Persistent Atrial FibrillationTAILOR-AFNCT05169320
Patient-TAILORed Ablation of Persistent AF Guided by Instantaneous Amplitude and Frequency Modulation Maps (TAILOR-AF)
An observational study of Persistent Atrial Fibrillation, run by Hospital San Carlos, Madrid at 2 sites in Spain.
Trial summary
Pulmonary vein isolation (PVI) is still considered the cornerstone of catheter ablation for patients with persistent atrial fibrillation (AF). However, ablation outcomes in patients with persistent AF are suboptimal with high recurrence rates after a single PVI procedure. 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?
- Subcutaneous implantable loop recorder (ILR) implantation, Mapping and catheter ablation and Minimally invasive surgical ablation via thoracoscopy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 25 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Dec 2021to 30 Dec 2024
- 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: Patients from the Cardiored1 program (including 4 hospitals in Madrid, Spain) with symptomatic persistent AF in spite of ≥2 PVI previous procedures.
Who may be able to join
- Patients with symptomatic persistent AF (defined as a sustained episode lasting ≥ 7 days) despite ≥2 previous PVI, with or without other atrial anatomical targets isolated in previous procedures (e.g. superior vena cava, coronary sinus or others).
- AF episodes refractory to ≥1 antiarrhythmic drug (flecainide, propofenone, amiodarone or droneradore) or adverse events related to antiarrhythmic drugs that do not allow long-term drug therapy.
- Age between 18-75 years old.
- Patients must be willing and able to comply with all peri-ablation and follow-up requirements.
- Signed informed consent.
- Confirmed pulmonary vein isolation in the index (in current protocol) procedure.
Who cannot join
- Patients with paroxysmal AF (defined as a sustained episode lasting < 7 days).
- Patients for whom cardioversion or sinus rhythm will never be attempted/pursued.
- Patients with AF secondary to an obvious reversible cause.
- Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor.
- Non-sustained AF during the mapping procedure.
- Severe underlying systemic disease (e.g. dementia, any end-disease stage, sepsis, etc).
Show all 10Show fewer
- Severe left atrial dilation (left atrial volume >73 ml/m2).
- Severe underlying cardiac disease (e.g. left ventricular ejection fraction ≤35%, severe non-corrected valvular disease, severe non-corrected coronary artery disease, hypertrophic cardiomyopathy, other inherited arrhythmia syndromes, severe dilated cardiomyopathy with NYHA functional class III, IV).
- Hemodynamic instability due to any cardiac or non-cardiac disease.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 1 recruiting
- Active, not recruiting
Centro Nacional de Investigaciones Cardiovasculares (CNIC)
Madrid, 28029
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
David Filgueiras-Rama, MD, PhD, +34 914 531 200 ext. 1510, dfilgueiras@cnic.es
David Filgueiras-Rama, MD, PhD
About this study
Official title: Patient-TAILORed Ablation of Atrial Fibrillation Drivers in Persistent Stages Based on Instantaneous Amplitude and Frequency Modulation Criteria (TAILOR-AF)
Pulmonary vein isolation (PVI) is still considered the cornerstone of catheter ablation for patients with persistent atrial fibrillation (AF). However, ablation outcomes in patients with persistent AF are suboptimal with high recurrence rates after a single PVI procedure.
Recently, the investigators developed a new strategy, which enables precise identification of the driver regions allegedly responsible for the maintenance of persistent AF outside the pulmonary veins. This approach uses a conventional electroanatomical mapping system and novel single-signal algorithms based on automatic and accurate analysis of the instantaneous amplitude and frequency modulations displayed by atrial signals during AF (iAM and iFM, respectively) to locate the spatiotemporally stable regions that drive persistent AF (leading drivers).
Read more
This strategy also enables to identify highly complex substrates in which targeting leading driver regions with catheter-based ablation may not be feasible or could be potentially associated with a significantly higher risk of complications. In such patients, the iAM/iFM maps obtained in the index catheter mapping and ablation procedure will be used to guide an additional patient-specific, minimally invasive surgical ablation approach via thoracoscopy, aiming to completely but specifically target all leading driver regions.
The main objective of the TAILOR-AF study is to identify (via iAM/iFM maps), target and ablate AF leading drivers in patients with symptomatic persistent AF recurrences despite ≥2 previous PVI procedures. The methods include a percutaneous catheter mapping and ablation approach followed by a minimally invasive surgical approach via thoracoscopy, if necessary. As a secondary objective we will study the association of underlying blood biomarkers, atrial imaging and surface ECG parameters, with advanced remodeling stages requiring a surgical approach to target leading driver regions.
