NCT02698592

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

3.9 years

First QC Date

February 29, 2016

Last Update Submit

March 2, 2016

Conditions

Atrial Flutter.

Keywords

atrial flutterablationThermocool SF catheter

Outcome Measures

Primary Outcomes (1)

  • Time to get cavo-tricuspid isthmus block

    during the ablation.

Secondary Outcomes (4)

  • Time of fluoroscopy.

    during the ablation.

  • Radio frequency application time.

    during the ablation.

  • Complications.

    within the first 24 hours.

  • Recurrence of atrial flutter.

    one year.

Study Arms (3)

CelsiusTMDS® 8 mm catheter

ACTIVE COMPARATOR

50 patients underwent ablation with CelsiusTMDS® 8 mm catheter.

Device: CelsiusTMDS® 8 mm catheter

Thermocool® 3.5 mm irrigated catheter

ACTIVE COMPARATOR

50 patients underwent ablation with Thermocool® 3.5 mm catheter of irrigated tip.

Device: Thermocool® 3.5 mm catheter of irrigated tip

Thermocool® SF catheter

EXPERIMENTAL

50 patients underwent ablation with Thermocool® SF catheter.

Device: Thermocool® SF catheter

Interventions

CelsiusTMDS® 8 mm catheterDEVICE

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.

CelsiusTMDS® 8 mm catheter
Thermocool® 3.5 mm catheter of irrigated tipDEVICE

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.

Thermocool® 3.5 mm irrigated catheter
Thermocool® SF catheterDEVICE

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.

Thermocool® SF catheter

Eligibility Criteria

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

You may qualify if:

  • Patients with symptomatic common atrial flutter.
  • Electrocardiographic documentation of common atrial flutter.

You may not qualify if:

  • Refusal to give consent.
  • Life expectancy less than 6 months.
  • Contraindication for ablation.
  • Previous cavo-tricuspid isthmus ablation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Related Publications (4)

  • Tsai CF, Tai CT, Yu WC, Chen YJ, Hsieh MH, Chiang CE, Ding YA, Chang MS, Chen SA. Is 8-mm more effective than 4-mm tip electrode catheter for ablation of typical atrial flutter? Circulation. 1999 Aug 17;100(7):768-71. doi: 10.1161/01.cir.100.7.768.

    PMID: 10449701BACKGROUND

  • Jais P, Shah DC, Haissaguerre M, Hocini M, Garrigue S, Le Metayer P, Clementy J. Prospective randomized comparison of irrigated-tip versus conventional-tip catheters for ablation of common flutter. Circulation. 2000 Feb 22;101(7):772-6. doi: 10.1161/01.cir.101.7.772.

    PMID: 10683351BACKGROUND

  • Schreieck J, Zrenner B, Kumpmann J, Ndrepepa G, Schneider MA, Deisenhofer I, Schmitt C. Prospective randomized comparison of closed cooled-tip versus 8-mm-tip catheters for radiofrequency ablation of typical atrial flutter. J Cardiovasc Electrophysiol. 2002 Oct;13(10):980-5. doi: 10.1046/j.1540-8167.2002.00980.x.

    PMID: 12435182BACKGROUND

  • Scavee C, Georger F, Jamart J, Mancini I, Collet B, Blommaert D, De Roy L. Is a cooled tip catheter the solution for the ablation of the cavotricuspid isthmus? Pacing Clin Electrophysiol. 2003 Jan;26(1P2):328-31. doi: 10.1046/j.1460-9592.2003.00043.x.

    PMID: 12687839BACKGROUND

MeSH Terms

Conditions

Atrial Flutter

Interventions

Catheters

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • José Manuel Rubín López, PhD

    Hospital Universitario Central de Asturias

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 3, 2016

Study Start

January 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-02

Locations

ES(1)