Ventricular Wall Motion Characterization

Characterization of Normal and Abnormal Ventricular Wall Motion

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01629160

Enrollment

Registered

2012-06-27

Start date

2012-07-31

Completion date

Unknown

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Tachycardia, Ventricular

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Feasibility of Ventricular Wall Motion Characterization	Mapping and Ablation Procedure

Countries

Germany

Outcome results