Clinical trial NCT01629160: Ventricular Wall Motion Characterization
Official title: Characterization of Normal and Abnormal Ventricular Wall Motion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Tachycardia, Ventricular
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atrial Fibrillation or Ventricular Tachycardia

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Ventricular Wall Motion Characterization
timeFrame: Mapping and Ablation Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
Study officials:
affiliation: Herzzentrum Leipzig GmbH
name: Gerhard Hindricks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piorkowski C, Arya A, Markovitz CD, Razavi H, Jiang C, Rosenberg S, Breithardt OA, Rolf S, John S, Kosiuk J, Huo Y, Doring M, Richter S, Ryu K, Gaspar T, Prinzen FW, Hindricks G, Sommer P. Characterizing left ventricular mechanical and electrical activation in patients with normal and impaired systolic function using a non-fluoroscopic cardiovascular navigation system. J Interv Card Electrophysiol. 2018 Apr;51(3):205-214. doi: 10.1007/s10840-018-0317-3. Epub 2018 Jan 31.