• Jena University Hospital

  lead OTHER

Principal Investigators

• Sven Möbius-Winkler, Prof. Dr. · Department of Internal Medicine I, Jena University Hospital

• Albrecht Günther, Dr. · Department of Neurology, Jena University Hospital

• Christian Senft, Prof. Dr. · Department of Neurosurgery, Jena University Hospital

• P. Christian Schulze, Prof. Dr. · Department of Internal Medicine I, Jena University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-16

Primary Completion

2029-06-30

Completion

2029-12-31

FDA Device

Yes

Countries

• Germany
• Poland

Study Locations