Cardiac ArrhythmiasDELETE AFNCT05005143
Improved Procedural Workflow For Catheter Ablation Of Paroxysmal AF With High Density Mapping System And Advanced Technology
An observational study of Cardiac Arrhythmias and Atrial Fibrillation, run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial summary
DELETE AF is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias, Atrial Fibrillation
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to Dec 2023
- 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: All consecutive patients, clinically indicated for paroxysmal AF ablation, will be enrolled after signing an informed consent form and an authorization to use and disclose health information.
Who may be able to join
- History of recurrent symptomatic paroxysmal AF (PAF) with ≥1 episode reported and documented within the 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 seconds in duration and terminate within 7 days.
- Patients with an indication to an ablation procedure with 3D high-density mapping system according to current international and local guidelines (and future revisions), existing IFU and per physician discretion
- Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center.
- Patients whose age is 18 years or above, and of legal age to give informed consent specific to state and national law.
Who cannot join
- Patients who have persistent or long-standing persistent AF (>1 AF episodes lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year)
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
- Patients who are unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
- Patients unavailable or not willing to complete follow up visits and examination for the duration of the study at the center.
- Life expectancy ≤ 12 months per physician judgment.
- Patients who have undergone a previous cardiac ablation within 90 days prior to enrollment;
Show all 12Show fewer
- Unrecovered/unresolved Adverse Events from any previous invasive procedure;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
- Left atrial size > 60 mm diameter on echocardiogram
- Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
- AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause.
- History of prior surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Improved Procedural Workflow For Catheter Ablation Of Paroxysmal AF With High Density Mapping System And Advanced Technology: DELETE AF Study
DELETE AF is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. During the 12 months follow-up period, clinical atrial fibrillation recurrence, occurrence of all kind of atrial arrhythmias and of all Adverse Events in the study population will be collected.
The purpose of this study is to demonstrate a low rate of clinical atrial arrhythmias recurrence with an improved procedural workflow for catheter ablation of paroxysmal AF, using the most advanced point-by-point RF ablation technology in a multicenter setting. The primary objective of the study is the rate of success at the medium-long term follow-up after PVI in a population of consecutive patients undergoing paroxysmal AF ablation. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.
Read the detailed description
Catheter ablation has been shown to be better than antiarrhythmic drug therapy in preventing clinical recurrences of atrial fibrillation (AF) and has emerged as an important therapeutic option for treating symptomatic drug-refractory, paroxysmal AF, with a Class I level A recommendation in ESC and ACC/AHA guidelines.
Improvements in ablation technologies and techniques to safely create more durable lesions and could improve the risk- benefit profile of this procedure. Recent advances in RF catheter design include models with real-time monitoring of catheter-to-tissue contact force. Evidence suggests improved clinical success in paroxysmal AF ablation with stable catheter-tissue contact. In addition, advances in diagnostic catheter manufacturing techniques have improved tissue contact and reduced interelectrode distances, allowing multipoint recording with high spatial resolution and improved signal fidelity. These algorithmic improvements have improved the signal-to-noise ratio and automated the validation of cardiac signals. Novel insights from this revolutionary ultra-high density (UHD) mapping with rapid acquisition of thousands of activation points deepened physiological and pathophysiological understanding of cardiac electrophysiology and arrhythmogenesis. This includes the cardiac conduction system itself and more importantly, due to the number of affected patients, the healthy and diseased working myocardium. In that sense HDM-based targeted ablation, in conjunction with pacing manoeuvres can be helpful to avoid excessive ablation. Moreover, HDM has also been found to allow greater precision in the identification of reconnection gaps in pulmonary veins, therefore, targeted ablation resulted in lower radiofrequency time for PVI. The technological advances present great opportunities for improving the electroanatomic characterization of low-voltage activity in tissue such as the PV antra, likely representing vulnerabilities in antral lesion sets, and ablation of these targets seems to improve freedom from AF
The primary objective of the study is the rate of success at the medium-long term follow-up after PVI in consecutive patients undergoing atrial fibrillation ablation. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.
Secondary objectives of the study are: evaluation of acute procedural success, correlation between acute success and medium- long-term success, evaluation of the proportion of patients who will be asymptomatic during follow-up, patient reported outcomes, rate of clinical atrial fibrillation recurrence during follow up, rate of occurrence of other arrhythmias during follow-up, association between occurrence of atrial arrhythmias and baseline patient's characteristics (clinical history and drug therapy) or procedural data (post-hoc voltage and activation maps analysis), estimation of costs associated with the use of health care resources, rate of the adverse events associated with the primary ablation procedure and overall procedure time.
