Dipole Density Mapping in Supraventricular Tachycardia

NCT02469623 | Completed Results

• 6 other identifiers: CL-SVT-005CL-SVT-002CL-SVT-001CL-SVT-004CL-SVT-006CL-SVT-008
• Study Type: interventional
• Target: 85
• Locations: 6 countries
• Sites: 8

Brief Summary

Use of dipole density mapping to identify activation in complex supraventricular tachycardias.

Conditions

Supraventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events

  Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure. Each event was classified and adjudicated by the site-specific investigator. The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition.

  7 days

• The Number of Patients for Which Activation Maps Can be Created

  The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.

  1 day

Study Arms (1)

Dipole Density Mapping

EXPERIMENTAL

Device: Dipole Density Mapping with AcQMap followed by ablation

Interventions

Dipole Density Mapping with AcQMap followed by ablation DEVICE

Dipole Density Mapping

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be aged 18-75 years
• Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs.
• Be able and willing to give informed consent

You may not qualify if:

• Have any of the following:
• implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped
• permanent pacemaker or ICD leads in the chamber being mapped
• hypercoagulopathy or an inability to tolerate anticoagulation during the procedure
• Stents in the area of the pulmonary veins (Study CL-SVT-004 ONLY)
• MI within the prior two (2) months
• Cardiac surgery within the prior three (3) months
• Intracardiac thrombus
• Clinically significant tricuspid and/or mitral valve regurgitation or stenosis
• Cerebral ischemic event (including TIA) in the prior six (6) months
• Pregnant or nursing
• Currently enrolled in another clinical investigation
• Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY)
• Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY)
• Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY)

Sponsors & Collaborators

• Acutus Medical: lead

Study Sites (8)

AZ Sint-Jan AV Cardiologie

Bruges, 8000, Belgium

Location

Southlake Regional Health Center

Newmarket, Ontario, L3Y 2P9, Canada

Location

Pontificia Universidad Catolica de Chile

Santiago, Región Metropolitana, Chile

Location

Na Homolce Hospital

Prague, 150 30, Czechia

Location

Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf

Hamburg, D - 20246, Germany

Location

Papworth Hospital NHS Foundation Trust

Cambridge, CB23, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

Barts Health NHS Trust

Whitechapel, E1 1BB, United Kingdom

Location

Related Publications (1)

• Grace A, Willems S, Meyer C, Verma A, Heck P, Zhu M, Shi X, Chou D, Dang L, Scharf C, Scharf G, Beatty G. High-resolution noncontact charge-density mapping of endocardial activation. JCI Insight. 2019 Mar 21;4(6):e126422. doi: 10.1172/jci.insight.126422. eCollection 2019 Mar 21.

  PMID: 30895945 DERIVED

MeSH Terms

Conditions

Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Steve McQuillan, Sr. Vice President Regulatory, Clinical, & Quality Assurance
• Organization: Acutus Medical, Inc.

steven.mcquillan@acutus.com

442232608-

Study Officials

• Petr Neuzil, MD

  Nemocnice Na Homolce

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 11, 2015
• Study Start: September 6, 2014
• Primary Completion: May 22, 2017
• Study Completion: May 22, 2017
• Last Updated: September 18, 2019
• Results First Posted: September 18, 2019

Record last verified: 2019-08

Locations

DE (1); GB (3); CZ (1); BE (1); CA (1); CL (1)