A randomised comparison of cardioversion and catheter cryoablation in patients with persistent atrial fibrillation

Randomised controlled trial of cryoablation versus cardioversion in persistent atrial fibrillation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38385178

Enrollment

150

Registered

2018-03-13

Start date

2018-02-01

Completion date

Unknown

Last updated

2023-07-04

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

Conditions

Atrial fibrillation Circulatory System Arrhythmia

Interventions

The study is a randomised comparison of cardioversion (DCCV) to catheter cryoablation in patients with persistent atrial fibrillation (AF). Prior to intervention participants will hav

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. First presentation of persistent atrial fibrillation 2. Suitable for cryo catheter ablation 3. EHRA (European Heart Rhythm Association) Class 2 or higher after optimal rate control

Exclusion criteria

Exclusion criteria: 1. Renal failure with creatinine > 200 µmol/L or on dialysis 2. Pregnancy: current or currently planning 3. Previous ablation for atrial fibrillation 4. Previous DC cardioversion 5. Current participation in another clinical trial 6. Sinus rhythm at screening

Design outcomes

Primary

Measure	Time frame
1. Time to event analysis of first recurrence of atrial arrhythmia measured 90 days after index procedure: documented arrhythmia recurrence (atrial fibrillation, flutter or tachycardia), >30 seconds on Holter at 3, 6 and 12 months, sustained arrhythmia on hand held ECGs 2. Safety endpoint: composite of death from any cause and serious adverse events during the study based on patient history and medical records Timepoint(s): Duration of the study	—

Measure

Time frame

1. Time to event analysis of first recurrence of atrial arrhythmia measured 90 days after index procedure: documented arrhythmia recurrence (atrial fibrillation, flutter or tachycardia), >30 seconds on Holter at 3, 6 and 12 months, sustained arrhythmia on hand held ECGs 2. Safety endpoint: composite of death from any cause and serious adverse events during the study based on patient history and medical records Timepoint(s): Duration of the study

—

Secondary

Measure	Time frame
1. Death from any cause, death from arrhythmia, first rehospitalisation for cardiovascular causes, total number of hospitalizations for cardiovascular causes during the study based on patient history and medical records 2. Time to recurrent atrial fibrillation (any time), time to symptomatic atrial fibrillation is measured using either 24 hour Holter monitor or hand-held ECGs 3. Quality of life is measured using the EQ-5D-5L and AFEQT questionnaires at baseline and 12 months	—

Measure

Time frame

1. Death from any cause, death from arrhythmia, first rehospitalisation for cardiovascular causes, total number of hospitalizations for cardiovascular causes during the study based on patient history and medical records 2. Time to recurrent atrial fibrillation (any time), time to symptomatic atrial fibrillation is measured using either 24 hour Holter monitor or hand-held ECGs 3. Quality of life is measured using the EQ-5D-5L and AFEQT questionnaires at baseline and 12 months

—

Countries

England, United Kingdom

Outcome results

None listed

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