Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures

Cardioangiologisches Centrum Bethanien1,075 enrolled

Overview

To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

1,075

Conditions

Puncture for Safe Atrial Fibrillation Ablation

Interventions

Ultrasound guided venous access during AF ablationOTHER

Ultrasound guided venous access during AF ablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Inclusion Criteria 1. Age ≥18 years 2. Signed written informed consent 3. Planned transvenous catheter ablation procedure for AF or left atrial tachycardia 4. Willingness to participate in follow-up Exclusion Criteria 1. Patient is unable or unwilling to provide informed consent 2. Planned/required arterial access (e.g. for blood pressure monitoring) 3. Patient has contra-indication to oral anticoagulation 4. Known coagulation disorder or Thrombocytopenia \<150.000/ul. 6\. Women currently pregnant or breastfeeding or women of childbearing potential without highly effective contraception (PEARL-Index \< 1%), 7. Patient is included in another clinical trial 8. Inability to comply with the study procedures

Locations (1)

Boris Schmidt

Frankfurt am Main, Hesse, Germany

Outcomes

Primary Outcomes

occurrence of venous access site complications

occurrence of venous access site complications until 30 days after the procedure defined as AV fistula, false aneurysm or access site bleeding requiring intervention (BARC 3 A or higher)

Time frame: 30 days

Data from ClinicalTrials.gov

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