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Clinical Trials/NCT04586881
NCT04586881CompletedNot Applicable

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

Heart and Diabetes Center North-Rhine Westfalia1 site in 1 country20 target enrollmentStarted: October 1, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
AF recurrence
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

AF recurrence

Time Frame: 12 months

recurrence of atrial fibrillation after catheter ablation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Heart and Diabetes Center North-Rhine Westfalia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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