First-line catheter ablation for early treatment of Persistent (ongoing unless cardioverted) Atrial Fibrillation (AF) – a randomized study comparing isolation of pulmonary veins triggering AF using a Cryoballoon versus antiarrhythmic medication.

First-line cryoablation for early treatment of Persistent Atrial Fibrillation – a randomized study comparing early trigger isolation using the Cryoballoon versus antiarrhythmic medication. - CryoStopPersAF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006614-37-SE

Enrollment

220

Registered

2022-03-14

Start date

2022-05-11

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent symptomatic atrial fibrillation MedDRA version: 25.1 Level: LLT Classification code 10081865 Term: Cardiac catheter ablation System Organ Class: 100000004865

Interventions

Trade Name: tambocor Pharmaceutical Form: Tablet Trade Name: multaq Pharmaceutical Form: Tablet Trade Name: rytmonorm Pharmaceutical Form: Tablet Trade Name: sotalol Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Non-longstanding persistent symptomatic AF with at least 2 episodes within last 24 months (both shorter than 12 months in duration), the latest episode within the previous 6 months and, one should be documented on a 12 lead ECG or Holter monitor. a. Classical persistent AF as defined by ESC guidelines14, b. Persistent AF which has progressed from paroxysmal AF (patients who have been cardioverted within 7 days of onset provided a history of spontaneous conversion of episodes to sinus rhythm is lacking in near time) 2. Age 18 – 75 years, 3. Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. Regular daily use of antiarrhythmic drugs of class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta-blockers permitted). 2. Previous AF ablation or surgery. 3. Severe heart failure (NYHA III-IV). 4. Reduced left ventricular ejection fraction (LVEF 48. 6. Significant valvular disease requiring treatment or valve protesis. 7. Severe COPD stage III or chronic kidney disease (eGFR< 30 umol/l)). 8. Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months. 9. Myocardial infarction, revascularisation previous 6 months. 10. Stroke or TIA within previous 6 months. 11. Tachycardiomyopathy. 12. Dependent on VVI pacing. 13. Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs. 14. Expected survival less than 3 years, alcohol or drug abuse. 15. Participation in another trial or absence of consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main focus is to evaluate the impact of early interventional management of persistent AF. The primary goal is to evaluate if early pulmonary vein isolation performed with the Arctic Front cryoballoon as first-line therapy is superior to antiarrhythmic drugs (AAD) in preventing atrial arrhythmia recurrences. We hypothesized that first-line PVI using the cryoballon, at an early stage of the AF disease, will result in a 25 % reduction in any atrial tachyarrhythmia recurrence at 12 months compared to the AAD group ;Secondary Objective: The secondary goal is to evaluate the impact of early invasive intervention on health related quality of life (HRQOL) and symptoms, and on safety in comparison to primary AAD therapy, using generic and disease-specific HRQOL questionnaires and also assess Quality Adjusted Life Years (QALYs) score and EHRA classification of symptoms. The third goal is to assess the impact of an early intervention on cardiovascular health care use (hospitalisations and other health care utilization) and its relation to AF burden and to assess treatment burden and cost-effectiveness compared to AAD. ;Primary end point(s): The primary endpoint is freedom from atrial tachyarrhythmia recurrence lasting > 6 minutes (in the absence of aniarrhythmic drugs in ablation group) as documented by 12-lead ECG, ECG rhythm strip, Holter, or an implantable cardiac monitor, from initiation of treatment excluding the first 3 months (blanking period) to 12 months post after initiation of allocated treatment.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: The main focus is to evaluate the impact of early interventional management of persistent AF. The primary goal is to evaluate if early pulmonary vein isolation performed with the Arctic Front cryoballoon as first-line therapy is superior to antiarrhythmic drugs (AAD) in preventing atrial arrhythmia recurrences. We hypothesized that first-line PVI using the cryoballon, at an early stage of the AF disease, will result in a 25 % reduction in any atrial tachyarrhythmia recurrence at 12 months compared to the AAD group ;Secondary Objective: The secondary goal is to evaluate the impact of early invasive intervention on health related quality of life (HRQOL) and symptoms, and on safety in comparison to primary AAD therapy, using generic and disease-specific HRQOL questionnaires and also assess Quality Adjusted Life Years (QALYs) score and EHRA classification of symptoms. The third goal is to assess the impact of an early intervention on cardiovascular health care use (hospitalisations and other health care utilization) and its relation to AF burden and to assess treatment burden and cost-effectiveness compared to AAD. ;Primary end point(s): The primary endpoint is freedom from atrial tachyarrhythmia recurrence lasting > 6 minutes (in the absence of aniarrhythmic drugs in ablation group) as documented by 12-lead ECG, ECG rhythm strip, Holter, or an implantable cardiac monitor, from initiation of treatment excluding the first 3 months (blanking period) to 12 months post after initiation of allocated treatment.;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): Compare the effect of the two first-line treatment strategies with respect to the following endpoints during the total study period of 36 months in patients with symptomatic non-longstanding persistent AF at 12, 24, and 36 months (if not otherwise specified). 1. Total atrial arrhythmia burden (% time in AF/AT) 2. AF progression and reversion as measured by combination of reduced number of AF progressions or increased number of AF reversions after 3 months blanking. Progression or transition to more severe AF forms such as longstanding persistent or permanent AF and AF regression as going in the opposite direction from persistent to paroxysmal to sinus rhythm at 12, 24 and 36 months. 3. Healthcare utilization for cardiovascular reasons (number of cardioversions, ablations, AAD initiations, cardiovascular hospitalizations, emergency department visits and unplanned outpatient visits after 3 months blanking) and its relation to AF burden. Cardiovascular means related to atrial fibrillation including any treatment or diagnostic procedure for AF/AT such as cardioversions, medication, further AF ablations after AF recurrence, or any adverse events related to AF or its treatment such as thromboembolic complications (acute stroke), heart failure, myocardial ischemic events; adverse events (eg. pacemaker implantation). 4. Health care costs will be assessed at 36 months. Quality-adjusted life years (QALYs) using the EQ-5D over 3 years will be estimated from serial utility measurements from the Swedish population valuation of the EuroQoL EQ-5D at randomization. Health care use and cost-effectiveness, including CV hospitalization, outpatient visits, treatment costs, with corrections for background variables regarding social economic status. The time spent on sick-leave, duration and cost for not being at work will be retrieved from the sickness insurance institution, by informed consent from the patient, if necessary. 5. Single and multiple procedure suc	—

