Atrial FibrillationPERSONALIZENCT02497248
Non-invasive Characterization of the Mechanisms of Atrial Fibrillation Maintenance
An observational study of Atrial Fibrillation, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
Currently available antiarrhythmic drugs for the treatment of atrial fibrillation (AF) have a limited efficacy and often cause long-term side effects. Pulmonary vein isolation is the therapy of choice in drug-refractory patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmonary vein ablation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Jun 2019
- 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: AF patients with different mechanisms of maintenance (i.e. paroxysmal, persistent, valvular) and clinical indication for AF ablation.
Who may be able to join
- Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication.
- Patients with persistent AF symptomatic and refractory to at least one antiarrhythmic medication.
- Patients with severe mitral stenosis (mitral valve area ≤1.5 cm2, stage D) and favorable valve morphology in the absence of left atrial thrombus or moderate-to-severe mitral regurgitation.
- Patients must be able and willing to provide written informed consent to participate in the study.
- Prior anticoagulation for> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi (in patients with paroxysmal AF).
Who cannot join
- Patients with inadequate anticoagulation levels.
- Patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure.
- Patients with moderate-to-severe mitral regurgitation.
- Patients with contraindications to systemic anticoagulation with heparin or coumadin.
- Prior atrial fibrillation ablation.
- Patients who are or may potentially be pregnant.
Show all 9Show fewer
- Contraindication for adenosine administration;
- Current enrollment in another investigational drug or device study.
- Pacemaker or Implantable Cardioverter Defibrillator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PERSONALIZE-AF: Non-invasive Characterization of the Mechanisms of Atrial Fibrillation
Currently available antiarrhythmic drugs for the treatment of atrial fibrillation (AF) have a limited efficacy and often cause long-term side effects. Pulmonary vein isolation is the therapy of choice in drug-refractory patients. Recent studies have shown that ablation have a greater efficacy in patients in whom AF is maintained hierarchically and after ablation of rotors. The non-invasive identification of specific mechanism of AF maintenance in each patient could allow the selection of the most appropriate treatment.
Read the detailed description
The MAIN GOAL of this project is to clinically validate the technology for the noninvasive identification of the mechanisms responsible for maintenance of AF by body surface electrical mapping. To achieve this goal, noninvasive mapping of the atrial activity will be correlated with simultaneous endocardial mapping (high density contact catheters) using advanced signal analyses techniques (Dominant frequency, phase and causality mapping, inverse solution problem). These analyses will be performed in patients with different mechanisms of maintenance of AF (e.g. paroxysmal, persistent, valvular) undergoing AF ablation for clinical indication. Both endocardial and body surface mapping results will be correlated with biomarkers levels, MRI scans and AF outcomes of AF ablation at 6 months and 1 year after the procedure.
Wide antrum circumferential pulmonary vein isolation with demonstration of bidirectional block will be performed using standard cooled-tip radiofrequency catheters. In patients with mitral stenosis, PBMV will be performed according to Inoue´s technique followed by wide antrum circumferential pulmonary vein isolation. In all patients, MRI/CT scans and fibrosis biomarkers will be obtained at baseline, 6 months and 1 year post ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary vein ablation
- Keywords
- Atrial Fibrillation, Pulmonary Vein Ablation, Mitral stenosis, Body surface mapping
- Medical subject headings
- Atrial Fibrillation, Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein ablationProcedure or surgery
Also called Mitral Valvuloplasty in patients with severe mitral stenosis
Simultaneous biatrial endocardial electroanatomical mapping by high-density basket catheter (64 pin) and customized body surface mapping (57 electrodes) followed by circumferential pulmonary vein ablation.
| Study group | Role | What they receive |
|---|---|---|
| - Patients with paroxysmal AF. | Patients with AF episodes that terminates spontaneously or with intervention in less than seven days with clinical indication of pulmonary vein ablation. Receives: Procedure: Pulmonary vein ablation | |
| - Patients with persistent AF. | Patients with AF episodes that fails to self-terminate within seven days or require pharmacologic or electrical cardioversion to restore sinus rhythm with clinical indication of pulmonary vein ablation.. Receives: Procedure: Pulmonary vein ablation | |
| - Patients with mitral stenosis. | - Patients with mitral stenosis and clinical indication for AF ablation undergoing percutaneous balloon mitral valvuloplasty (PBMV) with clinical indication of pulmonary vein ablation.. Receives: Procedure: Pulmonary vein ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation off antiarrhythmic medications in patients with either paroxysmal, persistent AF or valvular stenosis AF.
