Persistent Atrial FibrillationHybrid-AFMAPNCT05077670
Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm
An observational study of Persistent Atrial Fibrillation, run by Fundacion para la Innovacion en Biomedicina (FIBMED) at 1 site in Spain.
Trial summary
The primary objective of this study is twofold, first we aim to identify rotors in atrial fibrillation (AF) and analyze their relationship with the left atrium-left atrial appendage (LA-LAA) connections. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Pulmonary vein electrical isolation and Atrial substrate mapping
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 1 Sep 2023
- How long will I take part?
- 1 Year
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: The study will include 50 patients. No statistical considerations were made to determine the sample size of this study.
Who may be able to join
- Persistent atrial fibrillation
- The patient has signed the informed consent form
- No LAA previous ablation procedure
- No valvular disease
- LVEF ≥ 35% prior to recruitment
- Age ≥ 18 years
Who cannot join
- LVEF < 35 %
- Hyperthyroidism or hypothyroidism
- Mental or physical illness incapacitation
- Planned cardiac procedure
- Non-controlled hypertension
- Terminal renal failure or dialysis
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- Class IV of the NYHA
- Age ≥ 75 years
- Life expectancy < 2 years
- Atrioventricular block
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm With CARTOFINDER and COHERENT Mapping
The primary objective of this study is twofold, first we aim to identify rotors in atrial fibrillation (AF) and analyze their relationship with the left atrium-left atrial appendage (LA-LAA) connections. Secondly, we will analyze the areas harboring rotors in SR to define the characteristics that describe the presence of rotors.
Read the detailed description
The primary objective of this study is the identification of LA and LAA areas driving atrial fibrillation to study their relationship with LAA-LA connections and sinus rhythm (SR) analysis using the CartoFinder and COHERENT algorithms that CARTO V7 offers.
The CartoFinder tool will be able to determine the activation patterns of reentrant drivers (rotors) in the LA and LAA in AF. The characterization of areas harboring rotors could be performed with the COHERENT tool provided by CARTO V7 to determine the activation patterns during reentrant rhythms, and after sinus rhythm restoration it could be used to assess the conduction patterns at LA-LAA connections and driver sites identified with CartoFinder.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Pulmonary vein electrical isolation, Atrial substrate mapping
- Keywords
- Atrial fibrillation, Catheter ablation, Rotors
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein electrical isolationProcedure or surgery
Also called Pulmonary veins ablation
Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy.
Atrial substrate mappingDevice
Also called Electro-anatomical mapping
Electro-anatomical maps will be performed with CARTO navigation system with multi-electrode catheters.
| Study group | Role | What they receive |
|---|---|---|
| Study group | * LAA + LA Map in AF
* Identify LAA connections and detect rotors with CartoFinder
* Electrical cardioversion. Sinus rhythm restoration
* Pacing from the coronary sinus at 300 and 600ms periods
* Analyze COHERENT activation maps in sinus rhythm
* Ablation as suggested by current clinical guidelines and the characteristics of the patient Receives: Procedure: Pulmonary vein electrical isolation; Device: Atrial substrate mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
CartoFinder and COHERENT tools utility assessment
To evaluate the utility of CartoFinder and COHERENT tools in the identification of the mechanisms that maintain atrial fibrillation.
Measured: 2 years
Secondary outcomes (1)
Atrial fibrillation driver location analysis
Reentrant driver location relationship with lines of block, wavefront curvature, and slow conduction areas during SR pacing with success AF termination.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundacion para la Innovacion en Biomedicina (FIBMED)
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
- Investigators
- Ángel Arenal, MD, PhD, Principal investigator, Hospital General Universitario Gregorio MarañonGonzalo R Ríos-Muñoz, MSc, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077670
- Sponsor's protocol ID
- Hybrid-AFMAP
- Acronym
- Hybrid-AFMAP
- Status last verified
- Dec 2022
- First submitted
- 1 Oct 2021
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm With CARTOFINDER and COHERENT Mapping
- ClinicalTrials.gov ID
- NCT05077670
- Acronym / sponsor ID
- Hybrid-AFMAP / Hybrid-AFMAP
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Atrial fibrillation, Catheter ablation, Rotors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacion para la Innovacion en Biomedicina (FIBMED)University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 14 Oct 2021 (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.
The primary objective of this study is twofold, first we aim to identify rotors in atrial fibrillation (AF) and analyze their relationship with the left atrium-left atrial appendage (LA-LAA) connections. Secondly, we will analyze the areas harboring rotors in SR to define the characteristics that describe the presence of rotors.
Detailed description
The primary objective of this study is the identification of LA and LAA areas driving atrial fibrillation to study their relationship with LAA-LA connections and sinus rhythm (SR) analysis using the CartoFinder and COHERENT algorithms that CARTO V7 offers.
The CartoFinder tool will be able to determine the activation patterns of reentrant drivers (rotors) in the LA and LAA in AF. The characterization of areas harboring rotors could be performed with the COHERENT tool provided by CARTO V7 to determine the activation patterns during reentrant rhythms, and after sinus rhythm restoration it could be used to assess the conduction patterns at LA-LAA connections and driver sites identified with CartoFinder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Pulmonary vein electrical isolation, Device: Atrial substrate mapping* LAA + LA Map in AF * Identify LAA connections and detect rotors with CartoFinder * Electrical cardioversion. Sinus rhythm restoration * Pacing from the coronary sinus at 300 and 600ms periods * Analyze COHERENT activation maps in sinus rhythm * Ablation as suggested by current clinical guidelines and the characteristics of the patient |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will include 50 patients. No statistical considerations were made to determine the sample size of this study.
Key inclusion criteria (6 listed)
- Persistent atrial fibrillation
- The patient has signed the informed consent form
- No LAA previous ablation procedure
- No valvular disease
- LVEF ≥ 35% prior to recruitment
Key exclusion criteria (11 listed)
- LVEF < 35 %
- Hyperthyroidism or hypothyroidism
- Mental or physical illness incapacitation
- Planned cardiac procedure
- Non-controlled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary vein electrical isolationAlso: Pulmonary veins ablationElectrical isolation of the pulmonary veins from the left atrium with cryoablation therapy. | Procedure or surgery | Study group |
| Atrial substrate mappingAlso: Electro-anatomical mappingElectro-anatomical maps will be performed with CARTO navigation system with multi-electrode catheters. | Device | Study group |
Primary outcome
CartoFinder and COHERENT tools utility assessment
Time frame: 2 years
To evaluate the utility of CartoFinder and COHERENT tools in the identification of the mechanisms that maintain atrial fibrillation.
1 secondary outcome
Atrial fibrillation driver location analysis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- 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.
Ángel Arenal, MD, PhD principal investigator
Hospital General Universitario Gregorio Marañon
Gonzalo R Ríos-Muñoz, MSc, PhD principal investigator
Hospital General Universitario Gregorio Marañon
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 Persistent Atrial Fibrillation, run by Fundacion para la Innovacion en Biomedicina (FIBMED) at 1 site in Spain.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Dec 2022. 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 Spain. 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?
Results are not available in the source record.
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?
CartoFinder and COHERENT tools utility assessment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2022.