Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation (Cathena)

• ClinicalTrials.gov Identifier: NCT02088489
• Recruitment Status: Completed
• First Posted: March 17, 2014
• Last Update Posted: August 10, 2017
• Sponsor: Hospital Clinic of Barcelona
• Information provided by (Responsible Party): Josep Lluis Mont Girbau, Hospital Clinic of Barcelona

Tracking Information

• First Submitted Date: February 26, 2014
• First Posted Date: March 17, 2014
• Last Update Posted Date: August 10, 2017
• Actual Study Start Date: November 2012
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 13, 2014): Time needed to block cavo-tricuspidal isthmus [ Time Frame: During ablation procedure ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 13, 2014)

• Radiofrequency time. [ Time Frame: During ablation procedure ]
  Total radiofrequency time needed to achieve cavo-tricuspidus isthmus (CTI) block.
• Fluoroscopy time. [ Time Frame: During ablation procedure. ]
  Total X-ray time needed to achieve CTI block.
• Complications during the procedure. [ Time Frame: During ablation procedure. ]
• Survival free from flutter [ Time Frame: Up to 12 months after procedure. ]
  Proportion of patients not presenting with an atrial flutter recurrence.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation
• Official Title: Effectiveness and Safety of Porous Tip Irrigated Ablation Catheter Versus Conventional Irrigated Catheter in Isthmus Dependent Atrial Flutter Ablation: a Randomized Study
• Brief Summary: Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with the same safety.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: 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
• Device: 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

Study Arms

• Active Comparator: Atrial flutter, irrigated catheter
  Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter
  Intervention: Device: Atrial flutter irrigated catheter
• Experimental: Atrial flutter, porous tip catheter
  Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® SF(Biosense Webster, Diamond Bar, CA) irrigated catheter
  Intervention: Device: Atrial flutter porous tip catheter

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 13, 2014): 70
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2017
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02088489
• Other Study ID Numbers: SF vs Tc
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
• Study Sponsor: Hospital Clinic of Barcelona
• Collaborators: Not Provided

Investigators

• Study Chair: Lluis Mont, MD, PhD; Hospital Clinic of Barcelona

• PRS Account: Hospital Clinic of Barcelona
• Verification Date: August 2017