Overview

This trial is active, not recruiting.

Condition atrial flutter.
Treatments celsiustmds® 8 mm catheter, thermocool® 3.5 mm catheter of irrigated tip, thermocool® sf catheter
Phase phase 4
Sponsor Hospital Universitario Central de Asturias
Collaborator Johnson & Johnson
Start date January 2012
End date December 2015
Trial size 150 participants
Trial identifier NCT02698592, 38/2012

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
50 patients underwent ablation with CelsiusTMDS® 8 mm catheter.
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)
50 patients underwent ablation with Thermocool® 3.5 mm catheter of irrigated tip.
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)
50 patients underwent ablation with Thermocool® SF catheter.
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.

Primary Outcomes

Measure
Time to get cavo-tricuspid isthmus block
time frame: during the ablation.

Secondary Outcomes

Measure
Time of fluoroscopy.
time frame: during the ablation.
Radio frequency application time.
time frame: during the ablation.
Complications.
time frame: within the first 24 hours.
Recurrence of atrial flutter.
time frame: one year.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator José Manuel Rubín López, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Hospital Universitario Central de Asturias.