Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures

NCT ID: NCT06403527

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1836 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-03

Study Completion Date

2025-12-03

Brief Summary

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

Detailed Description

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Conditions

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Puncture for Safe Atrial Fibrillation Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Investigator-initiated, prospective, randomized, interventional, multicenter trial
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Interventional arm

Ultrasound guided venous access during AF ablation

Group Type ACTIVE_COMPARATOR

Ultrasound guided venous access during AF ablation

Intervention Type OTHER

Ultrasound guided venous access during AF ablation

Control

Conventional venous puncture guided by palpation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound guided venous access during AF ablation

Ultrasound guided venous access during AF ablation

Intervention Type OTHER

Other Intervention Names

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Ultrasound

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardioangiologisches Centrum Bethanien

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neda Tarighi, Doctor

Role: STUDY_CHAIR

CCB

Locations

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Boris Schmidt

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Boris Schmidt, Prof.

Role: CONTACT

069945028 ext. 146

Julian Chun, Prof.

Role: CONTACT

069945028 ext. 146

Facility Contacts

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Boris Schmidt, Professor

Role: primary

069945028 ext. 146

Julian Chun, Professor

Role: backup

069945028 ext. 146

Other Identifiers

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ULYSSES

Identifier Type: -

Identifier Source: org_study_id

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