SmartTouch Catheter for Left Anterior Line - SmarT Line Study

February 23, 2021 updated by: Heidi Estner, LMU Klinikum

"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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Munich University Clinic, Campus Grosshadern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: operator informed to contact force
Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster)
Device: Thermocool Smart Touch Catheter
Physician informed to contact force
Experimental: operator blinded to contact force
Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster)
Device: Thermocool Smart Touch Catheter
Physician informed to contact force

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LMU Klinikum

Investigators

  • Principal Investigator: Heidi Estner, MD, Munich University Clinic, Campus Grosshadern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MucM001-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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