NCT05812261Completed
Lesion Characteristics After Pulsed-Field Ablation in Patients With Atrial Fibrillation and a Left Common Ostium
Source: ClinicalTrials.gov · Last updated 6 Mar 2024
Brief summary (registry, in English)
This study aims to investigate the lesion characteristics after pulmonary vein isolation using pulsed-field ablation in patients with atrial fibrillation and a common of the left pulmonary veins. The main question it aims to answer is: In which percentage of the patients will pulsed field ablation result in successful isolation of the left common ostium? Nineteen patients will be prospectively included in OLVG. All patients will be treated with pulsed-field ablation (routine care). After the ablation procedure, an electro-anatomical map will be created using the ablation catheter and a mapping system. This map will display the left atrium and the lesion in detail. After the procedure, three experienced operators are asked to draw a line around the LCO in the anatomical map where they would have ablated if conventional radiofrequency ablation was used. The distance between the drawn line and the ablation lesion will be measured at three predefined points. The lesion is considered successful if the mean distance is within ±10mm at all measurement points.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 24 (actual)
- First submitted
- 2 Apr 2023
- Start date
- 19 Jul 2023
- Primary completion date
- 29 Feb 2024
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Diseases
- Atrial fibrillation
- NCT number
- NCT05812261
What you commit to
- Study type: Observational
- Participants enrolled: 24
- From 19 Jul 2023 to the primary completion date, 29 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial infarction within three months before the procedure
- Percutaneous coronary interventions within three months before the procedure
- Sudden cardiac death event within three months before the procedure
- History of a thromboembolic event within six months before the procedure
- Previous left atrium ablation, except successful accessory pathway ablation
Other illness
- Left atrial volume index ≥ 60 ml/m2 within 12 months on MRI or cardiac echo
- New York Heart Association heart failure class III or IV
- Unstable angina pectoris
- History of blood clotting or bleeding abnormalities
- Clinical significant infection
- Unstable clinical significant medical condition
- Presence of a prosthetic heart valve
Age
- Patients aged \< 18
Other
- Body mass index \> 35kg/m2
- A life expectancy of less than one year
- Presence of an atrial tachycardia other than cavotricuspid isthmus-dependent atrial flutter
- A contraindication to anticoagulant
- Presence of a left appendage closure device
- Presence of an atrial septum occluder
- Occlusion of the inferior venous tract
- Enrolment in another study that would interfere with this study
Who the study is looking for
- Age \> 18 years of age on the day of enrolment of either sex
- Willing to the sign informed consent
- Left atrial volume index measured \< 60 ml/m2 within last 12 months
- Documented atrial fibrillation
- Admitted and accepted for PVI
- A left common ostium of the pulmonary veins identified by CT or MRI
- Accepted to receive general anaesthesia
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OLVG Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.