Measured: 12 months post-first ablation procedure
Secondary outcomes (8)
Freedom from atrial fibrillation on or off antiarrhythmic medication post-first ablation procedure and after redo procedures.
Measured: at 6 and 12 months
Freedom from atrial fibrillation and other atrial arrhythmias post-first ablation procedure and after redo procedures.
Measured: at 6 and 12 months
Incidence of peri-procedural complications
Measured: during ablation procedure and 12 months after
Procedure duration
Measured: Duration of ablation procedure, and valvuloplasty if indicated, in minutes
Body surface recording analysis by 120 disposable electrodes distributed over the patient's chest and connected to the polygraph.
Measured: During ablation procedure, and valvuloplasty if indicated
Electroanatomic reconstruction and recordings of electrical activity: a three-dimensional reconstruction of atrium and coronary sinus is obtained using high density catheters and an electroanatomic navigation system.
Measured: During ablation procedure, and valvuloplasty if indicated
Atrial fibrosis determination using late gadolinium enhancement-MRI
Measured: At 6 and 12 months
Fluoroscopy time
Measured: During ablation procedure, and valvuloplasty if indicated, in minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2019
- Study completionJun 2019
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València, Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Felipe Atienza, MD, Principal investigator, Red de Investigación Cardiovascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497248
- Sponsor's protocol ID
- PERSONALIZE-AF
- Acronym
- PERSONALIZE
- Status last verified
- Dec 2021
- First submitted
- 30 Jun 2015
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Atienza F, Almendral J, Ormaetxe JM, Moya A, Martinez-Alday JD, Hernandez-Madrid A, Castellanos E, Arribas F, Arias MA, Tercedor L, Peinado R, Arcocha MF, Ortiz M, Martinez-Alzamora N, Arenal A, Fernandez-Aviles F, Jalife J; RADAR-AF Investigators. Comparison of radiofrequency catheter ablation of drivers and circumferential pulmonary vein isolation in atrial fibrillation: a noninferiority randomized multicenter RADAR-AF trial. J Am Coll Cardiol. 2014 Dec 16;64(23):2455-67. doi: 10.1016/j.jacc.2014.09.053.
PubMed 25500229
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERSONALIZE-AF: Non-invasive Characterization of the Mechanisms of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02497248
- Acronym / sponsor ID
- PERSONALIZE / PERSONALIZE-AF
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Pulmonary Vein Ablation, Mitral stenosis, Body surface mapping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València, Instituto de Salud Carlos III
- Study start
- Feb 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 14 Jul 2015 (estimated)
- 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.
Currently available antiarrhythmic drugs for the treatment of atrial fibrillation (AF) have a limited efficacy and often cause long-term side effects. Pulmonary vein isolation is the therapy of choice in drug-refractory patients. Recent studies have shown that ablation have a greater efficacy in patients in whom AF is maintained hierarchically and after ablation of rotors. The non-invasive identification of specific mechanism of AF maintenance in each patient could allow the selection of the most appropriate treatment.
Detailed description
The MAIN GOAL of this project is to clinically validate the technology for the noninvasive identification of the mechanisms responsible for maintenance of AF by body surface electrical mapping. To achieve this goal, noninvasive mapping of the atrial activity will be correlated with simultaneous endocardial mapping (high density contact catheters) using advanced signal analyses techniques (Dominant frequency, phase and causality mapping, inverse solution problem). These analyses will be performed in patients with different mechanisms of maintenance of AF (e.g. paroxysmal, persistent, valvular) undergoing AF ablation for clinical indication. Both endocardial and body surface mapping results will be correlated with biomarkers levels, MRI scans and AF outcomes of AF ablation at 6 months and 1 year after the procedure.
