Evaluation of Thermocool SF Catheter on the Common Cavo-tricuspid Isthmus Dependent Atrial Flutter Ablation

March 2, 2016 updated by: Hospital Universitario Central de Asturias

Comparative Study to Assess Safety and Efficacy of Catheters CelsiusTMDS® 8 mm, Thermocool® 3.5 mm of Irrigated Tip and Thermocool® SF in the Treatment of Cavo-tricuspid Isthmus Dependent Atrial Flutter

The purpose of this study is to determine whether the Thermocool SF ® system is at least as effective and safe as regular 8mm catheters and irrigated tip catheters in the treatment of cavo-tricuspid isthmus dependent atrial flutter.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The catheter of Biosense Webster Thermocool SF® is characterized by a porous, thin-walled tip allowing a uniform cooling of the catheter tip and so, achieving increased efficiency in cooling. This allows to reduce the flow of irrigation and power output while achieving similar tissue temperatures as the conventional irrigated catheters. There is evidence of greater efficiency of Thermocool SF® catheter in causing tissue damage, but there are no clinical studies on the specific treatment of common atrial flutter.

Investigators hypothesize that the Thermocool SF® system is at least as effective and safe in the treatment of cavo-tricuspid isthmus dependent atrial flutter as conventional and 8 mm irrigated tip catheters.

150 patients with common atrial flutter were randomized to 3 groups of 50 patients and each group underwent ablation catheter ablation with CelsiusTMDS® 8 mm, 3.5 mm irrigated tip Thermocool® or Thermocool® SF respectively. After the procedure, patients are being followed by clinical reviews, electrocardiograms at the 3rd, 6th and 12th months, 24h ECG-Holter examination at the first and 6th month and monthly phone consultation. Rate of recurrence and presence of other supraventricular arrhythmias are being recorded during follow-up.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Principado de Asturias
      • Oviedo, Principado de Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with symptomatic common atrial flutter.
  • Electrocardiographic documentation of common atrial flutter.

Exclusion Criteria:

  • Refusal to give consent.
  • Life expectancy less than 6 months.
  • Contraindication for ablation.
  • Previous cavo-tricuspid isthmus ablation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CelsiusTMDS® 8 mm catheter
50 patients underwent ablation with CelsiusTMDS® 8 mm catheter.
Device: CelsiusTMDS® 8 mm catheter
After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with CelsiusTMDS® 8 mm catheter, until complete isthmic block is achieved.
ACTIVE_COMPARATOR: Thermocool® 3.5 mm irrigated catheter
50 patients underwent ablation with Thermocool® 3.5 mm catheter of irrigated tip.
Device: Thermocool® 3.5 mm catheter of irrigated tip
After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with Thermocool® 3.5 mm catheter of irrigated tip, until complete isthmic block is achieved.
EXPERIMENTAL: Thermocool® SF catheter
50 patients underwent ablation with Thermocool® SF catheter.
Device: Thermocool® SF catheter
After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with Thermocool® SF catheter, until complete isthmic block is achieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to get cavo-tricuspid isthmus block
Time Frame: during the ablation.
during the ablation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of fluoroscopy.
Time Frame: during the ablation.
during the ablation.
Radio frequency application time.
Time Frame: during the ablation.
during the ablation.
Complications.
Time Frame: within the first 24 hours.
Defined as vascular complications, cardiac tamponade and outbursts by tissue boiling.
within the first 24 hours.
Recurrence of atrial flutter.
Time Frame: one year.
one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Central de Asturias

Collaborators

Johnson & Johnson

Investigators

  • Principal Investigator: José Manuel Rubín López, PhD, Hospital Universitario Central de Asturias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (ESTIMATE)

March 3, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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