This is a single center study (Hospital Clínico San Carlos, Madrid, Spain) that will recruit 25 patients with symptomatic persistent AF episodes despite having been submitted to ≥2 PVI prior procedures. All patients will undergo subcutaneous implantable loop recorder (ILR) implantation to address AF burden 1 month before the ablation procedure and at least 1 year after the ablation procedure. The primary outcome of the study will be AF freedom after one year of follow-up off antiarrhythmic drugs.
Read the detailed description
The study is co-sponsored by the Fundación para la Investigación Biomédica del Hospital Clínico San Carlos (Madrid, Spain) and the Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.) (Madrid, Spain).
Dr. David Filgueiras-Rama (MD, PhD, affiliation: Hospital Clínico San Carlos) and Dr. Jorge G. Quintanilla (MScEng, PhD, affiliation: Centro Nacional de Investigaciones Cardiovasculares [CNIC]) are Co-Principal Investigators of the study.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Subcutaneous implantable loop recorder (ILR) implantation, Mapping and catheter ablation, Minimally invasive surgical ablation via thoracoscopy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous implantable loop recorder (ILR) implantationDevice
All patients will undergo subcutaneous implantable loop recorder (ILR) implantation to quantify AF burden 1 month before the ablation procedure and at least 1 year after the ablation procedure.
Mapping and catheter ablationProcedure or surgery
Driver regions will be identified during persistent AF using a conventional electroanatomical mapping system, multielectrode mapping catheters, and leading-driver maps generated by novel single-signal algorithms based on an automatic and accurate analysis of the instantaneous amplitude and frequency modulations displayed by atrial signals (iAM and iFM, respectively). Such maps enable the location of the spatiotemporally stable regions that drive persistent AF (leading drivers). Leading-driver regions that can be reasonably targeted/isolated with catheter ablation without high-risk of complications upon radiofrequency delivery will be targeted for ablation.
Minimally invasive surgical ablation via thoracoscopyProcedure or surgery
This procedure will be performed only in those patients whose leading-driver maps in the previous mapping and catheter ablation procedure fulfill the following requirements:
- Extensive atrial remodeling who will not likely get any benefit from catheter-based ablation due to too large atrial leading driver areas (≥10-15% of atrial surface), or
- Leading drivers located at regions with high-risk of complications upon radiofrequency delivery (e.g. left and right atrial appendages, coronary sinus, in the vicinity [≤5 mm] of the cardiac specific conduction system).
In such patients, the leading-driver regions not completely targeted or not targeted at all in the previous index mapping and catheter ablation procedure, will be specifically ablated/isolated by minimally invasive surgical ablation techniques via thoracoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Patients with symptomatic persistent AF episodes after previous failure of ≥2 pulmonary vein isolation procedures Receives: Device: Subcutaneous implantable loop recorder (ILR) implantation; Procedure: Mapping and catheter ablation; Procedure: Minimally invasive surgical ablation via thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial Fibrillation without antiarrhythmic drugs
Number/Percentage of participants with freedom from Atrial Fibrillation without antiarrhythmic drugs
Measured: After one year of follow-up
Secondary outcomes (3)
Acute termination of Atrial Fibrillation during the procedure/s
Number/Percentage of participants with acute termination of Atrial Fibrillation during the procedure/s
Measured: During catheter ablation and/or minimally invasive thoracoscopic surgical procedures
Freedom from Atrial Fibrillation with or without antiarrhythmic drugs
Number/Percentage of participants with freedom from Atrial Fibrillation with or without antiarrhythmic drugs
Measured: After one year of follow-up
Freedom from Atrial Tachycardia/Flutter with or without antiarrhythmic drugs
Number/Percentage of participants with freedom from Atrial Tachycardia/Flutter with or without antiarrhythmic drugs
Measured: After one year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Dec 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Responsible party
- Principal investigator, David Filgueiras-Rama, Hospital San Carlos, Madrid
- Investigators
- David Filgueiras-Rama, MD, PhD, Principal investigator, Hospital Clínico San Carlos & CNIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169320
- Sponsor's protocol ID
- TAILOR-AF
- Acronym
- TAILOR-AF
- Status last verified
- Aug 2023
- First submitted
- 26 Nov 2021
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Quintanilla JG, Alfonso-Almazan JM, Perez-Castellano N, Pandit SV, Jalife J, Perez-Villacastin J, Filgueiras-Rama D. Instantaneous Amplitude and Frequency Modulations Detect the Footprint of Rotational Activity and Reveal Stable Driver Regions as Targets for Persistent Atrial Fibrillation Ablation. Circ Res. 2019 Aug 30;125(6):609-627. doi: 10.1161/CIRCRESAHA.119.314930. Epub 2019 Aug 1.
