Evaluation of Ablation Lesions Using Cardiovascular Magnetic Resonance Imaging

NCT05432024 | Recruiting

• 1 other identifier: RDC-2022.01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Ineffective ablation lesions can cause arrhythmia recurrence after catheter ablation for cardiac arrhythmia. Ablation lesions can be created with various ablation energy modalities. This study uses cardiovascular magnetic resonance imaging to evaluate the ablation lesion characteristics of radiofrequency ablation, ultra-low temperature cryo ablation, and pulsed field ablation. The ablation lesion characteristics of different energy characteristics will be compared. Additionally, arrhythmia recurrence and quality of life will be evaluated for the different energy modalities.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Length of gaps in the ablation lesions

  Cardiovascular magnetic resonance imaging is used to visualize the ablation lesion. If gaps are present in the ablation lesion, the length of the gaps is measured in millimeter.

  At 3 months follow up

Secondary Outcomes (5)

• Number of gaps in the ablation lesion

  At 3 months follow up

• Location of gaps in the ablation lesion

  At 3 months follow up

• Recurrence of atrial arrhythmia

  Until 1 year of follow up

• Atrial arrhythmia burden

  Baseline, 3 and 12 months follow up

• Atrial fibrillation related quality of life

  Baseline, 3 and 12 months follow up

Study Arms (3)

Radiofrequency ablation, High power, short duration

Radiofrequency ablation is an ablation modality that uses radiofrequency energy to create ablation lesions through heat. Patients that are scheduled for pulmonary vein isolation using radiofrequency ablation will be consented for study participation.

Device: Catheter ablation

Ultra-low temperature cryo ablation

Ultra-low temperature cryo ablation is an ablation modality that uses nitrogen near its liquid-vapor critical point to create ablation lesions through ultra-low temperatures. Patients that are scheduled for pulmonary vein isolation using ultra-low temperature cryo ablation will be consented for study participation.

Device: Catheter ablation

Pulsed field ablation

Pulsed field ablation is an ablation modality that uses short lived electrical fields to create ablation lesions through irreversible electroporation. Patients that are scheduled for pulmonary vein isolation using pulsed field ablation will be consented for study participation.

Device: Catheter ablation

Interventions

Catheter ablation DEVICE

An ablation catheter is introduced in the heart. Ablation is performed by applying ablation energy to the target tissue. The aim of ablation is to create an ablation lesion that does not conduct the electrical signals that induce or sustain the cardiac arrhythmia.

Pulsed field ablation; Radiofrequency ablation, High power, short duration; Ultra-low temperature cryo ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The studied population will be drawn from all patients that are scheduled for catheter ablation at the participating center.

You may qualify if:

• Adult patients (age ≥18 years old)
• Paroxysmal or persistent atrial fibrillation, meeting criteria of the 2020 European Society of Cardiology Guidelines for diagnosis and management of atrial fibrillation
• Patients scheduled to undergo catheter ablation for cardiac arrhythmia using one of the following techniques: Radiofrequency ablation (High power, short duration), Ultra-low temperature cryo ablation, or Pulsed field ablation

You may not qualify if:

• Known (or suspected) allergic reaction to gadolinium
• Contraindications for MRI (such as claustrophobia, certain implants, devices, high body mass index).
• Pregnancy or breastfeeding
• Prior intervention in the left atrium (ablation or surgery)

Sponsors & Collaborators

• R&D Cardiologie: lead

Study Sites (1)

St. Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Lucas VA Boersma, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas VA Boersma, MD, PhD

CONTACT

0883200900; l.boersma@antoniusziekenhuis.nl

Bob GS Abeln, MD

CONTACT

0883201212; b.abeln@antoniusziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 27, 2022
• Study Start: March 8, 2023
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

NL (1)