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Atrial FlutterPhase 3CathenaNCT02088489

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

A Phase 3 study testing Atrial flutter irrigated catheter and Atrial flutter porous tip catheter in people with Atrial Flutter, run by Hospital Clinic of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with the same safety. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Flutter
What is being tested?
Atrial flutter irrigated catheter and Atrial flutter porous tip catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSpain
Study dates
Nov 2012to Mar 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clinic de Barcelona

    Barcelona, 08036

Other trials in Spain

About this study

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

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

Read the 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.

Conditions
Atrial Flutter
Being tested
Atrial flutter irrigated catheter, Atrial flutter porous tip catheter
Keywords
Atrial flutter, Thermocool catheter, Thermocool SF catheter
Medical subject headings
Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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

Study groups in NCT02088489
Study groupRoleWhat they receive
Atrial flutter, irrigated catheterActive comparatorPatients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter
Receives: Device: Atrial flutter irrigated catheter
Atrial flutter, porous tip catheterExperimentalPatients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® SF(Biosense Webster, Diamond Bar, CA) irrigated catheter
Receives: Device: Atrial flutter porous tip catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time needed to block cavo-tricuspidal isthmus

    Measured: During ablation procedure

Secondary outcomes (4)

  1. Radiofrequency time.

    Total radiofrequency time needed to achieve cavo-tricuspidus isthmus (CTI) block.

    Measured: During ablation procedure

  2. Fluoroscopy time.

    Total X-ray time needed to achieve CTI block.

    Measured: During ablation procedure.

  3. Complications during the procedure.

    Measured: During ablation procedure.

  4. Survival free from flutter

    Proportion of patients not presenting with an atrial flutter recurrence.

    Measured: Up to 12 months after procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2014 (estimated)
  2. Study startNov 2012
  3. Primary completionFeb 2015
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02088489
Sponsor's protocol ID
SF vs Tc
Acronym
Cathena
Status last verified
Aug 2017
First submitted
26 Feb 2014
Last updated
10 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 8447269

  • 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.

    PubMed 21453368

  • 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.

    PubMed 19709510

  • 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.

    PubMed 22494043

  • 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.

    PubMed 16879626

  • 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.

    PubMed 1394929

  • 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.

    PubMed 7722135

  • 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.

    PubMed 15172468

  • 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.

    PubMed 16421689

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atrial flutter irrigated catheter and Atrial flutter porous tip catheter in people with Atrial Flutter, run by Hospital Clinic of Barcelona at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time needed to block cavo-tricuspidal isthmus (time frame: During ablation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02088489, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.

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