Ventricular Wall Motion Characterization

Completed

• Conditions: Atrial Fibrillation; Tachycardia, Ventricular

• Registration Number: NCT01629160
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The purpose of this study is to evaluate feasibility of using new technologies to characterize ventricular wall motion in patients indicated for mapping and ablation procedures. Echo will be performed preoperatively and patients will receive a 1-month followup telephone call.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-24
• Study First Submitted QC: 2012-06-24
• Study First Posted: 2012-06-27
• Study Start: 2012-07
• Primary Completion: 2014-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Be in sinus rhythm
• Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations
• Be undergoing mapping and ablation that requires left heart access for either ventricular tachycardia (VT) or atrial fibrillation (AF) according to HRS (Heart Rhythm Society)/ESC (European Society of Cardiology)/German National guidelines. The patient needs to have at least one of the following indications for left heart mapping and ablation to be included in the study: a) Symptomatic sustained monomorphic VT (SMVT), or b) Frequent PVCs, non-sustained VT, or VT that is presumed to cause ventricular dysfunction, or c) Bundle branch reentrant or interfascicular VTs, or d) Symptomatic AF with indication for ablation per current HRS/ESC/German National guidelines in a patient who is either 1) refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication, or 2) unable/unwilling to take antiarrhythmic drug therapy and chooses ablation as the first line of therapy

Exclusion Criteria

• Have permanent AF
• Exhibit Cheyne-Stokes respiration
• Have a recent myocardial infarction within 40 days prior to enrollment
• Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
• Have had a recent CVA or TIA within 3 months prior to enrollment
• Be less than 18 years of age
• Be pregnant
• Be currently participating in any other clinical investigation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of Ventricular Wall Motion Characterization	Mapping and Ablation Procedure

Trial Locations

Locations (1)

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany