High Power Short Duration Radiofrequency Ablation of Atrial Fibrillation Using the QDOT MICRO™ Catheter

NCT06846502 | Active Not Recruiting

• 2 other identifiers: NL76376.029.21IIS-566
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation; Pulmonary Vein Isolation; Very High Power Short Duration Ablation; Cardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (1)

• Procedure duration

  To study the effect of VHPSD ablation on procedure duration of PVI, compared with conventional Ablation Index-guided ablation.

  Procedure

Study Arms (1)

Paroxysmal or persistent atrial fibrillation patients

EXPERIMENTAL

Procedure: Pulmonary vein isolation

Interventions

Pulmonary vein isolation PROCEDURE

Compared to conventional radiofrequency (RF) ablation, which is performed with a power set of 30-40 Watt for a duration of 20-30 seconds, ablation with higher power and shorter duration (vHPSD, 90W/4sec) may result in more continuous and more durable ablation lesions with a similar safety profile, while reducing procedure duration.

Paroxysmal or persistent atrial fibrillation patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 \< 30 ml/min)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 26, 2025
• Study Start: June 21, 2023
• Primary Completion: October 28, 2024
• Study Completion: November 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-01

Locations

NL (1)