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Therapy of Atrial Flutter by Afib Ablation

NCT02051621 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-01-31

No results posted yet for this study

Summary

Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has a high success rate (5). It has been recognized that patients with typical atrial flutter often complain of atrial fibrillation (1,2). Current clinical and experimental studies confirm the close relationship between atrial flutter (AFL) and atrial fibrillation (AF) and raise a question, if both arrhythmias are different forms of a common electrical phenomenon with atrial fibrillation being the underlying clinical problem (6).

Conditions

Interventions

DRUG

Antiarrhythmic drug

medical treatment of atrial flutter with either flecainide (Tambocor ®) 100 mg twice daily, propafenone (Rytmonorm ®) up to 150 mg 3 times daily) or amiodarone (Cordarex®) 200 mg daily electrical cardioversion as needed

PROCEDURE

Cavo-tricuspid-isthmus-ablation

irrigated radiofrequency (RF)-ablation of the cavo-tricuspid-isthmus catheter used: Thermocool R (F-type), Biosense Webster, Diamond Bar, CA, USA

PROCEDURE

Pulmonary vein isolation

pulmonary vein angiography followed by antral pulmonary vein isolation using 3D-electroanatomical Mapping mapping system: Carto 3 (Biosense Webster, Diamond Bar, CA, USA) catheter used for irrigated RF-ablation: Navistar Thermocool R (D, E or F-type according to atrial dimensions), Biosense Webster, Diamond Bar, CA, USA

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Medtronic

    collaborator INDUSTRY

  • University of Rostock

    lead OTHER

Principal Investigators

  • Dietmar Baensch, PhD, MD · University Medical Centre Rostock

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2015-08-31
Completion
2017-08-31

Countries

  • Germany

Study Locations

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02051621 on ClinicalTrials.gov