Atrial Flutter.Phase 4NCT02698592
Evaluation of Thermocool SF Catheter on the Common Cavo-tricuspid Isthmus Dependent Atrial Flutter Ablation
A Phase 4 study testing CelsiusTMDS® 8 mm catheter, Thermocool® 3.5 mm catheter of irrigated tip and Thermocool® SF catheter in people with Atrial Flutter., run by Hospital Universitario Central de Asturias at 1 site in Spain.
Trial 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. 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?
- CelsiusTMDS® 8 mm catheter, Thermocool® 3.5 mm catheter of irrigated tip and Thermocool® SF catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Dec 2016
- Phase
- Phase 4
- 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
- Patients with symptomatic common atrial flutter.
- Electrocardiographic documentation of common atrial flutter.
Who cannot join
- Refusal to give consent.
- Life expectancy less than 6 months.
- Contraindication for ablation.
- Previous cavo-tricuspid isthmus ablation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
About this study
Official title: Comparative Study to Assess Safety and Efficacy of Catheters CelsiusTMDS® 8 mm, Thermocool® 3.5 mm of Irrigated Tip and Thermocool® SF in the Treatment of Cavo-tricuspid Isthmus Dependent Atrial Flutter
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.
Read the detailed description
The catheter of Biosense Webster Thermocool SF® is characterized by a porous, thin-walled tip allowing a uniform cooling of the catheter tip and so, achieving increased efficiency in cooling. This allows to reduce the flow of irrigation and power output while achieving similar tissue temperatures as the conventional irrigated catheters. There is evidence of greater efficiency of Thermocool SF® catheter in causing tissue damage, but there are no clinical studies on the specific treatment of common atrial flutter.
Investigators hypothesize that the Thermocool SF® system is at least as effective and safe in the treatment of cavo-tricuspid isthmus dependent atrial flutter as conventional and 8 mm irrigated tip catheters.
150 patients with common atrial flutter were randomized to 3 groups of 50 patients and each group underwent ablation catheter ablation with CelsiusTMDS® 8 mm, 3.5 mm irrigated tip Thermocool® or Thermocool® SF respectively. After the procedure, patients are being followed by clinical reviews, electrocardiograms at the 3rd, 6th and 12th months, 24h ECG-Holter examination at the first and 6th month and monthly phone consultation. Rate of recurrence and presence of other supraventricular arrhythmias are being recorded during follow-up.
- Conditions
- Atrial Flutter.
- Being tested
- CelsiusTMDS® 8 mm catheter, Thermocool® 3.5 mm catheter of irrigated tip, Thermocool® SF catheter
- Keywords
- atrial flutter, ablation, 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.
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.
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® 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.
| Study group | Role | What they receive |
|---|---|---|
| CelsiusTMDS® 8 mm catheter | Active comparator | 50 patients underwent ablation with CelsiusTMDS® 8 mm catheter. Receives: 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. Receives: Device: Thermocool® 3.5 mm catheter of irrigated tip |
| Thermocool® SF catheter | Experimental | 50 patients underwent ablation with Thermocool® SF catheter. Receives: Device: Thermocool® SF catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to get cavo-tricuspid isthmus block
Measured: during the ablation.
Secondary outcomes (4)
Time of fluoroscopy.
Measured: during the ablation.
Radio frequency application time.
Measured: during the ablation.
Complications.
Defined as vascular complications, cardiac tamponade and outbursts by tissue boiling.
Measured: within the first 24 hours.
Recurrence of atrial flutter.
Measured: one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial Flutter.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Central de Asturias
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- José Manuel Rubín López, PhD, Principal investigator, Hospital Universitario Central de Asturias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698592
- Sponsor's protocol ID
- 38/2012
- Status last verified
- Feb 2016
- First submitted
- 29 Feb 2016
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10449701Jais 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.
PubMed 10683351Schreieck 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.
PubMed 12435182Scavee 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.
