Atrial FibrillationLOWE-AF-HDNCT04362683
High Power Short Duration Ablation for Paroxysmal AF With High Density Multi Directional Mapping (LOWE AF HD Study).
An observational study of Atrial Fibrillation, run by Gregorio Covino at 1 site in Italy.
Trial summary
The LOWE AF HD is a prospective, single-center, non-randomized study to assess safety, efficacy, acute and long-term outcome data of a specific ablation approach as treatment of paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 83 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2020to 31 Mar 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: Patients eligible for participation in the study have indication for ablation of paroxysmal AF and are eligible for PVI by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure.
Who may be able to join
- Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal AF
- 18 Years and older.
- Able and willing to provide written informed consent prior to any clinical investigation related procedure
- Able and willing to complete all required study procedures through 12 months
- Life expectancy less than 12 months
Who cannot join
- Persistent or long-standing persistent AF
- Presence of thrombus in left atrium and left atrium appendage
- MI, CABG or PCI within preceding 3 months
- Left atrial diameter > 5.0 cm
- LVEF < 35%
- NYHA class III or IV
- Previous atrial fibrillation ablation procedure with high density and high-power short duration approach
- Previous tricuspid or mitral valve repair surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale San Giovanni Bosco
Naples, 80100
Gregorio Covino, MD, +39 0812545350, elettroSGB@gmail.com
About this study
Official title: Loop Recorder Evaluation in Patients Treated With High Power Short Duration Ablation for Paroxysmal Atrial Fibrillation With High Density Multi Directional Mapping (LOWE AF HD Study)
The LOWE AF HD is a prospective, single-center, non-randomized study to assess safety, efficacy, acute and long-term outcome data of a specific ablation approach as treatment of paroxysmal atrial fibrillation.
Read the detailed description
Pulmonary vein isolation using radiofrequency (RF) ablation is acknowledged used treatment strategy for atrial fibrillation, many different approaches are recently implemented. The specific approach used in this study includes:
- Multi-directional high-density mapping
- High power - short duration settings
- Contact force sensing ablation catheter The aim of LOWE AF HD is to assess the acute safety and success rate of this approach and also the long-term outcome assessed by atrial recurrences arrythmias collected by an implantable loop recorder.
- Conditions
- Atrial Fibrillation
- Keywords
- AF, High Power - Short Duration Ablation, High Density Mapping
- Medical subject headings
- 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 |
|---|---|---|
| High Power Atrial Fibrillation Ablation | In our center, routine medical care for atrial fibrillation ablation includes: * Multidirectional high-density mapping * High power - short duration settings * Contact force sensing ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Procedural Success Rate
Acute procedural success defined as electrical isolation of all pulmonary veins, confirmed by the high-density voltage remap and loss of pace capture along ablation line after complete isolation.
Measured: 1 day
Rate of patients without Atrial Fibrillation recurrences
Freedom from Atrial Fibrillation (AF) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL), lasting longer than 30 second, assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR).
Measured: 12 months after 3-months blanking period
Secondary outcomes (8)
Adverse events rate
Procedural and post procedural safety assessed by reporting all adverse events in the first 30 days after ablation
Measured: 1 month
Ablation Procedure Time
Complete procedure time (minutes)
Measured: 1 day
Ablation Fluoroscopic Time
Fluoroscopic time recorded (minutes) during ablation procedure
Measured: 1 day
Number of radiofrequency applications
Number of radiofrequency applications reported for each patient during ablation procedure.
Measured: 1 day
Total radiofrequency ablation time
Total time (minutes) of radiofrequency applications in each patient during ablation procedure.
Measured: 1 day
First pass pulmonary vein isolation
Number of patients in which PV isolation is obtained at first attempt.
Measured: 1 day
Number of atrial fibrillation events
Number of AF events symptomatic and asymptomatic assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR).
Measured: 12 months
Atrial Fibrillation Burden
AF Burden (in minutes) recorded at 12 months (after 3-months blanking period) of follow-up by Implantable Loop Recorder.
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 posted27 Apr 2020
- Study start30 Apr 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gregorio Covino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gregorio Covino, Ospedale S. Giovanni Bosco
- Investigators
- Gregorio Covino, MD, Principal investigator, Ospedale San Giovanni Bosco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362683
- Sponsor's protocol ID
- SGB01
- Acronym
- LOWE-AF-HD
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loop Recorder Evaluation in Patients Treated With High Power Short Duration Ablation for Paroxysmal Atrial Fibrillation With High Density Multi Directional Mapping (LOWE AF HD Study)
- ClinicalTrials.gov ID
- NCT04362683
- Acronym / sponsor ID
- LOWE-AF-HD / SGB01
- Conditions
- Atrial Fibrillation
- Keywords
- AF, High Power - Short Duration Ablation, High Density Mapping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Gregorio CovinoUniversity, hospital or other
- Study start
- 30 Apr 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 27 Apr 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.
The LOWE AF HD is a prospective, single-center, non-randomized study to assess safety, efficacy, acute and long-term outcome data of a specific ablation approach as treatment of paroxysmal atrial fibrillation.
Detailed description
Pulmonary vein isolation using radiofrequency (RF) ablation is acknowledged used treatment strategy for atrial fibrillation, many different approaches are recently implemented. The specific approach used in this study includes:
- Multi-directional high-density mapping
- High power - short duration settings
- Contact force sensing ablation catheter The aim of LOWE AF HD is to assess the acute safety and success rate of this approach and also the long-term outcome assessed by atrial recurrences arrythmias collected by an implantable loop recorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Power Atrial Fibrillation Ablation | – | –In our center, routine medical care for atrial fibrillation ablation includes: * Multidirectional high-density mapping * High power - short duration settings * Contact force sensing ablation catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for participation in the study have indication for ablation of paroxysmal AF and are eligible for PVI by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure.
Key inclusion criteria (5 listed)
- Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal AF
- 18 Years and older.
- Able and willing to provide written informed consent prior to any clinical investigation related procedure
- Able and willing to complete all required study procedures through 12 months
- Life expectancy less than 12 months
Key exclusion criteria (8 listed)
- Persistent or long-standing persistent AF
- Presence of thrombus in left atrium and left atrium appendage
- MI, CABG or PCI within preceding 3 months
- Left atrial diameter > 5.0 cm
- LVEF < 35%
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
Acute Procedural Success Rate
Time frame: 1 day
Acute procedural success defined as electrical isolation of all pulmonary veins, confirmed by the high-density voltage remap and loss of pace capture along ablation line after complete isolation.
Rate of patients without Atrial Fibrillation recurrences
Time frame: 12 months after 3-months blanking period
Freedom from Atrial Fibrillation (AF) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL), lasting longer than 30 second, assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR).
8 secondary outcomes
Adverse events rate
Time frame: 1 month
Ablation Procedure Time
Time frame: 1 day
Ablation Fluoroscopic Time
Time frame: 1 day
Number of radiofrequency applications
Time frame: 1 day
Total radiofrequency ablation time
Time frame: 1 day
First pass pulmonary vein isolation
Time frame: 1 day
Number of atrial fibrillation events
Time frame: 12 months
Atrial Fibrillation Burden
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 27 Apr 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Gregorio Covino, MD principal investigator
Ospedale San Giovanni Bosco
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 Gregorio Covino at 1 site in Italy.
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 8 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 27 Apr 2020. 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 Italy. 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 Gregorio Covino, MD (+39 0812545350, elettroSGB@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Procedural Success Rate (time frame: 1 day). The study lists 2 primary outcomes in all. 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 27 Apr 2020.