Efficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip

E

Ettore Sansavini Health Science Foundation

Status

Completed

Conditions

Atrial Flutter

Treatments

Procedure: Radiofrequency Ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT01262443
ESREFO01

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure.

Full description

No more available data

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Both sexes; age>18 yrs
  • ECG documentation of at least 2 episodes of common atrial flutter or evidence of ongoing atrial flutter.
  • No contraindications to transcatheter radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
  • Patients willing to accept the tests and to follow standard procedures
  • Patients who understand the nature of the procedure and who are willing to participate and to sign the informed consent before enrollment

Exclusion criteria

  • Atrial fibrillation
  • Any arrhythmia requiring antiarrhythmics in the 6 months post procedure
  • Intra atrial thrombosis
  • NYHA class IV
  • Unstable Angina or Acute Myocardial Infarction (AMI) in the last 3 month
  • Untreated Wolf Parkinson White syndrome
  • Contraindications to oral anticoagulation
  • Life expectancy < 12 month
  • Major surgery or interventional procedure already planned in the 6 month following ablation
  • Pregnancy or breast-feeding
  • Participation in another study

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Therapy Cool Flex catheter group
Experimental group
Description:
Therapy Cool Flex Catheter . No more available data
Treatment:
Procedure: Radiofrequency Ablation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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