Persistent Atrial FibrillationNCT02217657
SmartTouch Catheter for Left Anterior Line - SmarT Line Study
A study testing Thermocool Smart Touch Catheter in people with Persistent Atrial Fibrillation, run by LMU Klinikum at 1 site in Germany.
Trial summary
This prospective, randomized study will investigate, if information of the catheter force during ablation of a left anterior line does reduce total RF application time by prevention of ineffective lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Thermocool Smart Touch Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Dec 2016
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic atrial fibrillation and additional substrate modification or perimitral flutter
- Patients with persistent atrial fibrillation
- Patients with perimitral flutter
- Patients with recurrence after a circumferential PV isolation procedure
- Patients with paroxysmal atrial fibrillation and AF episodes lasting > 7 days
- Patients (>18 und <80 Jahre)
Who cannot join
- moderate to severe valvular heart disease,
- congenital heart disease
- reduced left ventricular function (ejection fraction <35%)
- any reversible cause for atrial fibrillation (e.g. hyperthyroidism)
- intracardiac thrombi documented by transesophageal echocardiography
- myocardial infarction within 3 months, cardiac surgery in the previous three months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Munich University Clinic, Campus Großhadern
Munich, Bavaria, 81377
About this study
Official title: "Bidirectional Conduction Block of Left Atrial Anterior Line in Patients With Left Atrial Ablation - Reduction of RF Applications Using the Thermocool SmartTouch Contact Force Sensing Catheter
This prospective, randomized study will investigate, if information of the catheter force during ablation of a left anterior line does reduce total RF application time by prevention of ineffective lesions.
Read the detailed description
Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial fibrillation (AF).
The three main techniques described for ablation of persistent AF include pulmonary vein (PV) isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions.
The ideal endpoint of linear lesions should be complete electrical block; however, this is technically challenging, time consuming, and potentially hazardous. The ST catheter combined with 3D mapping and navigation software, gives physicians a real-time, objective measure of tip-to-tissue contact force during the catheter ablation procedure and will allow physicians to more safely and effectively treat atrial fibrillation.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Thermocool Smart Touch Catheter
- Keywords
- Smart-Touch, Contact force
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermocool Smart Touch CatheterDevice
Physician informed to contact force
| Study group | Role | What they receive |
|---|---|---|
| operator informed to contact force | Active comparator | Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster) Receives: Device: Thermocool Smart Touch Catheter |
| operator blinded to contact force | Experimental | Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster) Receives: Device: Thermocool Smart Touch Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)
Measured: 30 minutes
Secondary outcomes (1)
Achievement of primary endpoint (bidirectional conduction block at an anterior line)
Achievement of primary endpoint (bidirectional conduction block at an anterior line). Procedure Duration. Reduction of local potential amplitude during SR or atrial fibrillation after 60 seconds of ablation. Freedom of any atrial tachyarrhythmia at 7 day holter 3 and 6 months after a single ablation procedure. Freedom of any symptoms of atrial arrhythmias 6 months after ablation (except during blanking period of 6 weeks). Confirmation of gap-freeness in MRI (3-6 months after ablation). Quality of Life (atrial fibrillation symptom checklist und major depression index) pre, 3 and 6 months after Ablation. Safety (bleeding, pericardial effusion, thrombembolic events).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Estner, LMU Klinikum
- Investigators
- Heidi Estner, MD, Principal investigator, Munich University Clinic, Campus Großhadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217657
- Sponsor's protocol ID
- MucM001-13
- Status last verified
- Feb 2021
- First submitted
- 14 Aug 2014
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fichtner S, Wakili R, Rizas K, Siebermair J, Sinner MF, Wiktor T, Lackermair K, Schuessler F, Olesch L, Rainer S, Kaab S, Curta A, Kramer H, Estner HL. Benefit of Contact Force Sensing Catheter Technology for Successful Left Atrial Anterior Line Formation: A Prospective Randomized Trial. Biomed Res Int. 2018 Sep 18;2018:9784259. doi: 10.1155/2018/9784259. eCollection 2018.
PubMed 30320138
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Bidirectional Conduction Block of Left Atrial Anterior Line in Patients With Left Atrial Ablation - Reduction of RF Applications Using the Thermocool SmartTouch Contact Force Sensing Catheter
- ClinicalTrials.gov ID
- NCT02217657
- Acronym / sponsor ID
- MucM001-13
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Smart-Touch, Contact force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Aug 2014 (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.
This prospective, randomized study will investigate, if information of the catheter force during ablation of a left anterior line does reduce total RF application time by prevention of ineffective lesions.
Detailed description
Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial fibrillation (AF).
The three main techniques described for ablation of persistent AF include pulmonary vein (PV) isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions.
The ideal endpoint of linear lesions should be complete electrical block; however, this is technically challenging, time consuming, and potentially hazardous. The ST catheter combined with 3D mapping and navigation software, gives physicians a real-time, objective measure of tip-to-tissue contact force during the catheter ablation procedure and will allow physicians to more safely and effectively treat atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| operator informed to contact force | Active comparator | Device: Thermocool Smart Touch CatheterThermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster) |
| operator blinded to contact force | Experimental | Device: Thermocool Smart Touch CatheterThermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with symptomatic atrial fibrillation and additional substrate modification or perimitral flutter
- Patients with persistent atrial fibrillation
- Patients with perimitral flutter
- Patients with recurrence after a circumferential PV isolation procedure
- Patients with paroxysmal atrial fibrillation and AF episodes lasting > 7 days
Key exclusion criteria (6 listed)
- moderate to severe valvular heart disease,
- congenital heart disease
- reduced left ventricular function (ejection fraction <35%)
- any reversible cause for atrial fibrillation (e.g. hyperthyroidism)
- intracardiac thrombi documented by transesophageal echocardiography
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 |
|---|---|---|
| Thermocool Smart Touch CatheterPhysician informed to contact force | Device | operator blinded to contact force, operator informed to contact force |
Primary outcome
Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)
Time frame: 30 minutes
1 secondary outcome
Achievement of primary endpoint (bidirectional conduction block at an anterior line)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 30320138Fichtner S, Wakili R, Rizas K, Siebermair J, Sinner MF, Wiktor T, Lackermair K, Schuessler F, Olesch L, Rainer S, Kaab S, Curta A, Kramer H, Estner HL. Benefit of Contact Force Sensing Catheter Technology for Successful Left Atrial Anterior Line Formation: A Prospective Randomized Trial. Biomed Res Int. 2018 Sep 18;2018:9784259. doi: 10.1155/2018/9784259. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Heidi Estner, MD principal investigator
Munich University Clinic, Campus Großhadern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermocool Smart Touch Catheter in people with Persistent Atrial Fibrillation, run by LMU Klinikum at 1 site in Germany.
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 6 inclusion and 6 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 25 Feb 2021. 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 Germany. 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.
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?
Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes) (time frame: 30 minutes). 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 NCT02217657, which also lists 1 linked publication.
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 25 Feb 2021.