Recruiting

Dielectric Tissue Imaging

Sponsor:

EPD Solutions, A Philips Company

Code:

NCT04438395

Conditions

Atrial Fibrillation and Flutter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac ablation via catheter

Study Details

Brief summary:

This is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality.

Conditions

Atrial Fibrillation and Flutter

Study ID

NCT04438395

Start date

Jul 20, 2020

Status verified date

May, 2022

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subject must be aged >18 years.
2. Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
3. Subject must be willing to comply with the protocol requirements.
4. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
5. Subject is deemed amenable to therapeutic ablation for atrial flutter or atrial fibrillation.

Exclusion Criteria:

1. Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
2. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
3. Patient had experienced previous stroke (TIA or CVA).
4. Thrombi detected in the heart.
5. Known marked valvular insufficiency (moderate-severe and severe)
6. Life expectancy less than 12 months.
7. Known severe renal insufficiency (stages G4 and G5, characterized by severe reduction in GFR \[15-29 ml/min/1.73 m2\] and GFR \[<15 ml/min/1.73 m2\], respectively).
8. Subjects that according to the clinical judgment of the caring physician do not fit for the study.
9. Previous right atrial ablation procedure or cardiac ablation procedure performed within 90 days prior to enrollment.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Enrolled AFL and AF Patients

All subjects that are enrolled are group one, as there is only one group of subjects in this study

Interventions

Cardiac ablation via catheter

Cardiac ablation with a catheter to treat atrial flutter and/or atrial fibrillation

Primary outcome measure

  • The feasibility of KODEX-EPD tissue pressure (TP) application [ Time Frame: During procedure ]
  • The feasibility of KODEX-EPD tissue thickness application [ Time Frame: During procedure ]
  • The feasibility of KODEX-EPD lesion transmurality application [ Time Frame: During procedure ]

Central Contacts and Locations

Central contacts

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Chinitz

More Information

Sponsor

EPD Solutions, A Philips Company

Last update posted

May 6, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by EPD Solutions, A Philips Company on 2022-05-06.