PubMed 31366278Rosa G, Quintanilla JG, Salgado R, Gonzalez-Ferrer JJ, Canadas-Godoy V, Perez-Villacastin J, Perez-Castellano N, Jalife J, Filgueiras-Rama D. Mapping Technologies for Catheter Ablation of Atrial Fibrillation Beyond Pulmonary Vein Isolation. Eur Cardiol. 2021 May 17;16:e21. doi: 10.15420/ecr.2020.39. eCollection 2021 Feb.
PubMed 34093742Quintanilla JG, Shpun S, Jalife J, Filgueiras-Rama D. Novel approaches to mechanism-based atrial fibrillation ablation. Cardiovasc Res. 2021 Jun 16;117(7):1662-1681. doi: 10.1093/cvr/cvab108.
PubMed 33744913
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-TAILORed Ablation of Atrial Fibrillation Drivers in Persistent Stages Based on Instantaneous Amplitude and Frequency Modulation Criteria (TAILOR-AF)
- ClinicalTrials.gov ID
- NCT05169320
- Acronym / sponsor ID
- TAILOR-AF / TAILOR-AF
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Dec 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.
Pulmonary vein isolation (PVI) is still considered the cornerstone of catheter ablation for patients with persistent atrial fibrillation (AF). However, ablation outcomes in patients with persistent AF are suboptimal with high recurrence rates after a single PVI procedure.
Recently, the investigators developed a new strategy, which enables precise identification of the driver regions allegedly responsible for the maintenance of persistent AF outside the pulmonary veins. This approach uses a conventional electroanatomical mapping system and novel single-signal algorithms based on automatic and accurate analysis of the instantaneous amplitude and frequency modulations displayed by atrial signals during AF (iAM and iFM, respectively) to locate the spatiotemporally stable regions that drive persistent AF (leading drivers).
This strategy also enables to identify highly complex substrates in which targeting leading driver regions with catheter-based ablation may not be feasible or could be potentially associated with a significantly higher risk of complications. In such patients, the iAM/iFM maps obtained in the index catheter mapping and ablation procedure will be used to guide an additional patient-specific, minimally invasive surgical ablation approach via thoracoscopy, aiming to completely but specifically target all leading driver regions.
The main objective of the TAILOR-AF study is to identify (via iAM/iFM maps), target and ablate AF leading drivers in patients with symptomatic persistent AF recurrences despite ≥2 previous PVI procedures. The methods include a percutaneous catheter mapping and ablation approach followed by a minimally invasive surgical approach via thoracoscopy, if necessary. As a secondary objective we will study the association of underlying blood biomarkers, atrial imaging and surface ECG parameters, with advanced remodeling stages requiring a surgical approach to target leading driver regions.
This is a single center study (Hospital Clínico San Carlos, Madrid, Spain) that will recruit 25 patients with symptomatic persistent AF episodes despite having been submitted to ≥2 PVI prior procedures. All patients will undergo subcutaneous implantable loop recorder (ILR) implantation to address AF burden 1 month before the ablation procedure and at least 1 year after the ablation procedure. The primary outcome of the study will be AF freedom after one year of follow-up off antiarrhythmic drugs.
Detailed description
The study is co-sponsored by the Fundación para la Investigación Biomédica del Hospital Clínico San Carlos (Madrid, Spain) and the Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.) (Madrid, Spain).
Dr. David Filgueiras-Rama (MD, PhD, affiliation: Hospital Clínico San Carlos) and Dr. Jorge G. Quintanilla (MScEng, PhD, affiliation: Centro Nacional de Investigaciones Cardiovasculares [CNIC]) are Co-Principal Investigators of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Device: Subcutaneous implantable loop recorder (ILR) implantation, Procedure: Mapping and catheter ablation, Procedure: Minimally invasive surgical ablation via thoracoscopyPatients with symptomatic persistent AF episodes after previous failure of ≥2 pulmonary vein isolation procedures |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients from the Cardiored1 program (including 4 hospitals in Madrid, Spain) with symptomatic persistent AF in spite of ≥2 PVI previous procedures.
Key inclusion criteria (6 listed)
- Patients with symptomatic persistent AF (defined as a sustained episode lasting ≥ 7 days) despite ≥2 previous PVI, with or without other atrial anatomical targets isolated in previous procedures (e.g. superior vena cava, coronary sinus or others).
- AF episodes refractory to ≥1 antiarrhythmic drug (flecainide, propofenone, amiodarone or droneradore) or adverse events related to antiarrhythmic drugs that do not allow long-term drug therapy.
- Age between 18-75 years old.
