All Inclusive KODEX - EPD™ Study Patient Specific Optimized Therapy (PSOT) Study

Arrythmia Clinical Trial

— PSOT  

Official title:

All Inclusive KODEX - EPD™ Study Patient Specific Optimized Therapy (PSOT) Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03619018
• Other study ID #: CLN-KODEX-0007
• Status: Not yet recruiting
• Start date: September 1, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: August 2018
• Source: EPD Research Ltd.
• Contact: G. André Ng, Prof.
• Phone: +44 (0)116 2502438
• Email: andre.ng[@]leicester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective, multi-center, non-randomized, open label, single arm study. Consented subjects who are scheduled to undergo ablation due to arrhythmia will be enrolled in the study. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 36 months.

KODEX - EPD™ system will be used in all procedures during treatment of cardiac arrhythmias.

Anonymized data will be stored in an EPD database and will be used to train and test predictors for personalized optimized therapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Subject or authorized representative, signed a written Informed Consent form to participate in the study, prior to any study related procedures.

2. Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.

Exclusion Criteria:

1. Pregnant women.

Related Conditions & MeSH terms

• Arrythmia

Intervention

Device:
• Data collection from Ablation therapy patients
Data collection from arrhythmia patients undergoing catheter-based electrophysiological (EP) intervention in order to develop a patient specific optimized therapy (PSOT).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EPD Research Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmia recurrence	The number of Arrhythmia recurrence	12 months
Secondary	Adverse Events	The number of Arrhythmia recurrence	12 Months