Atrial Fibrillation (AF)CryoLIDNCT05410379
Antral Lesions Characterization of a New Cryoballoon Ablation System in Terms of Local Impedance Drop
An observational study of Atrial Fibrillation (AF), run by Maria Cecilia Hospital at 1 site in Italy.
Trial summary
Atrial fibrillation (AF) is defined as a supraventricular tachyarrhythmia with uncoordinated atrial electrical activation and consequently ineffective atrial contraction. Electrocardiographic characteristics of AF include: irregularly irregular R-R intervals (when atrioventricular conduction is not impaired), absence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2021to 15 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
- Adult, Older adult
Study population: Subjects enrolled in the CryoLID study will be clinically indicated for a cryoablation procedure and meet the study inclusion/exclusion criteria
Who may be able to join
- Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use;
- Subjects who are willing and capable of providing informed consent;
- Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center.
- Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Who cannot join
- Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use;
- Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use;
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
- Known or pre-existing severe Pulmonary Vein Stenosis;
- Evidence of myxoma, LA ( left atrium) thrombus or intracardiac mural thrombus;
- Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG (Coronary artery bypass graft surgery ), PTCA ( Percutaneous transluminal coronary angioplasty), stent procedure) within 90 days prior to enrollment;
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- Implantable cardiac device procedures ,e.g. PM (pacemaker), ICD( implantable cardioverter defibrillators), CRT within 30 days prior to enrollment;
- Implanted Left Atrial Appendage Closure device prior to the index procedure;
- Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder;
- Subjects with severe valvular disease OR with a prosthetic - mechanical or biological
- heart valve (not including valve repair and annular rings);
- Presence of any pulmonary vein stents;
- Active systemic infection;
- Vena cava embolic protection filter devices and/ or known femoral thrombus;
- Any previous history of cryoglobulinemia;
- History of blood clotting or bleeding disease;
- Any prior history of documented cerebral infarct, TIA (transient ischemic attack) or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment;
- Subjects who are hemodynamically unstable or with structural heart disease;
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
- Life expectancy ≤ 1 year per investigator's opinion;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion);
- Unrecovered/unresolved Adverse Events from any previous invasive Procedure;
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation (AF) is defined as a supraventricular tachyarrhythmia with uncoordinated atrial electrical activation and consequently ineffective atrial contraction. Electrocardiographic characteristics of AF include: irregularly irregular R-R intervals (when atrioventricular conduction is not impaired), absence of distinct repeating P waves, and irregular atrial activations.
Different AF classifications have been proposed but, traditionally, four patterns of AF are distinguished, based on presentation, duration, and spontaneous termination of AF episodes. Paroxysmal AF, that terminates spontaneously or with intervention within 7 days of onset. Persistent AF that is continuously sustained beyond 7 days, including episodes terminated by cardioversion (drugs or electrical cardioversion) after >7 days. Long-standing persistent (continuous AF of >12 months' duration) when decided to adopt a rhythm control strategy. Permanent AF, that is accepted by the patient and physician, and no further attempts to restore/maintain sinus rhythm will be undertaken.
The purpose of this study is to perform assessments of local impedance before and after cryoablation performed with the new POLAR X cryoballoon, in order to characterize the quality of the lesion and possibly to associate it with the acute success and 12 months AF recurrence-free rate.
- Conditions
- Atrial Fibrillation (AF)
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
local impedance drop
The primary endpoint of the study is the local impedance drop, measured as the difference between local impedance recorded by the rhythmic HDx mapping system at baseline and after PVI (pulmonary vein isolation) . For the primary endpoint assessment, impedance data will be analyzed offline and grouped per 4 anatomical segments around each pulmonary vein (PV). Absolute values of local impedance measured at baseline and after PVI, as well as local impedance drops will be also compared according to lesion success and according to the value of conventional predictors of successful cryo-lesions (e.g. TTI ( time to isolation ) < 60 s).
Measured: 6 months
Secondary outcomes (1)
failure-free rate at 12 months
The endpoint is the recurrence of atrial tachycardia (AT) and AF after the blanking period (3 months), as measured by means of ECG and 24h-holter. It will be evaluated by the failure-free rate at 12 months post-index procedure in each cohort.
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 posted8 Jun 2022
- Study start15 Sep 2021
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410379
- Sponsor's protocol ID
- MCH 2021-01
- Acronym
- CryoLID
- Status last verified
- May 2023
- First submitted
- 1 Jun 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antral Lesions Characterization of a New Cryoballoon Ablation System in Terms of Local Impedance Drop
- ClinicalTrials.gov ID
- NCT05410379
- Acronym / sponsor ID
- CryoLID / MCH 2021-01
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 8 Jun 2022 (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.
Atrial fibrillation (AF) is defined as a supraventricular tachyarrhythmia with uncoordinated atrial electrical activation and consequently ineffective atrial contraction. Electrocardiographic characteristics of AF include: irregularly irregular R-R intervals (when atrioventricular conduction is not impaired), absence of distinct repeating P waves, and irregular atrial activations.
Different AF classifications have been proposed but, traditionally, four patterns of AF are distinguished, based on presentation, duration, and spontaneous termination of AF episodes. Paroxysmal AF, that terminates spontaneously or with intervention within 7 days of onset. Persistent AF that is continuously sustained beyond 7 days, including episodes terminated by cardioversion (drugs or electrical cardioversion) after >7 days. Long-standing persistent (continuous AF of >12 months' duration) when decided to adopt a rhythm control strategy. Permanent AF, that is accepted by the patient and physician, and no further attempts to restore/maintain sinus rhythm will be undertaken.
The purpose of this study is to perform assessments of local impedance before and after cryoablation performed with the new POLAR X cryoballoon, in order to characterize the quality of the lesion and possibly to associate it with the acute success and 12 months AF recurrence-free rate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects enrolled in the CryoLID study will be clinically indicated for a cryoablation procedure and meet the study inclusion/exclusion criteria
Key inclusion criteria (4 listed)
- Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use;
- Subjects who are willing and capable of providing informed consent;
- Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center.
- Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
Key exclusion criteria (23 listed)
- Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use;
- Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use;
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
- Known or pre-existing severe Pulmonary Vein Stenosis;
- Evidence of myxoma, LA ( left atrium) thrombus or intracardiac mural thrombus;
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
local impedance drop
Time frame: 6 months
The primary endpoint of the study is the local impedance drop, measured as the difference between local impedance recorded by the rhythmic HDx mapping system at baseline and after PVI (pulmonary vein isolation) . For the primary endpoint assessment, impedance data will be analyzed offline and grouped per 4 anatomical segments around each pulmonary vein (PV). Absolute values of local impedance measured at baseline and after PVI, as well as local impedance drops will be also compared according to lesion success and according to the value of conventional predictors of successful cryo-lesions (e.g. TTI ( time to isolation ) < 60 s).
1 secondary outcome
failure-free rate at 12 months
Time frame: 12 months.
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 7 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (AF), run by Maria Cecilia Hospital 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 4 inclusion and 23 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 7 Sep 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 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?
local impedance drop (time frame: 6 months). 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 7 Sep 2023.