Wide antrum circumferential pulmonary vein isolation with demonstration of bidirectional block will be performed using standard cooled-tip radiofrequency catheters. In patients with mitral stenosis, PBMV will be performed according to Inoue´s technique followed by wide antrum circumferential pulmonary vein isolation. In all patients, MRI/CT scans and fibrosis biomarkers will be obtained at baseline, 6 months and 1 year post ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| - Patients with paroxysmal AF. | – | Procedure: Pulmonary vein ablationPatients with AF episodes that terminates spontaneously or with intervention in less than seven days with clinical indication of pulmonary vein ablation. |
| - Patients with persistent AF. | – | Procedure: Pulmonary vein ablationPatients with AF episodes that fails to self-terminate within seven days or require pharmacologic or electrical cardioversion to restore sinus rhythm with clinical indication of pulmonary vein ablation.. |
| - Patients with mitral stenosis. | – | Procedure: Pulmonary vein ablation- Patients with mitral stenosis and clinical indication for AF ablation undergoing percutaneous balloon mitral valvuloplasty (PBMV) with clinical indication of pulmonary vein ablation.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AF patients with different mechanisms of maintenance (i.e. paroxysmal, persistent, valvular) and clinical indication for AF ablation.
Key inclusion criteria (5 listed)
- Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication.
- Patients with persistent AF symptomatic and refractory to at least one antiarrhythmic medication.
- Patients with severe mitral stenosis (mitral valve area ≤1.5 cm2, stage D) and favorable valve morphology in the absence of left atrial thrombus or moderate-to-severe mitral regurgitation.
- Patients must be able and willing to provide written informed consent to participate in the study.
- Prior anticoagulation for> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi (in patients with paroxysmal AF).
Key exclusion criteria (9 listed)
- Patients with inadequate anticoagulation levels.
- Patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure.
- Patients with moderate-to-severe mitral regurgitation.
- Patients with contraindications to systemic anticoagulation with heparin or coumadin.
- Prior atrial fibrillation ablation.
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 ablationAlso: Mitral Valvuloplasty in patients with severe mitral stenosisSimultaneous biatrial endocardial electroanatomical mapping by high-density basket catheter (64 pin) and customized body surface mapping (57 electrodes) followed by circumferential pulmonary vein ablation. | Procedure or surgery | - Patients with mitral stenosis., - Patients with paroxysmal AF., - Patients with persistent AF. |
Primary outcome
Freedom from atrial fibrillation off antiarrhythmic medications in patients with either paroxysmal, persistent AF or valvular stenosis AF.
Time frame: 12 months post-first ablation procedure
8 secondary outcomes
Freedom from atrial fibrillation on or off antiarrhythmic medication post-first ablation procedure and after redo procedures.
Time frame: at 6 and 12 months
Freedom from atrial fibrillation and other atrial arrhythmias post-first ablation procedure and after redo procedures.
Time frame: at 6 and 12 months
Incidence of peri-procedural complications
Time frame: during ablation procedure and 12 months after
Procedure duration
Time frame: Duration of ablation procedure, and valvuloplasty if indicated, in minutes
Body surface recording analysis by 120 disposable electrodes distributed over the patient's chest and connected to the polygraph.
Time frame: During ablation procedure, and valvuloplasty if indicated
Electroanatomic reconstruction and recordings of electrical activity: a three-dimensional reconstruction of atrium and coronary sinus is obtained using high density catheters and an electroanatomic navigation system.
Time frame: During ablation procedure, and valvuloplasty if indicated
Atrial fibrosis determination using late gadolinium enhancement-MRI
Time frame: At 6 and 12 months
Fluoroscopy time
Time frame: During ablation procedure, and valvuloplasty if indicated, in minutes
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 14 Dec 2021.
- Background: PubMed 25500229Atienza F, Almendral J, Ormaetxe JM, Moya A, Martinez-Alday JD, Hernandez-Madrid A, Castellanos E, Arribas F, Arias MA, Tercedor L, Peinado R, Arcocha MF, Ortiz M, Martinez-Alzamora N, Arenal A, Fernandez-Aviles F, Jalife J; RADAR-AF Investigators. Comparison of radiofrequency catheter ablation of drivers and circumferential pulmonary vein isolation in atrial fibrillation: a noninferiority randomized multicenter RADAR-AF trial. J Am Coll Cardiol. 2014 Dec 16;64(23):2455-67. doi: 10.1016/j.jacc.2014.09.053.
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Atrial Fibrillation (AF)
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.
Felipe Atienza, MD principal investigator
Red de Investigación Cardiovascular
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 Hospital General Universitario Gregorio Marañon 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 5 inclusion and 9 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 14 Dec 2021. 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?
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?
Freedom from atrial fibrillation off antiarrhythmic medications in patients with either paroxysmal, persistent AF or valvular stenosis AF. (time frame: 12 months post-first ablation procedure). 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 NCT02497248, 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 14 Dec 2021.