Trial · NCT05939076
First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation
NCT05939076, Phase 3, Not yet recruiting, Region Örebro County
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation. Trials, record NCT05939076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05939076
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation
- NCT number
- NCT05939076
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 220 participants, estimated
- Lead sponsor
- Region Örebro County
- Conditions
- Atrial Fibrillation, Persistent
- Interventions
- Pulmonary vein isolation, dronedarone - Multaq™ OR flecainide - Tambocor™ OR propafenone - Rytmonorm™ OR sotalol - Sotacor™
- First posted
- 2023-07-11
- Last updated
- 2023-07-11
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients free from first atrial tachyarrhythmia recurrence lasting 6 minutes or longer | 12 months after initiation of allocated treatment excluding the first 3 months blanking period | In the absence of antiarrhythmic drugs in ablation group as documented by an implantable cardiac monitor from initiation of treatment. |
| Secondary | Total atrial arrhythmia burden (percentage of time in AF/AT) | baseline,12, 24, 36 months after initiation of treatment excluding the 3 months blanking period | Measured from the continuous implantable cardiac monitor with a 6 minutes AF episode detection cut-off limit. |
| Secondary | AF progression and reversion | baseline,12, 24, 36 months follow-up excluding 3 months blanking period | Progression to longstanding persistent or permanent AF/AT and regression going in opposite direction from persistent to paroxysmal AF or to sinus rhythm. Measured as combination of reduced number of progressions or increased number of AF/AT regression . |
| Secondary | Generic Health Related Quality of life (HRQoL) | baseline, 12, 24, 36 months follow-up | Generic Medical Outcomes Study Short Form-36 (SF-36) quality of life questionnaire using 8 subscales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Scores from 0 to 100; lower scores poorer QoL. |
| Secondary | Symptoms | baseline, 12, 24, 36 months after initiation of treatment | European Heart Rhythm Association (EHRA) Symptom Classification assessing the severity of AF related symptoms |
| Secondary | AF specific Health Related Quality of Life | baseline, 12, 24, 36 months after initiation of treatment excluding the 3 months blanking period | Assessed by University of Toronto Atrial Fibrillation Severity Scale (AFSS); 19-item AF-specific scale; ratings AF including 4 categories; 1. AF burden (calculated from modified sum of frequency, duration and severity of episodes); Total AF Burden=AF frequency + AF duration + AF severity. Each of 3 measures contributes equally to Total AF Burden score, and varies from 1-10 to yield Total AF Burden scores ranging from 3-30 where higher scores indicate greater AF burden. 2. Global Well Being (visual analogue scale 1-10; worst - best possible life); 3. AF Symptom Score (sum of 7 items on specified symptoms); For each of 7 questions (answers vary from 0=I have not had this symptom in past 4 weeks to 5=A great deal), values determined and summed together to form a total score (0-35). This score assumes linearity of severity. 4. Health Care Utilization (number of cardioversions, ablations, emergency room visits, hospitalizations due to arrhythmia, and specialist appointments). |
| Secondary | Cognitive function | baseline,12, 24, 36 months after initiation of treatment | Trail Making Test (TMT) parts A and B. Patient is asked to draw lines from figures in consecutive orders n 1-2-3 etc (TMT A) and from figures to letters 1-A-2-B etc.(TMT B) Examiner starts timing both part A and B and counts errors made. The Time in seconds and Number of errors are counted for both A and B test. The rhythm and pulse at the time of the evaluation will be recorded but is not used as a measure other than a binary value for correlation with cognitive function. |
| Secondary | Rate of Healthcare utilizations for cardiovascular reasons | baseline,12, 24, 36 months after initiation of treatment excluding the 3 months blanking period | Number of cardioversions, ablations, drug initiations, cardiovascular hospitalizations, emergency department visits and unplanned outpatient visits and its relation to AF/AT burden. Cardiovascular means related to AF including any treatment or diagnostic procedure for AF/AT, i.e. cardioversions, medication, further AF ablations after AF/AT recurrence, or any adverse events related to AF/AT or its treatment (acute stroke), heart failure, myocardial ischemic events; adverse events (eg. pacemaker implantation). |
| Secondary | Cost-effectiveness analysis by EuroQol-5 Dimensions (EQ-5D) | 36 months | Quality-adjusted life years (QALYs) using EQ-5D; QALYs will then be incorporated with medical costs; cost/QALY to compare the treatments. i) EQ-5D descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 5 levels. Digits combined into a 5-digit number for patient's health state. ii) Visual analogue vertical line scale (EQ-VAS) with endpoints labelled 'The best and worst health you can imagine' as a quantitative measure of health outcome reflecting patient's own judgement. Cost-effectiveness analysis of the treatments examining costs and health outcomes of the two interventions. It compares the interventions by estimating how much it costs to gain a unit of a health outcome. |
| Secondary | Proportion of patients with Reverse atrial remodeling | baseline, 12, 24 and 36 months | Proportion of patients with Reverse atrial remodeling as defined by at least 15% decrease of Left atrial maximal volume index (ml/m2) or increase of left atrial strain during reservoir phase (percentage) or left atrial strain during contraction phase (percentage) versus baseline. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers40
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05939076
GET https://conductscience.org/api/trials/v1/NCT05939076/papers?page=2