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New treatment option for Persistent or Long-standing Persistent Atrial Fibrillation
Official title Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
ClinicalTrials.gov ID: NCT04240366
What this study is testing
- What it's testing
- Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained \>7 days or \>12 months, respectively)
- Age ≥18 and ≤80 years
- Indication for AF ablation as per current guidelines
You likely can't join if
- Missing informed consent
- LAA diameter \>25mm 10mm distant from circumflex artery assessed by TEE
- Paroxysmal atrial fibrillation
- Long-standing persistent atrial fibrillation with a continuous AF duration of \>4 years
- Previous pulmonary vein isolation or MAZE surgery
- Previous led atrial appendage closure or surgical excision
See the full eligibility criteria
- Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained \>7 days or \>12 months, respectively)
- Age ≥18 and ≤80 years
- Indication for AF ablation as per current guidelines
- Missing informed consent
- LAA diameter \>25mm 10mm distant from circumflex artery assessed by TEE
- Paroxysmal atrial fibrillation
- Long-standing persistent atrial fibrillation with a continuous AF duration of \>4 years
- Previous pulmonary vein isolation or MAZE surgery
- Previous led atrial appendage closure or surgical excision
- Left atrial diameter \>60 mm at baseline
- Left atrial thrombus at baseline
The study team makes the final eligibility decision.
Where it's taking place
- Hamburg, Free and Hanseatic City of Hamburg, Germany
- Lübeck, Schleswig-Holstein, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamburg, Free and Hanseatic City of Hamburg, Germany; Lübeck, Schleswig-Holstein, Germany. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.