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

NCT01262443 | Completed DMC

• 1 other identifier: ESREFO01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Atrial Flutter

Keywords

Atrial flutter

Outcome Measures

Primary Outcomes (3)

• Percentual success of the procedure during the hospitalization

  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.

  Up to 4 days

• Percentual success of the procedure at 3 months from procedure

  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 months

• Percentual success of the procedure at 6 months from procedure

  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.

  6 months

Secondary Outcomes (3)

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

  Up to 4 days; 3-6 month

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

  Up to 4 days

• Safety of the procedure

  Up to 4 days

Study Arms (1)

Therapy Cool Flex catheter group

EXPERIMENTAL

Therapy Cool Flex Catheter . No more available data

Procedure: Radiofrequency Ablation

Interventions

Radiofrequency Ablation PROCEDURE

Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter

Therapy Cool Flex catheter group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ettore Sansavini Health Science Foundation: lead

Study Sites (2)

Maria Cecilia Hospital

Cotignola, RA, 48010, Italy

Location

Maria Pia Hospital

Torino, TO, 10132, Italy

Location

MeSH Terms

Conditions

Atrial Flutter

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Carlo Pappone, MD

  Maria Cecilia Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 17, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 3, 2016

Record last verified: 2014-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)