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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

• Study Contact: Name: Astrid KIeemeyer; Phone Number: 49 5731 971258; Email: akleemeyer@hdz-nrw.de

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 20 consecutive patients with drug-refractory persistent AF will be included in this prospective observational analysis. AF will be defined as persistent if episodes lasted > 7 days or required electrical or pharmacological cardioversion after ≥ 48 h from onset. All patients will be treated for AF at the Heart and Diabetes Center NRW, Bad Oeynhausen, Germany. Written informed will be obtained from each patient, the study concept complies with the Declaration of Helsinki and the institutional review board already approved the study design. Catheter ablation will be performed under deep sedation. In all patients preprocedural Magnetic Resonance Imaging (MRI) will be performed to guide the intervention, visualize the individual amount and distribution of fibrosis and to visualize the anatomical location and course of the esophagus.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF recurrence	recurrence of atrial fibrillation after catheter ablation	12 months

Collaborators and Investigators

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia
• Collaborators: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: HDZ_ER001_CS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No