Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation

Atrial Flutter Clinical Trial

— Cathena  

Official title:

Effectiveness and Safety of Porous Tip Irrigated Ablation Catheter Versus Conventional Irrigated Catheter in Isthmus Dependent Atrial Flutter Ablation: a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088489
• Other study ID #: SF vs Tc
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2014
• Last updated: August 9, 2017
• Start date: November 2012
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2017
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Cosio FG, López-Gil M, Goicolea A, Arribas F, Barroso JL. Radiofrequency ablation of the inferior vena cava-tricuspid valve isthmus in common atrial flutter. Am J Cardiol. 1993 Mar 15;71(8):705-9. — View Citation

Cuesta A, Mont L, Alvarenga N, Rogel U, Brugada J. Comparison of 8-mm-tip and irrigated-tip catheters in the ablation of isthmus-dependent atrial flutter: a prospective randomized trial. Rev Esp Cardiol. 2009 Jul;62(7):750-6. English, Spanish. — View Citation

Dixit S, Gerstenfeld EP, Callans DJ, Cooper JM, Lin D, Russo AM, Verdino RJ, Patel VV, Kimmel SE, Ratcliffe SJ, Hsia HH, Nayak HM, Zado E, Ren JF, Marchlinski FE. Comparison of cool tip versus 8-mm tip catheter in achieving electrical isolation of pulmonary veins for long-term control of atrial fibrillation: a prospective randomized pilot study. J Cardiovasc Electrophysiol. 2006 Oct;17(10):1074-9. Epub 2006 Jul 18. — View Citation

Feld GK, Fleck RP, Chen PS, Boyce K, Bahnson TD, Stein JB, Calisi CM, Ibarra M. Radiofrequency catheter ablation for the treatment of human type 1 atrial flutter. Identification of a critical zone in the reentrant circuit by endocardial mapping techniques. Circulation. 1992 Oct;86(4):1233-40. — View Citation

Fischer B, Haissaguerre M, Garrigues S, Poquet F, Gencel L, Clementy J, Marcus FI. Radiofrequency catheter ablation of common atrial flutter in 80 patients. J Am Coll Cardiol. 1995 May;25(6):1365-72. — View Citation

Ilg KJ, Kühne M, Crawford T, Chugh A, Jongnarangsin K, Good E, Pelosi F Jr, Bogun F, Morady F, Oral H. Randomized comparison of cavotricuspid isthmus ablation for atrial flutter using an open irrigation-tip versus a large-tip radiofrequency ablation catheter. J Cardiovasc Electrophysiol. 2011 Sep;22(9):1007-12. doi: 10.1111/j.1540-8167.2011.02045.x. Epub 2011 Mar 31. — View Citation

McGreevy KS, Hummel JP, Jiangang Z, Haines DE. Comparison of a saline irrigated cooled-tip catheter to large electrode catheters with single and multiple temperature sensors for creation of large radiofrequency lesions. J Interv Card Electrophysiol. 2005 Dec;14(3):139-45. Epub 2006 Jan 18. — View Citation

Scaglione M, Blandino A, Raimondo C, Caponi D, Di Donna P, Toso E, Ebrille E, Cesarani F, Ferrarese E, Gaita F. Impact of ablation catheter irrigation design on silent cerebral embolism after radiofrequency catheter ablation of atrial fibrillation: results from a pilot study. J Cardiovasc Electrophysiol. 2012 Aug;23(8):801-5. doi: 10.1111/j.1540-8167.2012.02298.x. Epub 2012 Apr 11. — View Citation

Scavée C, Jaïs P, Hsu LF, Sanders P, Hocini M, Weerasooriya R, Macle L, Raybaud F, Clementy J, Haïssaguerre M. Prospective randomised comparison of irrigated-tip and large-tip catheter ablation of cavotricuspid isthmus-dependent atrial flutter. Eur Heart J. 2004 Jun;25(11):963-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time needed to block cavo-tricuspidal isthmus		During ablation procedure
Secondary	Radiofrequency time.	Total radiofrequency time needed to achieve cavo-tricuspidus isthmus (CTI) block.	During ablation procedure
Secondary	Fluoroscopy time.	Total X-ray time needed to achieve CTI block.	During ablation procedure.
Secondary	Complications during the procedure.		During ablation procedure.
Secondary	Survival free from flutter	Proportion of patients not presenting with an atrial flutter recurrence.	Up to 12 months after procedure.