Measure

Time frame

Secondary end point(s): Compare the effect of the two first-line treatment strategies with respect to the following endpoints during the total study period of 36 months in patients with symptomatic non-longstanding persistent AF at 12, 24, and 36 months (if not otherwise specified). 1. Total atrial arrhythmia burden (% time in AF/AT) 2. AF progression and reversion as measured by combination of reduced number of AF progressions or increased number of AF reversions after 3 months blanking. Progression or transition to more severe AF forms such as longstanding persistent or permanent AF and AF regression as going in the opposite direction from persistent to paroxysmal to sinus rhythm at 12, 24 and 36 months. 3. Healthcare utilization for cardiovascular reasons (number of cardioversions, ablations, AAD initiations, cardiovascular hospitalizations, emergency department visits and unplanned outpatient visits after 3 months blanking) and its relation to AF burden. Cardiovascular means related to atrial fibrillation including any treatment or diagnostic procedure for AF/AT such as cardioversions, medication, further AF ablations after AF recurrence, or any adverse events related to AF or its treatment such as thromboembolic complications (acute stroke), heart failure, myocardial ischemic events; adverse events (eg. pacemaker implantation). 4. Health care costs will be assessed at 36 months. Quality-adjusted life years (QALYs) using the EQ-5D over 3 years will be estimated from serial utility measurements from the Swedish population valuation of the EuroQoL EQ-5D at randomization. Health care use and cost-effectiveness, including CV hospitalization, outpatient visits, treatment costs, with corrections for background variables regarding social economic status. The time spent on sick-leave, duration and cost for not being at work will be retrieved from the sickness insurance institution, by informed consent from the patient, if necessary. 5. Single and multiple procedure suc

—

Countries

Sweden

Contacts

Public ContactDepartment of Medical Science

Uppsala and Örebro University Hospitals

carina.blomstrom-lundqvist@medsci.uu.se+46706780442

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026