CRioablation vs Antiarrhythmic Drugs for Persistent Atrial Fibrillation Trial (CRAFT)

CRioablation vs Antiarrhythmic Drugs for Persistent Atrial Fibrillation Trial (CRAFT) - CRAFT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004202-18-ES

Enrollment

196

Registered

2018-01-17

Start date

2018-01-30

Completion date

Unknown

Last updated

2023-09-26

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

Conditions

Recurrent Persistent Atrial Fibrillation MedDRA version: 20.0 Level: LLT Classification code 10071667 Term: Persistent atrial fibrillation System Organ Class: 100000004849

Interventions

Trade Name: Trangorex 200 mg comprimidos Pharmaceutical Form: Tablet INN or Proposed INN: AMIODARONE HYDROCHLORIDE CAS Number: 19774-82-4 Concentration unit: mg milligram(s) Concentration type: range

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with recurrent persistent 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 166 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: • Patients with AF for more than one year at baseline • FA prior ablation • Age> 75 years or 50 mm (left parasternal long axis) • Contraindications for anticoagulation • Left atrial thrombus • Anemia • Active infection • Pregnancy • FA secondary to transient, avoidable or correctable causes (hyperthyroidism, pneumonia, pulmonary embolism, drugs, hydroelectrolytic alterations ...) • Life expectancy of less than 24 months • Participation in another non-purely observational study • Patients unable to understand treatment and / or study and / or providing adequate informed consent • Any condition, that in the opinion of the physician responsible for the patient, contraindicates any of the treatments of the study

Design outcomes

Primary

Measure	Time frame
Main Objective: Patient survival at 9 month after intervention without atrial fibrilation (AF), auricular flutter either auricular tachicardia (AT) of more than 30 seconds duration,;Secondary Objective: • Number of episodes of AF, flutter or AT • Percentage of time in FA, flutter or AT • Need for cardioversion • Need for consultation in the emergency room • Need for ablation or re-ablation • Quality of life assessed by questionnaire (SF-36);Primary end point(s): Atrial fibrilation (AF) recurrence;Timepoint(s) of evaluation of this end point: 3, 6 and 12 month	—

Measure

Time frame

Main Objective: Patient survival at 9 month after intervention without atrial fibrilation (AF), auricular flutter either auricular tachicardia (AT) of more than 30 seconds duration,;Secondary Objective: • Number of episodes of AF, flutter or AT • Percentage of time in FA, flutter or AT • Need for cardioversion • Need for consultation in the emergency room • Need for ablation or re-ablation • Quality of life assessed by questionnaire (SF-36);Primary end point(s): Atrial fibrilation (AF) recurrence;Timepoint(s) of evaluation of this end point: 3, 6 and 12 month

—

Secondary

Measure	Time frame
Secondary end point(s): Time for first FA recurrence, number or AF episodes, need of cardioversion, need of emergency treatment, need of crioablation, Quality of life (SF-36), need of pharmacology threatment, drug use for, need of hospitalization, need of surgery, death.;Timepoint(s) of evaluation of this end point: 3, 6 and 12 month	—

Countries

Spain

Contacts

Public ContactFIC

Fundación Interhospitalaria para la Investigación Cardiovascular

info@fundacionfic.es+34915499728

Outcome results

None listed

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