PubMed 12687839
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study to Assess Safety and Efficacy of Catheters CelsiusTMDS® 8 mm, Thermocool® 3.5 mm of Irrigated Tip and Thermocool® SF in the Treatment of Cavo-tricuspid Isthmus Dependent Atrial Flutter
- ClinicalTrials.gov ID
- NCT02698592
- Acronym / sponsor ID
- 38/2012
- Conditions
- Atrial Flutter.
- Keywords
- atrial flutter, ablation, Thermocool SF catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital Universitario Central de AsturiasUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The catheter of Biosense Webster Thermocool SF® is characterized by a porous, thin-walled tip allowing a uniform cooling of the catheter tip and so, achieving increased efficiency in cooling. This allows to reduce the flow of irrigation and power output while achieving similar tissue temperatures as the conventional irrigated catheters. There is evidence of greater efficiency of Thermocool SF® catheter in causing tissue damage, but there are no clinical studies on the specific treatment of common atrial flutter.
Investigators hypothesize that the Thermocool SF® system is at least as effective and safe in the treatment of cavo-tricuspid isthmus dependent atrial flutter as conventional and 8 mm irrigated tip catheters.
150 patients with common atrial flutter were randomized to 3 groups of 50 patients and each group underwent ablation catheter ablation with CelsiusTMDS® 8 mm, 3.5 mm irrigated tip Thermocool® or Thermocool® SF respectively. After the procedure, patients are being followed by clinical reviews, electrocardiograms at the 3rd, 6th and 12th months, 24h ECG-Holter examination at the first and 6th month and monthly phone consultation. Rate of recurrence and presence of other supraventricular arrhythmias are being recorded during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CelsiusTMDS® 8 mm catheter | Active comparator | Device: CelsiusTMDS® 8 mm catheter50 patients underwent ablation with CelsiusTMDS® 8 mm catheter. |
| Thermocool® 3.5 mm irrigated catheter | Active comparator | Device: Thermocool® 3.5 mm catheter of irrigated tip50 patients underwent ablation with Thermocool® 3.5 mm catheter of irrigated tip. |
| Thermocool® SF catheter | Experimental | Device: Thermocool® SF catheter50 patients underwent ablation with Thermocool® SF catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with symptomatic common atrial flutter.
- Electrocardiographic documentation of common atrial flutter.
Key exclusion criteria (4 listed)
- Refusal to give consent.
- Life expectancy less than 6 months.
- Contraindication for ablation.
- Previous cavo-tricuspid isthmus ablation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelsiusTMDS® 8 mm catheterAfter 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. | Device | CelsiusTMDS® 8 mm catheter |
| Thermocool® 3.5 mm catheter of irrigated tipAfter 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. | Device | Thermocool® 3.5 mm irrigated catheter |
| Thermocool® SF catheterAfter 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. | Device | Thermocool® SF catheter |
Primary outcome
Time to get cavo-tricuspid isthmus block
Time frame: during the ablation.
4 secondary outcomes
Time of fluoroscopy.
Time frame: during the ablation.
Radio frequency application time.
Time frame: during the ablation.
Complications.
Time frame: within the first 24 hours.
Recurrence of atrial flutter.
Time frame: one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Background: PubMed 10449701Tsai 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.
- Background: PubMed 10683351Jais 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.
- Background: PubMed 12435182Schreieck 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.
- Background: PubMed 12687839Scavee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Manuel Rubín López, PhD principal investigator
Hospital Universitario Central de Asturias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CelsiusTMDS® 8 mm catheter, Thermocool® 3.5 mm catheter of irrigated tip and Thermocool® SF catheter in people with Atrial Flutter., run by Hospital Universitario Central de Asturias 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 2 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: status not confirmed, as of the sponsor's last update on 3 Mar 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 to get cavo-tricuspid isthmus block (time frame: during the ablation.). 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 NCT02698592, which also lists 4 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 3 Mar 2016.