RMN Versus Manual Epicardial Retrospective PMCF

NCT04171479 | Completed DMC FDA Device

• 1 other identifier: CLIN-024
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 3

Brief Summary

Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or remote magnetic navigation. Subjects will be compared with regards to safety, efficacy and mortality.

Conditions

Ventricular Tachycardia; Premature Ventricular Contraction

Outcome Measures

Primary Outcomes (2)

• Acute Success

  Characterize acute success rates for both groups. Acute success for VT procedures is defined as non-inducibility of clinical VT and/or other monomorphic VT at the end of the index-procedure. Acute success for PVC procedures is defined as no recurrence and non-inducibility of culprit PVC at the end of the index-procedure.

  intra-operative

• Procedural Safety: rates of device-and procedure-related serious adverse events

  Assess rates of device-and procedure-related serious adverse events in both groups.

  48 hours post index procedure

Secondary Outcomes (5)

• Chronic Success

  1 year post index procedure

• Chronic Safety: rates of device-or procedure-related serious adverse events

  1 year post index procedure

• Mortality

  1 year post index procedure

• Chronic Success

  At last follow up visit, estimated up to 6 years post-procedure for some patients

• Chronic Safety: rates of device-or procedure-related serious adverse events

  At last follow up visit, estimated up to 6 years post-procedure for some patients

Study Arms (2)

Manual

Subjects who underwent epicardial mapping and/or ablation using a manual technique will comprise this group.

Device: Epicardial mapping and/or ablation

Remote Magnetic Navigation

Subjects who underwent epicardial mapping and/or ablation using a remote magnetic technique (using Stereotaxis Niobe system) will comprise this group.

Device: Epicardial mapping and/or ablation

Interventions

Epicardial mapping and/or ablation DEVICE

Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.

Manual; Remote Magnetic Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have undergone an epicardial cardiac mapping and ablation procedure using either manual or remote magnetic (using Stereotaxis Niobe system) guidance.

You may qualify if:

• years of age or older
• Have undergone an epicardial RF mapping and/or ablation for a ventricular tachycardia (VT) as standard of care treatment using either the Niobe MNS or a manual approach
• Index procedure was conducted between July 1, 2013-present date.

Sponsors & Collaborators

• Stereotaxis: lead

Study Sites (3)

Na Homolce Hospital

Prague, Czechia

Location

OLVG Hospital

Amsterdam, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: November 21, 2019
• Study Start: October 2, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

CZ (1); NL (2)