- Conditions
- Cardiac Arrhythmias, Atrial Fibrillation
- Keywords
- Catheter ablation, Arrhythmias, Mapping system, Atrial fibrillation
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal AF ablation | Patients with standard indications to paroxysmal AF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of patients with clinical atrial arrhythmia recurrences
The primary outcome measure of this study is to estimate, after 12-months from the procedure, the number and the percentage of patients with documented clinical atrial arrhythmia recurrences. Arrhythmias in the definition are any AF, atrial flutter, or atrial tachycardia episode, continuous for >30 seconds, as recorded by any post-ablation ECG modality. Arrhythmia recurrences within the first 3 months (blanking period) are classified as early recurrences and will not be considered procedural failure
Measured: 12 months
Secondary outcomes (7)
Acute procedural success of AF ablation
This secondary outcome measures the percentage of acute procedural success. The acute success of the AF ablation is verified by: the completion of the necessary ablation application(s), the validation of ablation through appropriate technique(s) and, when applicable, the termination of the primary arrhythmia.
Measured: Within 30 minutes after ablation procedure
Baseline patient's characteristic (clinical history and drug therapy) for subjects undergoing catheter ablation
This secondary outcome measures the baseline patient's characteristics (clinical history and drug therapy) as potential predictors of primary arrhythmia recurrences, that will be evaluated at 12 months
Measured: 12 months
Procedural ablation parameters
This secondary outcome measures the radiofrequency delivery time, the total ablation time, the fluoroscopy time, acquisition time, number of points per map, cardiac area and volume acquired from the maps
Measured: Intraoperative
Rate of adverse events and complications during procedure and follow up
This secondary outcome measures the rate of the adverse events that occurs during the procedure and after 12 months
Measured: 12 months for adverse events during follow up and intraoperative for acute adverse events
Estimate costs related to the use of health care resources
This secondary outcome measures the resource consumption and the associated costs in term of ablation procedures, follow-up, management of complication and health care resources utilization
Measured: 12 months
Patient reported outcomes: EQ-5D-5L
This secondary outcome measures patient reported outcomes through specific symptom scale questionnaire: EQ-5D-5L score will be obtained as the sum of units on the questionnaire's scale
Measured: 12 months
Patient reported outcomes: EHRA Score of AF-related Symptoms
AF related symptoms and symptom burden will be measured through the Symptom Severity Questionnaire and EHRA Symptom Classification Score of AF-related Symptoms
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 posted13 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
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 Cardiac ArrhythmiasStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ignacio Garcia-Bolao, Principal investigator, Department of Cardiology and Cardiac Surgery, Clínica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005143
- Sponsor's protocol ID
- PI_2021/41
- Acronym
- DELETE AF
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Solimene F, Stabile G, Ramos P, Segreti L, Cauti FM, De Sanctis V, Maggio R, Ramos-Maqueda J, Mont L, Schillaci V, Malacrida M, Garcia-Bolao I. Improved procedural workflow for catheter ablation of paroxysmal AF with high-density mapping system and advanced technology: Rationale and study design of a multicenter international study. Clin Cardiol. 2022 Jun;45(6):597-604. doi: 10.1002/clc.23806. Epub 2022 Apr 21.
PubMed 35446440
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Procedural Workflow For Catheter Ablation Of Paroxysmal AF With High Density Mapping System And Advanced Technology: DELETE AF Study
- ClinicalTrials.gov ID
- NCT05005143
- Acronym / sponsor ID
- DELETE AF / PI_2021/41
- Conditions
- Cardiac Arrhythmias, Atrial Fibrillation
- Keywords
- Catheter ablation, Arrhythmias, Mapping system, Atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Aug 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.
DELETE AF is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. During the 12 months follow-up period, clinical atrial fibrillation recurrence, occurrence of all kind of atrial arrhythmias and of all Adverse Events in the study population will be collected.
The purpose of this study is to demonstrate a low rate of clinical atrial arrhythmias recurrence with an improved procedural workflow for catheter ablation of paroxysmal AF, using the most advanced point-by-point RF ablation technology in a multicenter setting. The primary objective of the study is the rate of success at the medium-long term follow-up after PVI in a population of consecutive patients undergoing paroxysmal AF ablation. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.
Detailed description
Catheter ablation has been shown to be better than antiarrhythmic drug therapy in preventing clinical recurrences of atrial fibrillation (AF) and has emerged as an important therapeutic option for treating symptomatic drug-refractory, paroxysmal AF, with a Class I level A recommendation in ESC and ACC/AHA guidelines.
