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Completed

NCT Number: NCT02217657

SmartTouch Catheter for Left Anterior Line - SmarT Line Study

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.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Munich University Clinic, Campus Großhadern

Munich, Bavaria, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermocool Smart Touch Catheter

Device

Physician informed to contact force

Primary outcomes

  1. 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 outcomes

  1. Achievement of primary endpoint (bidirectional conduction block at an anterior line)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2014
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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