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

NCT04586881 | Completed

• 1 other identifier: HDZ_ER001_CS
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• AF recurrence

  recurrence of atrial fibrillation after catheter ablation

  12 months

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

Location

Related Publications (1)

• Guckel D, Piran M, Bergau L, Hamriti ME, Fink T, Sciacca V, Reil JC, Braun M, Khalaph M, Imnadze G, Kramer K, Friedrich S, Ruhl J, Korperich H, Sommer P, Sohns C. The individual relationship between atrial fibrillation sources from CARTOFINDER mapping and atrial cardiomyopathy: The catch me if you can trial. Pacing Clin Electrophysiol. 2023 Dec;46(12):1553-1564. doi: 10.1111/pace.14847. Epub 2023 Oct 27.

  PMID: 37885302 DERIVED

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)