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Completed

NCT Number: NCT01262443

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

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.

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria Cecilia Hospital, Cotignola, RA, Italy

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About this study

No more available data

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation

Procedure

Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter

Primary outcomes

  1. Percentual success of the procedure during the hospitalization

    Time frame: Up to 4 days

    Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.

  2. Percentual success of the procedure at 3 months from procedure

    Time frame: 3 months

    Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.

  3. Percentual success of the procedure at 6 months from procedure

    Time frame: 6 months

    Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.

Secondary outcomes

  1. •Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure.

    Time frame: Up to 4 days; 3-6 month

  2. Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given

    Time frame: Up to 4 days

  3. Safety of the procedure

    Time frame: Up to 4 days

    recording of procedure-related complications

Sponsors and collaborators

Lead sponsor

Ettore Sansavini Health Science Foundation

Other

Registry information

Official study title

Prospective Study to Evaluate the Acute and 6-month Efficacy of Transcatheter Radiofrequency Ablation of Common Atrial Flutter With a Standard Irrigated Catheter With Flexible Tip.

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2010
Registry last updated
Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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