Atrial FibrillationNCT04586881
Catch me if You Can - the Individual Relationship Between Potential Ablation Targets From CARTOFINDER and Myocardial Fibrosis
An observational study of Atrial Fibrillation, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
Single center observational study to compare the relationship between atrial fibrosis and potential ablation targets from CARTOFINDER. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2020to 1 Mar 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
Bad Oeynhausen, 32545
About this study
Single center observational study to compare the relationship between atrial fibrosis and potential ablation targets from CARTOFINDER.
Read the 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrence
recurrence of atrial fibrillation after catheter ablation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586881
- Sponsor's protocol ID
- HDZ_ER001_CS
- Status last verified
- Mar 2023
- First submitted
- 7 Oct 2020
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37885302
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catch me if You Can - the Individual Relationship Between Potential Ablation Targets From CARTOFINDER and Myocardial Fibrosis
- ClinicalTrials.gov ID
- NCT04586881
- Acronym / sponsor ID
- HDZ_ER001_CS
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AF recurrence
Time frame: 12 months
recurrence of atrial fibrillation after catheter ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Derived from this study: PubMed 37885302Guckel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04586881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.