Ventricular Wall Motion Characterization

Atrial Fibrillation Clinical Trial

Official title:

Characterization of Normal and Abnormal Ventricular Wall Motion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629160
• Other study ID #: 642
• Status: Completed
• Start date: July 2012

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Tachycardia
• Tachycardia, Ventricular

Locations

Country	Name	City	State
Germany	Herzzentrum Leipzig GmbH	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Ventricular Wall Motion Characterization		Mapping and Ablation Procedure