N/A
Completed N=20
Investigation of Therapeutic Ablation Versus Cardioversion for AF
Persistent Atrial Fibrillation · Cardiac Arrhythmia
Source: ClinicalTrials.gov NCT03907982 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Recurrence of Persistent AF (of AF Episode Lasting > 7 Days). — 3; 6 Participants
Summary
The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with cryoablation for atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion without an ablation procedure. The objectives of the Pilot Study are to validate the key study logistics with a view to optimising methods to be used in the main study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence of Persistent AF (of AF Episode Lasting > 7 Days). |
3; 6 | — |
| SECONDARY Death |
0; 0 | — |
| SECONDARY Rates of Subject Hospital Re-admission |
0; 1 | — |
| SECONDARY Procedural Complications |
1; 0 | — |
| SECONDARY Bleeding Events |
1; 0 | — |
| SECONDARY Rates of Repeat Procedures |
4; 7 | — |
| SECONDARY Clinical Success of Procedure |
7; 6 | — |
| SECONDARY Change in Quality of Life Measures (Using Short Form-12 Survey) |
12.21; 14.15 | — |
| SECONDARY Change in Quality of Life Measures (AF-PROMS) |
-23; -2 | — |
Eligibility Criteria
Inclusion Criteria: Patients who meet the following inclusion criteria will be eligible for the study;
- Ability to give informed consent
- Age 18-80 years
- Persistent AF (atrial fibrillation lasting > 7days) of total continuous duration 35
Data sourced from ClinicalTrials.gov (NCT03907982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.