Clinical trial NCT02217657: 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
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Smart-Touch
Contact force
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)
timeFrame: 30 minutes
Secondary outcomes:
measure: Achievement of primary endpoint (bidirectional conduction block at an anterior line)
timeFrame: 6 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Munich University Clinic, Campus Großhadern
state: Bavaria
Study officials:
affiliation: Munich University Clinic, Campus Großhadern
name: Heidi Estner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.