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Clinical Trials/EUCTR2017-004202-18-ES
EUCTR2017-004202-18-ES
Active, not recruiting
Phase 1

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

Fundación Interhospitalaria para la Investigación Cardiovascular0 sites196 target enrollmentJanuary 17, 2018
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ConditionsRecurrent Persistent Atrial FibrillationMedDRA version: 20.0Level: LLTClassification code 10071667Term: Persistent atrial fibrillationSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsTrangorex 200 mg comprimidosDicorynan 100 mg cápsulas durasRytmonorm 150 mg comprimidos recubiertosFlecainida Normon 100 mg comprimidos EFGFlecard 100 comprimidos EFGFlecainida Apotex 100 mg comprimidos EFGMULTAQ 400 mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Recurrent Persistent Atrial Fibrillation
Sponsor
Fundación Interhospitalaria para la Investigación Cardiovascular
Enrollment
196
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 17, 2018
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundación Interhospitalaria para la Investigación Cardiovascular

Eligibility 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

  • •Patients with AF for more than one year at baseline
  • •FA prior ablation
  • •Age\> 75 years or \<18 years
  • •Hyperthyroidism
  • •Hypertrophic cardiomyopathy
  • •Severe valvular disease (stenosis or regurgitation)
  • •Carriers of cardiac valves
  • •AP Diameter of AI\> 50 mm (left parasternal long axis)
  • •Contraindications for anticoagulation
  • •Left atrial thrombus

Outcomes

Primary Outcomes

Not specified

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