Back to resultsSmartTouch Catheter for Left Anterior Line - SmarT Line Study
Primary Purpose
Persistent Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Thermocool Smart Touch Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Smart-Touch, Contact force
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Munich University Clinic, Campus Großhadern
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
operator informed to contact force
operator blinded to contact force
Arm Description
Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster)
Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster)
Outcomes
Primary Outcome Measures
Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02217657
Brief Title
SmartTouch Catheter for Left Anterior Line - SmarT Line 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LMU Klinikum
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Smart-Touch, Contact force
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
operator informed to contact force
Arm Type
Active Comparator
Arm Description
Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster)
Arm Title
operator blinded to contact force
Arm Type
Experimental
Arm Description
Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster)
Intervention Type
Device
Intervention Name(s)
Thermocool Smart Touch Catheter
Intervention Description
Physician informed to contact force
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Achievement of primary endpoint (bidirectional conduction block at an anterior line)
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Estner, MD
Organizational Affiliation
Munich University Clinic, Campus Großhadern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Munich University Clinic, Campus Großhadern
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30320138
Citation
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.
Results Reference
derived
Learn more about this trial
SmartTouch Catheter for Left Anterior Line - SmarT Line Study
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