Overview

This trial is active, not recruiting.

Condition atrial flutter
Treatments atrial flutter irrigated catheter, atrial flutter porous tip catheter
Phase phase 3
Sponsor Hospital Clinic of Barcelona
Start date November 2012
End date February 2015
Trial size 70 participants
Trial identifier NCT02088489, SF vs Tc

Summary

Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with the same safety.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter
atrial flutter irrigated catheter
A duodecapolar isthmic curve catheter will be introduced to demonstrate cavo-tricuspidal bidirectional block. We performed atrial flutter ablation with conventional irrigated Thermocool® (Biosense Webster, Diamond Bar, CA) catheter Continuous lesions from tricuspidal annulus to inferior vena cava will be realized and then complete isthmic block will be confirmed by bidirectional stimulation
(Experimental)
Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® SF(Biosense Webster, Diamond Bar, CA) irrigated catheter
atrial flutter porous tip catheter
A duodecapolar isthmic curve catheter will be introduced to demonstrate cavo-tricuspidal bidirectional block. We performed atrial flutter ablation with Porous tip Thermocool® SF(Biosense Webster, Diamond Bar, CA)irrigated catheter Continuous lesions from tricuspidal annulus to inferior vena cava will be realized and then complete isthmic block will be confirmed by bidirectional stimulation

Primary Outcomes

Measure
Time needed to block cavo-tricuspidal isthmus
time frame: During ablation procedure

Secondary Outcomes

Measure
Radiofrequency time.
time frame: During ablation procedure
Fluoroscopy time.
time frame: During ablation procedure.
Complications during the procedure.
time frame: During ablation procedure.
Survival free from flutter
time frame: Up to 12 months after procedure.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All patients undergone to cti-dependent atrial flutter ablation. Exclusion Criteria: - Left atrial flutter or atrial fibrillation - Femoral venous access not available. - Anticoagulation not therapeutic in patients at high thrombo-embolic risk - Other contraindications to radiofrequency ablations: pregnancy, malignancy

Additional Information

Official title Effectiveness and Safety of Porous Tip Irrigated Ablation Catheter Versus Conventional Irrigated Catheter in Isthmus Dependent Atrial Flutter Ablation: a Randomized Study
Description New porous tip catheters appear more effective in atrial fibrillation ablation than conventional irrigated catheter, with the same safety. We could hypothesize porous tip irrigated catheters are more effective than conventional irrigated catheter, reducing procedure time and RF ablation time.We realize a randomized comparison study. For that, 70 patients with an indication for isthmus-dependent atrial flutter ablation will be randomized to conventional irrigated catheter ablation or porous tip irrigated catheter ablation. A ECG-Holter examination will be done at 1 month follow up after catheter ablation, 6 and 12 months.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hospital Clinic of Barcelona.