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NCT06846502Active, not recruiting

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 STUDY

Source: ClinicalTrials.gov · Last updated 26 Feb 2025

Brief summary (registry, in English)

Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide, characterized by rapid and disorganized atrial activation leading to an irregular heart rhythm. Pulmonary vein isolation (PVI) ablation is the gold standard for catheter ablation based therapy. However, recurrence of AF after PVI is common, often due to the inability to create durable ablation lesions surrounding the pulmonary veins (PV). Conventional radiofrequency (RF) ablation is typically performed with power set at 30-40 Watt for a duration of 20-30 seconds. Previous studies have shown that ablation with very higher power and shorter duration (vHPSD, 90W/4sec) may result in more continuous and more durable ablation lesions with a similar safety profile as compared to conventional ablation lesions. This new technique may consequently improve outcomes of RF ablation for AF. Moreover, HPSD ablation of AF may significantly reduce RF duration, which could lead to shorter anaesthesia, fluoroscopy and procedure duration. Cardiac magnetic resonance imaging (CMR) enables studying cardiac volumes, function and atrial tissue characteristics. By applying this imaging strategy before ablation, and directly (\<72 hours) and later (3 months) after ablation, transient (edema) and persistent (fibrosis) effects of RF ablation in the left atrial wall and surrounding tissues may be visualized and quantified. The Q-POWER study aims to assess the effects of VHPSD RF ablation on 1) procedural characteristics, 2) acute and long-term ablation lesion formation and collateral tissue damage as assessed by CMR and 3) clinical outcomes in AF patients.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
42 (actual)
First submitted
20 Feb 2025
Start date
21 Jun 2023
Primary completion date
28 Oct 2024
Lead sponsor
Amsterdam UMC, location VUmc
NCT number
NCT06846502

What you commit to

  • Study type: Interventional
  • Participants enrolled: 42
  • From 21 Jun 2023 to the primary completion date, 28 Oct 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

  • Prior left atrial ablation
  • Prior left atrial surgery

Other illness

  • Other left atrial arrhythmias including atrial flutters
  • Contraindications for CMR (including metallic implants, cochlear implants, cardiac devices, neurostimulation systems, claustrophobia)

Lab values

  • Renal insufficiency (eGFR \< 30 ml/min)

Other

  • Unwilling or unable to give written informed consent
  • Severe mitral valve regurgitation
  • Contraindication for gadolinium-based contrast agents

Who the study is looking for

  • \>18 years of age
  • AF and eligible for index PVI according to current ESC guidelines

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.