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OpenTrials
Completed

NCT Number: NCT04586881

Catch me if You Can - the Individual Relationship Between Potential Ablation Targets From CARTOFINDER and Myocardial Fibrosis

Single center observational study to compare the relationship between atrial fibrosis and potential ablation targets from CARTOFINDER.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

About this study

A total number of 30 patients will undergo catheter Ablation for persistent AF. Pre-procedural cardiac MRI will be performed with late-gadolinium enhancement to visualize the individual amount and distribution of fibrosis in the right and left atrium. CARTOFINDER-guided mapping will be performed during the ablation procedure followed by AF ablation. The individual relationship between atrial fibrosis and potential ablation targets will be accessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing their 1st AF ablation procedure for persistent atrial fibrillation (AF) as per recent Heart Rhythm Society (HRS) consensus document
  • Able to understand and willing to sign the Informed Consent Form.
  • Age ≥18 years.

Exclusion criteria

  • Contraindication for DE-MRI with a full dose of Gadolinium-based contrast agent.
  • Previous left atrial ablation or surgical procedure
  • Renal failure with CrCl <60 ml/min
  • Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception
  • Mental or physical inability to take part in the study
  • Uncontrolled hypertension
  • Morbid obesity (BMI > 35), or inability to be placed in MRI due to body mass.

Treatment and study plan

Primary outcomes

  1. AF recurrence

    Time frame: 12 months

    recurrence of atrial fibrillation after catheter ablation

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 14, 2020
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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