SmartTouch Catheter for Left Anterior Line - SmarT Line Study

Persistent Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217657
• Other study ID #: MucM001-13
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2021
• Source: Klinikum der Universitaet Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Thermocool Smart Touch Catheter
Physician informed to contact force

Locations

Country	Name	City	State
Germany	Munich University Clinic, Campus Großhadern	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	6 months