NCT02088489

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

February 26, 2014

Last Update Submit

August 9, 2017

Conditions

Atrial Flutter

Keywords

Atrial flutterThermocool catheterThermocool SF catheter

Outcome Measures

Primary Outcomes (1)

  • Time needed to block cavo-tricuspidal isthmus

    During ablation procedure

Secondary Outcomes (4)

  • Radiofrequency time.

    During ablation procedure

  • Fluoroscopy time.

    During ablation procedure.

  • Complications during the procedure.

    During ablation procedure.

  • Survival free from flutter

    Up to 12 months after procedure.

Study Arms (2)

Atrial flutter, irrigated catheter

ACTIVE COMPARATOR

Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter

Device: Atrial flutter irrigated catheter

Atrial flutter, porous tip catheter

EXPERIMENTAL

Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® SF(Biosense Webster, Diamond Bar, CA) irrigated catheter

Device: Atrial flutter porous tip catheter

Interventions

Atrial flutter irrigated catheterDEVICE

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, irrigated catheter
Atrial flutter porous tip catheterDEVICE

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

Atrial flutter, porous tip catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergone to cti-dependent atrial flutter ablation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (9)

  • Cosio FG, Lopez-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. doi: 10.1016/0002-9149(93)91014-9.

    PMID: 8447269BACKGROUND

  • Ilg KJ, Kuhne 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.

    PMID: 21453368BACKGROUND

  • 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. doi: 10.1016/s1885-5857(09)72355-2. English, Spanish.

    PMID: 19709510BACKGROUND

  • 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.

    PMID: 22494043BACKGROUND

  • 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. doi: 10.1111/j.1540-8167.2006.00558.x. Epub 2006 Jul 18.

    PMID: 16879626BACKGROUND

  • 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. doi: 10.1161/01.cir.86.4.1233.

    PMID: 1394929BACKGROUND

  • 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. doi: 10.1016/0735-1097(95)00029-4.

    PMID: 7722135BACKGROUND

  • Scavee C, Jais P, Hsu LF, Sanders P, Hocini M, Weerasooriya R, Macle L, Raybaud F, Clementy J, Haissaguerre 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. doi: 10.1016/j.ehj.2004.03.017.

    PMID: 15172468BACKGROUND

  • 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. doi: 10.1007/s10840-006-5635-1. Epub 2006 Jan 18.

    PMID: 16421689BACKGROUND

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lluis Mont, MD, PhD

    Hospital Clinic of Barcelona

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Arrhythmia Unit

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 17, 2014

Study Start

November 1, 2012

Primary Completion

February 1, 2015

Study Completion

March 1, 2017

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations

ES(1)