Assessment of Safety of Laser Balloon AblationSingleLaserNCT04165642
Single-Laser PVI: Single-encirclement Laserballoon Ablation for Pulmonary Veins Isolation
An observational study of Assessment of Safety of Laser Balloon Ablation and Assessment of Procedural Times of Laser Ballon Ablation, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
To assess the efficacy of laser balloon ablation of atrial fibrillation (AF) without verification of electrical isolation of pulmonary veins using implantable loop recorder. This is a prospective and single-center study. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Assessment of Safety of Laser Balloon Ablation, Assessment of Procedural Times of Laser Ballon Ablation
- What is being tested?
- Laser ballon ablation for Pulmonary vein isolation
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 5 Jul 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 to 85 years
- All sexes
- Adult, Older adult
Study population: All patients referred to the Department of Arrhythmology for the management of parosysmal or persistent AF will be considered for eligibility. A subject, who meets all of the inclusion criteria, and none of the exclusion criteria, is eligible to participate in this study. All subjects enrolled in the clinical study (including those withdrawn from the clinical study or lost to follow-up) will be accounted for and documented, assigning an identification code linked to their names, alternative identification or contact information. This log will be kept up to date throughout the clinical study by the principal investigator (PI) or his/her authorized designee. To ensure subject privacy and confidentiality of data this log must be maintained throughout the clinical study at the clinical site.
Who may be able to join
- To participate in this clinical subject, the subject must meet all of the following inclusion criteria:
- Age between 18 and 85 years
- Paroxysmal or persistent AF
- Patients AF who have indications for the first time ablation procedure according to the ESC / EHRA recommendations (European Society of Cardiology / European Heart Rhythm Association).
- Ability to provide written informed consent for study participation and be willing and able to comply with the study evaluations and follow up schedule
Who cannot join
- Subjects are not eligible for clinical study participation if they meet any of the following exclusion criteria:
- Previous AF ablation procedures
- Secondary AF due to other causes
- Hyperthyroidism
- Left ventricular ejection fraction <30%
- NYHA class IV
Show all 16Show fewer
- Left atrium area > 35 cm2
- Severe disease of cardiac valves
- Contraindication to anticoagulant therapy
- Presence of thrombus in the left atrium
- Myocardial infarction or unstable angina or recent coronary artery bypass (<6 months)
- Thoracic surgery for congenital, valvular or aortic disease
- History of cerebrovascular events
- Pregnancy
- Significant comorbidity, such as cancer, severe kidney failure requiring dialysis, severe obstructive pulmonary disease, cirrhosis, with a life expectancy of less than 2 years
- Contraindications are present as indicated in the "instructions for use" of the devices used
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy of laser balloon ablation of atrial fibrillation (AF) without verification of electrical isolation of pulmonary veins using implantable loop recorder.
This is a prospective and single-center study. A targeted number of 82 patients suffering from paroxysmal or persistent AF, indicated to undergo catheter ablation will be included. The study will consist of: i) patient enrolment, ii) treatment phase, and iii) 1-year follow-up phase. The duration of the study is expected to be 24 months, from first patient enrolment to last patient follow up.
Read the detailed description
This is a prospective and single-center study. A targeted number of 82 patients suffering from paroxysmal or persistent AF, indicated to undergo catheter ablation will be included. The study will consist of: i) patient enrolment, ii) treatment phase, and iii) 1-year follow-up phase. The duration of the study is expected to be 24 months, from first patient enrolment to last patient follow up.
In a recent meta-analysis including 1188 patients, free from arrhythmic recurrences at 12 months after a single ablative procedure with a laser balloon and without continuous monitoring with ILR was 74%1.
Assuming that the approach without post-ablative verification of pulmonary vein isolation and continuous monitoring with ILR can lead to a 60% success rate at 12 months, 80 patients are required to have an 80% probability to observe a level of 2-code significance of 0.05 in an exponential model with the log rank test. With an estimated loss of data (patients lost to follow-up, protocol deviations and incomplete data) of 5%, the total number of patients to be enrolled is 82.
Subject screening and enrolment will be carried out for approximately 12 months. The study will continue up to 12 months after last patient enrolment, dependent on the rate of enrolment and the regulatory timeline (as applicable).
- Conditions
- Assessment of Safety of Laser Balloon Ablation, Assessment of Procedural Times of Laser Ballon Ablation
- Being tested
- Laser ballon ablation for Pulmonary vein isolation
- Keywords
- laser ballon ablation, laser ballon, pulmonary vein isolation, atrial fibrillation, AF ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser ballon ablation for Pulmonary vein isolationOther
The patients indicated to AF ablation procedure will be treated with laser balloon ablation without verification of electrical isolation of pulmonary veins using implantable loop recorder and/or Holter monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate at 1 year
Free from AF, atrial tachycardia and flutter documented with ILR or Holter ECG monitorwithout antiarrhythmic drugs.
Measured: 12 months after ablation
Secondary outcomes (3)
Procedural and 1-year complications related to the ablation procedure.
Procedural and 1-year complications related to the ablation procedure.
