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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04586881
• Other study ID #: HDZ_ER001_CS
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum	Bad Oeynhausen

Sponsors (2)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia	Biosense Webster, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF recurrence	recurrence of atrial fibrillation after catheter ablation	12 months