Clinical trial NCT04586881: Catch me if You Can - the Individual Relationship Between Potential Ablation Targets From CARTOFINDER and Myocardial Fibrosis
Official title: Catch me if You Can - the Individual Relationship Between Potential Ablation Targets From CARTOFINDER and Myocardial Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2020-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: AF recurrence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
Study officials:
References: