Prospective Study to Evaluate the Efficacy of Transcatheter Ablation of Atrial Flutter With a Standard Irrigated Catheter With Flexible Tip. The FLEX STUDY

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier:
NCT01262443
First received: December 13, 2010
Last updated: May 18, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Atrial Flutter
Procedure: Radiofrequency Ablation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Further study details as provided by Ettore Sansavini Health Science Foundation:

Primary Outcome Measures:
  • Percentual success of the procedure during the hospitalization [ Time Frame: Up to 4 days ] [ Designated as safety issue: No ]
    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.

  • Percentual success of the procedure at 3 months from procedure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Percentual success of the procedure at 6 months from procedure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • •Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure. [ Time Frame: Up to 4 days; 3-6 month ] [ Designated as safety issue: No ]
  • Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given [ Time Frame: Up to 4 days ] [ Designated as safety issue: Yes ]
  • Safety of the procedure [ Time Frame: Up to 4 days ] [ Designated as safety issue: Yes ]
    recording of procedure-related complications


Enrollment: 30
Study Start Date: November 2010
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapy Cool Flex catheter group
Therapy Cool Flex Catheter
Procedure: Radiofrequency Ablation
Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262443

Locations
Italy
Maria Cecilia Hospital
Cotignola, RA, Italy, 48010
Maria Pia Hospital
Torino, TO, Italy, 10132
Sponsors and Collaborators
Ettore Sansavini Health Science Foundation
  More Information

No publications provided

Responsible Party: Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier: NCT01262443     History of Changes
Other Study ID Numbers: ESREFO01
Study First Received: December 13, 2010
Last Updated: May 18, 2014
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Ettore Sansavini Health Science Foundation:
Atrial flutter

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014