SmartTouch Catheter for Left Anterior Line - SmarT Line Study

Not Applicable

Completed

• Conditions: Persistent Atrial Fibrillation
• Interventions: Device: Thermocool Smart Touch Catheter

• Registration Number: NCT02217657
• Lead Sponsor: LMU Klinikum

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-15
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
operator blinded to contact force	Thermocool Smart Touch Catheter	Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster)
operator informed to contact force	Thermocool Smart Touch Catheter	Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster)

Primary Outcome Measures

Name	Time	Method
Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)	30 minutes

Secondary Outcome Measures

Name	Time	Method
Achievement of primary endpoint (bidirectional conduction block at an anterior line)	6 months	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).

Trial Locations

Locations (1)

Munich University Clinic, Campus Großhadern; 🇩🇪 Munich, Bavaria, Germany