Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study

NCT03481413 | Terminated FDA Device

• 1 other identifier: CLN-KODEX-0007
• Study Type: observational
• Target: 566
• Locations: 8 countries
• Sites: 22

Brief Summary

Study to evaluate the safety and procedural performance of the KODEX - EPD System when used in the treatment of cardiac arrhythmias. An additional objective is to develop patient specific optimized therapy (PSOT PMCF) via machine learning to improve future treatment of cardiac arrhythmias (PSOT).

Conditions

Arrythmia

Outcome Measures

Primary Outcomes (2)

• Acute safety event rate when using the KODEX - EPD System

  The primary safety event rate will be measured against a pre-specified performance goal of 12% and include serious system- or procedure-related adverse events occurring within 7 days of the index procedure

  7 days

• The success rate of the index ablation procedure.

  A procedure is defined as successful if the following conditions are met: 1. KODEX - EPD System was the only mapping system used in the index ablation procedure. 2. The primary arrhythmia was terminated and validated by operators' standard clinical practice (e.g., pacing).

  Index procedure

Secondary Outcomes (2)

• 12-month safety event rate when the KODEX - EPD System was used in the index ablation procedure and any additional unplanned follow-up procedures.

  12 months

• Develop PSOT for cardiac arrhythmia patients.

  Index procedure

Interventions

Ablation DEVICE

Ablation therapy for cardiac arrhythmias

Eligibility Criteria

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

Study Population

Arrhythmia patients indicated for EP procedures. Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study.

You may qualify if:

• Subjects who are eligible for an ablation procedure based on local guidelines,
• Subjects must be 18 years of age or above and at a legal age to give informed consent specific to state and national laws
• Subjects must be able and willing to comply with all follow-up requirements

You may not qualify if:

• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal; method of assessment upon the discretion of the investigator),
• Life expectancy less than 12 months,
• Participation in a concurrent clinical study without prior approval from EPD Solutions.
• Any contra-indication to use KODEX-EPD System per User Manual.
• Unrecovered/unresolved adverse events from any previous invasive procedure

Sponsors & Collaborators

• EPD Solutions, A Philips Company: lead

Study Sites (22)

Dignity Health Research Institute

Sacramento, California, 95819, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, Belgium

Location

AZ Sint Jan

Bruges, Belgium

Location

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, 32545, Germany

Location

HELIOS Klinikum Erfurt

Erfurt, 99089, Germany

Location

Klinikum Fürth

Fürth, 190766, Germany

Location

Universitätsklinikum Hamburg-Eppendorf (UKE Hamburg)

Hamburg, 20246, Germany

Location

Kardiologische Gemeinschaftspraxis am Park Sanssouci

Potsdam, 14471, Germany

Location

Hadassah University Medical centrum

Jerusalem, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Clinica Montevergine

Mercogliano, Italy

Location

Monzino Cardiologic Centre, University of Milan.

Milan, Italy

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Maastricht UMC

Maastricht, 6229, Netherlands

Location

Sint Anthonius ziekenhuis

Utrecht, Netherlands

Location

Fondazione Cardiocentro Ticino

Lugano, Switzerland

Location

Glenfield Hospital-University of Leicester

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anish Amin, MD

  OhioHealth Riverside Methodist Hospital

  PRINCIPAL INVESTIGATOR

• Yitschak Biton, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Min Tang, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 29, 2018
• Study Start: November 30, 2018
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3); BE (2); CH (1); IL (2); DE (5); US (6); IT (2); GB (1)