- Patients must be willing and able to comply with all peri-ablation and follow-up requirements.
- Signed informed consent.
Key exclusion criteria (10 listed)
- Patients with paroxysmal AF (defined as a sustained episode lasting < 7 days).
- Patients for whom cardioversion or sinus rhythm will never be attempted/pursued.
- Patients with AF secondary to an obvious reversible cause.
- Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor.
- Non-sustained AF during the mapping procedure.
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 |
|---|---|---|
| Subcutaneous implantable loop recorder (ILR) implantationAll patients will undergo subcutaneous implantable loop recorder (ILR) implantation to quantify AF burden 1 month before the ablation procedure and at least 1 year after the ablation procedure. | Device | Case group |
| Mapping and catheter ablationDriver regions will be identified during persistent AF using a conventional electroanatomical mapping system, multielectrode mapping catheters, and leading-driver maps generated by novel single-signal algorithms based on an automatic and accurate analysis of the instantaneous amplitude and frequency modulations displayed by atrial signals (iAM and iFM, respectively). Such maps enable the location of the spatiotemporally stable regions that drive persistent AF (leading drivers). Leading-driver regions that can be reasonably targeted/isolated with catheter ablation without high-risk of complications upon radiofrequency delivery will be targeted for ablation. | Procedure or surgery | Case group |
| Minimally invasive surgical ablation via thoracoscopyThis procedure will be performed only in those patients whose leading-driver maps in the previous mapping and catheter ablation procedure fulfill the following requirements: 1. Extensive atrial remodeling who will not likely get any benefit from catheter-based ablation due to too large atrial leading driver areas (≥10-15% of atrial surface), or 2. Leading drivers located at regions with high-risk of complications upon radiofrequency delivery (e.g. left and right atrial appendages, coronary sinus, in the vicinity [≤5 mm] of the cardiac specific conduction system). In such patients, the leading-driver regions not completely targeted or not targeted at all in the previous index mapping and catheter ablation procedure, will be specifically ablated/isolated by minimally invasive surgical ablation techniques via thoracoscopy. | Procedure or surgery | Case group |
Primary outcome
Freedom from Atrial Fibrillation without antiarrhythmic drugs
Time frame: After one year of follow-up
Number/Percentage of participants with freedom from Atrial Fibrillation without antiarrhythmic drugs
3 secondary outcomes
Acute termination of Atrial Fibrillation during the procedure/s
Time frame: During catheter ablation and/or minimally invasive thoracoscopic surgical procedures
Freedom from Atrial Fibrillation with or without antiarrhythmic drugs
Time frame: After one year of follow-up
Freedom from Atrial Tachycardia/Flutter with or without antiarrhythmic drugs
Time frame: After one year of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Background: PubMed 31366278Quintanilla JG, Alfonso-Almazan JM, Perez-Castellano N, Pandit SV, Jalife J, Perez-Villacastin J, Filgueiras-Rama D. Instantaneous Amplitude and Frequency Modulations Detect the Footprint of Rotational Activity and Reveal Stable Driver Regions as Targets for Persistent Atrial Fibrillation Ablation. Circ Res. 2019 Aug 30;125(6):609-627. doi: 10.1161/CIRCRESAHA.119.314930. Epub 2019 Aug 1.
- Background: PubMed 34093742Rosa G, Quintanilla JG, Salgado R, Gonzalez-Ferrer JJ, Canadas-Godoy V, Perez-Villacastin J, Perez-Castellano N, Jalife J, Filgueiras-Rama D. Mapping Technologies for Catheter Ablation of Atrial Fibrillation Beyond Pulmonary Vein Isolation. Eur Cardiol. 2021 May 17;16:e21. doi: 10.15420/ecr.2020.39. eCollection 2021 Feb.
- Background: PubMed 33744913Quintanilla JG, Shpun S, Jalife J, Filgueiras-Rama D. Novel approaches to mechanism-based atrial fibrillation ablation. Cardiovasc Res. 2021 Jun 16;117(7):1662-1681. doi: 10.1093/cvr/cvab108.
- Eur Cardiol. 2021 May 17;16:e21.Link provided by the sponsor.
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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.
David Filgueiras-Rama, MD, PhD principal investigator
Hospital Clínico San Carlos & CNIC
2 sites 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 Hospital San Carlos, Madrid at 2 sites 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 10 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 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact David Filgueiras-Rama, MD, PhD (+34 914 531 200 ext. 1510, dfilgueiras@cnic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Atrial Fibrillation without antiarrhythmic drugs (time frame: After one year of follow-up). 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 NCT05169320, which also lists 3 linked publications.
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 7 Aug 2023.