Atrial Fibrillation Clinical Trial
Official title:
Catch me if You Can - the Individual Relationship Between Potential Ablation Targets From CARTOFINDER and Myocardial Fibrosis
NCT number | NCT04586881 |
Other study ID # | HDZ_ER001_CS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2020 |
Est. completion date | March 1, 2023 |
Verified date | March 2023 |
Source | Heart and Diabetes Center North-Rhine Westfalia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Single center observational study to compare the relationship between atrial fibrosis and potential ablation targets from CARTOFINDER.
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum | Bad Oeynhausen |
Lead Sponsor | Collaborator |
---|---|
Heart and Diabetes Center North-Rhine Westfalia | Biosense Webster, Inc. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AF recurrence | recurrence of atrial fibrillation after catheter ablation | 12 months |
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