Measured: during the procedure and 12 months after ablation
inducibility of AF after the procedures
programmed atrial stimulation before and after isoproterenol
Measured: During the procedure
AF Burden
Assessment of AF burden by holter monitoring or implantable loop recorder
Measured: 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Oct 2019
- Primary completion22 Jun 2023
- Study completion5 Jul 2023
Why it stopped: due to unattainability of the expected sampling unit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Safety of Laser Balloon AblationStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Pappone, IRCCS Policlinico S. Donato
- Investigators
- Carlo Pappone, MD, PhD, Principal investigator, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165642
- Sponsor's protocol ID
- Paroxysmal or persistent AF
- Acronym
- SingleLaser
- Status last verified
- Sep 2023
- First submitted
- 13 Nov 2019
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Laser PVI: Single-encirclement Laserballoon Ablation for Pulmonary Veins Isolation
- ClinicalTrials.gov ID
- NCT04165642
- Acronym / sponsor ID
- SingleLaser / Paroxysmal or persistent AF
- Conditions
- Assessment of Safety of Laser Balloon Ablation, Assessment of Procedural Times of Laser Ballon Ablation
- Keywords
- laser ballon ablation, laser ballon, pulmonary vein isolation, atrial fibrillation, AF ablation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to unattainability of the expected sampling unit.
- Enrolment
- 82 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 18 Nov 2019 (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.
To assess the efficacy of laser balloon ablation of atrial fibrillation (AF) without verification of electrical isolation of pulmonary veins using implantable loop recorder.
This is a prospective and single-center study. A targeted number of 82 patients suffering from paroxysmal or persistent AF, indicated to undergo catheter ablation will be included. The study will consist of: i) patient enrolment, ii) treatment phase, and iii) 1-year follow-up phase. The duration of the study is expected to be 24 months, from first patient enrolment to last patient follow up.
Detailed description
This is a prospective and single-center study. A targeted number of 82 patients suffering from paroxysmal or persistent AF, indicated to undergo catheter ablation will be included. The study will consist of: i) patient enrolment, ii) treatment phase, and iii) 1-year follow-up phase. The duration of the study is expected to be 24 months, from first patient enrolment to last patient follow up.
In a recent meta-analysis including 1188 patients, free from arrhythmic recurrences at 12 months after a single ablative procedure with a laser balloon and without continuous monitoring with ILR was 74%1.
Assuming that the approach without post-ablative verification of pulmonary vein isolation and continuous monitoring with ILR can lead to a 60% success rate at 12 months, 80 patients are required to have an 80% probability to observe a level of 2-code significance of 0.05 in an exponential model with the log rank test. With an estimated loss of data (patients lost to follow-up, protocol deviations and incomplete data) of 5%, the total number of patients to be enrolled is 82.
Subject screening and enrolment will be carried out for approximately 12 months. The study will continue up to 12 months after last patient enrolment, dependent on the rate of enrolment and the regulatory timeline (as applicable).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the Department of Arrhythmology for the management of parosysmal or persistent AF will be considered for eligibility. A subject, who meets all of the inclusion criteria, and none of the exclusion criteria, is eligible to participate in this study. All subjects enrolled in the clinical study (including those withdrawn from the clinical study or lost to follow-up) will be accounted for and documented, assigning an identification code linked to their names, alternative identification or contact information. This log will be kept up to date throughout the clinical study by the principal investigator (PI) or his/her authorized designee. To ensure subject privacy and confidentiality of data this log must be maintained throughout the clinical study at the clinical site.
Key inclusion criteria (5 listed)
- To participate in this clinical subject, the subject must meet all of the following inclusion criteria:
- Age between 18 and 85 years
- Paroxysmal or persistent AF
- Patients AF who have indications for the first time ablation procedure according to the ESC / EHRA recommendations (European Society of Cardiology / European Heart Rhythm Association).
- Ability to provide written informed consent for study participation and be willing and able to comply with the study evaluations and follow up schedule
Key exclusion criteria (16 listed)
- Subjects are not eligible for clinical study participation if they meet any of the following exclusion criteria:
- Previous AF ablation procedures
- Secondary AF due to other causes
- Hyperthyroidism
- Left ventricular ejection fraction <30%
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 |
|---|---|---|
| Laser ballon ablation for Pulmonary vein isolationThe patients indicated to AF ablation procedure will be treated with laser balloon ablation without verification of electrical isolation of pulmonary veins using implantable loop recorder and/or Holter monitoring | Other | – |
Primary outcome
Success rate at 1 year
Time frame: 12 months after ablation
Free from AF, atrial tachycardia and flutter documented with ILR or Holter ECG monitorwithout antiarrhythmic drugs.
3 secondary outcomes
Procedural and 1-year complications related to the ablation procedure.
Time frame: during the procedure and 12 months after ablation
inducibility of AF after the procedures
Time frame: During the procedure
AF Burden
Time frame: 12 months after ablation
Results and safety
The study was stopped early (reason given: due to unattainability of the expected sampling unit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: Undecided
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.
Carlo Pappone, MD, PhD principal investigator
IRCCS Policlinico S. Donato
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 Assessment of Safety of Laser Balloon Ablation and Assessment of Procedural Times of Laser Ballon Ablation, run by IRCCS Policlinico S. Donato 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 16 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: stopped early, as of the sponsor's last update on 2 Oct 2023. 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?
The study was stopped early (reason given: due to unattainability of the expected sampling unit.). 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?
Success rate at 1 year (time frame: 12 months after ablation). 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 2 Oct 2023.