Improvements in ablation technologies and techniques to safely create more durable lesions and could improve the risk- benefit profile of this procedure. Recent advances in RF catheter design include models with real-time monitoring of catheter-to-tissue contact force. Evidence suggests improved clinical success in paroxysmal AF ablation with stable catheter-tissue contact. In addition, advances in diagnostic catheter manufacturing techniques have improved tissue contact and reduced interelectrode distances, allowing multipoint recording with high spatial resolution and improved signal fidelity. These algorithmic improvements have improved the signal-to-noise ratio and automated the validation of cardiac signals. Novel insights from this revolutionary ultra-high density (UHD) mapping with rapid acquisition of thousands of activation points deepened physiological and pathophysiological understanding of cardiac electrophysiology and arrhythmogenesis. This includes the cardiac conduction system itself and more importantly, due to the number of affected patients, the healthy and diseased working myocardium. In that sense HDM-based targeted ablation, in conjunction with pacing manoeuvres can be helpful to avoid excessive ablation. Moreover, HDM has also been found to allow greater precision in the identification of reconnection gaps in pulmonary veins, therefore, targeted ablation resulted in lower radiofrequency time for PVI. The technological advances present great opportunities for improving the electroanatomic characterization of low-voltage activity in tissue such as the PV antra, likely representing vulnerabilities in antral lesion sets, and ablation of these targets seems to improve freedom from AF
The primary objective of the study is the rate of success at the medium-long term follow-up after PVI in consecutive patients undergoing atrial fibrillation ablation. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.
Secondary objectives of the study are: evaluation of acute procedural success, correlation between acute success and medium- long-term success, evaluation of the proportion of patients who will be asymptomatic during follow-up, patient reported outcomes, rate of clinical atrial fibrillation recurrence during follow up, rate of occurrence of other arrhythmias during follow-up, association between occurrence of atrial arrhythmias and baseline patient's characteristics (clinical history and drug therapy) or procedural data (post-hoc voltage and activation maps analysis), estimation of costs associated with the use of health care resources, rate of the adverse events associated with the primary ablation procedure and overall procedure time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal AF ablation | – | –Patients with standard indications to paroxysmal AF ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients, clinically indicated for paroxysmal AF ablation, will be enrolled after signing an informed consent form and an authorization to use and disclose health information.
Key inclusion criteria (4 listed)
- History of recurrent symptomatic paroxysmal AF (PAF) with ≥1 episode reported and documented within the 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 seconds in duration and terminate within 7 days.
- Patients with an indication to an ablation procedure with 3D high-density mapping system according to current international and local guidelines (and future revisions), existing IFU and per physician discretion
- Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center.
- Patients whose age is 18 years or above, and of legal age to give informed consent specific to state and national law.
Key exclusion criteria (12 listed)
- Patients who have persistent or long-standing persistent AF (>1 AF episodes lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year)
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
- Patients who are unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
- Patients unavailable or not willing to complete follow up visits and examination for the duration of the study at the center.
- Life expectancy ≤ 12 months per physician judgment.
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
Number and percentage of patients with clinical atrial arrhythmia recurrences
Time frame: 12 months
The primary outcome measure of this study is to estimate, after 12-months from the procedure, the number and the percentage of patients with documented clinical atrial arrhythmia recurrences. Arrhythmias in the definition are any AF, atrial flutter, or atrial tachycardia episode, continuous for >30 seconds, as recorded by any post-ablation ECG modality. Arrhythmia recurrences within the first 3 months (blanking period) are classified as early recurrences and will not be considered procedural failure
7 secondary outcomes
Acute procedural success of AF ablation
Time frame: Within 30 minutes after ablation procedure
Baseline patient's characteristic (clinical history and drug therapy) for subjects undergoing catheter ablation
Time frame: 12 months
Procedural ablation parameters
Time frame: Intraoperative
Rate of adverse events and complications during procedure and follow up
Time frame: 12 months for adverse events during follow up and intraoperative for acute adverse events
Estimate costs related to the use of health care resources
Time frame: 12 months
Patient reported outcomes: EQ-5D-5L
Time frame: 12 months
Patient reported outcomes: EHRA Score of AF-related Symptoms
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Derived from this study: PubMed 35446440Solimene F, Stabile G, Ramos P, Segreti L, Cauti FM, De Sanctis V, Maggio R, Ramos-Maqueda J, Mont L, Schillaci V, Malacrida M, Garcia-Bolao I. Improved procedural workflow for catheter ablation of paroxysmal AF with high-density mapping system and advanced technology: Rationale and study design of a multicenter international study. Clin Cardiol. 2022 Jun;45(6):597-604. doi: 10.1002/clc.23806. Epub 2022 Apr 21.
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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.
Ignacio Garcia-Bolao principal investigator
Department of Cardiology and Cardiac Surgery, Clínica Universidad de Navarra
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias and Atrial Fibrillation, run by Clinica Universidad de Navarra, Universidad de Navarra.
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 4 inclusion and 12 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 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Irene Canales Ruiz (+34948255400, ucicec@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of patients with clinical atrial arrhythmia recurrences (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 NCT05005143, 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 13 Aug 2021.