High Power Short Duration Radiofrequency Ablation of Atrial Fibrillation using the QDOT MICRO* Catheter

High Power Short Duration Radiofrequency Ablation of Atrial Fibrillation using the QDOT MICRO* Catheter - Q-POWER

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52104

Enrollment

Registered

2023-04-26

Start date

2023-06-21

Completion date

Unknown

Last updated

2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A-fib Atrial fibrillation

Interventions

Patients will undergo PVI ablation with the QDOT MICRO* catheter using VHPSD-settings (90 watt, 4 seconds). CMR imaging will be performed at 24-48 hours and 3 months follow-up

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: All patients > 18 years of age with atrial fibrillation, eligible for index pulmonary vein isolation according to current ESC guidelines

Exclusion criteria

Exclusion criteria: • Unwilling or unable to give written informed consent • Prior left atrial ablation • Other left atrial arrhythmias including atrial flutters • Prior left atrial surgery • Severe mitral valve regurgitation • Contraindication for gadolinium-based contrast agents • Contraindications for CMR (including metallic implants, cochlear implants, cardiac devices, neurostimulation systems, claustrophobia) • Renal insufficiency (eGFR

Design outcomes

Primary

Measure	Time frame
• procedure duration • presence, location, extent and composition of acute (24-48 hours) and chronic (3 months) ablation lesions on CMR	—

Secondary

Measure	Time frame
• micro-electrode and macro-electrode derived unipolar and bipolar atrial electrograms • procedural fluoroscopy time and radiation dose • percentage single round isolation for each PV pair • acute PV reconnection for each PV pair • percentage freedom from atrial tachyarrhythmias at 1 year12 months follow-up • incidence of procedure related adverse events including: atrio-esophageal fistula, cardiac tamponade/perforation, death, embolic event, esophageal injury, major vascular access complication, myocardial infarction, pericarditis, phrenic nerve injury/diaphragmatic paralysis, pulmonary vein stenosis, stroke/transient ischemic attack	—

Measure

Time frame

• micro-electrode and macro-electrode derived unipolar and bipolar atrial electrograms • procedural fluoroscopy time and radiation dose • percentage *single round* isolation for each PV pair • acute PV reconnection for each PV pair • percentage freedom from atrial tachyarrhythmias at 1 year12 months follow-up • incidence of procedure related adverse events including: atrio-esophageal fistula, cardiac tamponade/perforation, death, embolic event, esophageal injury, major vascular access complication, myocardial infarction, pericarditis, phrenic nerve injury/diaphragmatic paralysis, pulmonary vein stenosis, stroke/transient ischemic attack

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)