Atrial FlutterNCT02355106
Prospective, Multicenter, Investigation of the Adagio Cryoablation System in Subjects With Atrial Flutter
A study testing PolarStart System in people with Atrial Flutter, run by Adagio Medical at 2 sites in 2 countries.
Trial summary
The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- PolarStart System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2015to 21 May 2019
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Two symptomatic episodes of typical AFl (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFl occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFl tachyarrhythmia, including atrial fibrillation (AF).
- At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG) within 6 months prior to enrollment.
- Subject has been diagnosed with symptomatic AFl
- Subject is at least 18 and ≤75 years of age.
- Subject is able and willing to give informed consent
Who cannot join
- Intra-cardiac thrombus has not been eliminated in subjects exposed to less than 4 weeks of therapeutic anticoagulation and a TEE (trans-esophageal echocardiogram) and/or CT did not conclusively rule out thrombus
- Subject developed persistent AF at least once in history (electrical or pharmacological cardioversion after 48h or episode duration >7 days).
- Subject had any previous left atrial ablation.
- Subject had any previous cardiac surgery, e.g. prosthetic valves, except in the case of an isolated coronary bypass surgery performed more than three months prior to the procedure.
- Subject has permanent pacemaker or defibrillator implant.
- Subject has 2° type II, 3° degree atrioventricular (AV) block or left/right bundle branch block pattern
Show all 30Show fewer
- Subject has unstable angina pectoris.
- Subject has history of previous myocardial infarction (MI) or percutaneous intervention during the last three months or planned in the next 3 months.
- Subject has symptomatic carotid stenosis.
- Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension or any other evidence of significant lung disease.
- Subject has any contraindication for oral anticoagulation.
- Subject has any history of previous transient ischemic attack (TIA) or stroke.
- Subject has known intra-cardiac thrombus formation.
- Subject has any significant congenital heart defect corrected or not (except for patent foramen ovale that is allowed).
- Subject has evidence of congestive heart failure (NYHA class II, III or IV) in sinus rhythm.
- Subject has hypertrophic cardiomyopathy.
- Subject has abnormal long or short QT interval, signs of Brugada syndrome, known inheriting ion channel disease on the family, arrhythmogenic right ventricular dysplasia.
- Subject has sarcoidosis.
- Subject has myxoma.
- Subject has thrombocytosis (platelet count > 600,000 / μl) or thrombocytopenia (platelet count <100,000 / μl).
- Subject has any untreated or uncontrolled hyperthyroidism or hypothyroidism.
- Subject has renal dysfunction with glomerular filtration rate < 60 ml/min/1.72m2.
- Subject has a reversible causes for AF like alcoholism.
- Subject is a pregnant woman or woman of childbearing potential not on adequate birth control: only woman with a highly effective method of contraception [oral contraception or intra-uterine device] (who must have a negative pregnancy test within 1 week of randomization) or sterile woman can be enrolled.
- Subject is a breastfeeding woman.
- Subject has an active systemic infection.
- Subject is unwilling or unable to comply fully with study procedures and follow-up due to any disease condition, which can raise doubt about compliance and influencing the study outcome especially any kind of cancer requiring ongoing in-hospital treatment, severe bleeding in history or a suspected pro-coagulant state.
- Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.
- Subject has a life expectancy of ≤ 1 year.
- Subject is participating in any other clinical study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective, Multicenter, Investigation of the Adagio PolarStar System in Subjects With Atrial Flutter
The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter.
- Conditions
- Atrial Flutter
- Being tested
- PolarStart System
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolarStart SystemDevice
Atrial flutter Ablation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Atrial flutter Ablation Receives: Device: PolarStart System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by the percentage of subjects experiencing cardiovascular specific adverse events (CSAE) within thirty 30 days of the ablation procedure.
Measured: 30 DAYS
Secondary outcomes (2)
Acute Success measured by Percentage of subjects with termination of AFl and complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus at the end of the ablation procedure.
Measured: 30 minutes
Outcome success
Percent of subjects with absence of AFl at 30 days (30 day ECG and as reported by subject or holter monitor)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion1 May 2019
- Study completion21 May 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 FlutterStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adagio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355106
- Sponsor's protocol ID
- CS-001
- Status last verified
- Dec 2017
- First submitted
- 27 Jan 2015
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9.
PubMed 34196991
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Investigation of the Adagio PolarStar System in Subjects With Atrial Flutter
- ClinicalTrials.gov ID
- NCT02355106
- Acronym / sponsor ID
- CS-001
- Conditions
- Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Adagio MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 4 Feb 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.
The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: PolarStart SystemAtrial flutter Ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Two symptomatic episodes of typical AFl (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFl occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFl tachyarrhythmia, including atrial fibrillation (AF).
- At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG) within 6 months prior to enrollment.
- Subject has been diagnosed with symptomatic AFl
- Subject is at least 18 and ≤75 years of age.
- Subject is able and willing to give informed consent
Key exclusion criteria (30 listed)
- Intra-cardiac thrombus has not been eliminated in subjects exposed to less than 4 weeks of therapeutic anticoagulation and a TEE (trans-esophageal echocardiogram) and/or CT did not conclusively rule out thrombus
- Subject developed persistent AF at least once in history (electrical or pharmacological cardioversion after 48h or episode duration >7 days).
- Subject had any previous left atrial ablation.
- Subject had any previous cardiac surgery, e.g. prosthetic valves, except in the case of an isolated coronary bypass surgery performed more than three months prior to the procedure.
- Subject has permanent pacemaker or defibrillator implant.
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 |
|---|---|---|
| PolarStart SystemAtrial flutter Ablation | Device | Treatment |
Primary outcome
Safety measured by the percentage of subjects experiencing cardiovascular specific adverse events (CSAE) within thirty 30 days of the ablation procedure.
Time frame: 30 DAYS
2 secondary outcomes
Acute Success measured by Percentage of subjects with termination of AFl and complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus at the end of the ablation procedure.
Time frame: 30 minutes
Outcome success
Time frame: 30 days
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 22 May 2019.
- Derived from this study: PubMed 34196991Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PolarStart System in people with Atrial Flutter, run by Adagio Medical at 2 sites in 2 countries.
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 30 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 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. 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?
Safety measured by the percentage of subjects experiencing cardiovascular specific adverse events (CSAE) within thirty 30 days of the ablation procedure. (time frame: 30 DAYS). 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 NCT02355106, 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 22 May 2019.