Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation

NCT04438395 | Unknown FDA Device

• 1 other identifier: CLN-00016
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• The feasibility of KODEX-EPD tissue pressure (TP) application

  • will be evaluated based on comparison with qualitative assessment of catheter contact by the physician during the procedure. We will ask the physician to estimate the level of pressure applied by categorizing the pressure as: no touch, touch (light), touch (firm), or high touch.

  During procedure

• The feasibility of KODEX-EPD tissue thickness application

  * thickness values will be evaluated by checking whether they are in the range of what can be expected based on feedback from the physician upon review after the treatment (measured in mm) * reproducibility of thickness assessment with KODEX-EPD will be calculated from repeat assessments of the same line (measured in mm) * relative thickness values will be compared against relative thickness values measured with ICE (measured in mm) * relative thickness values will be compared against relative thickness values derived from pre-procedural CT (measured in mm)

  During procedure

• The feasibility of KODEX-EPD lesion transmurality application

  • will be evaluated by checking whether assessments are reasonable from what can be expected based on feedback from the physician upon review after the treatment. The physician's response will be recorded as yes or no for transmurality.

  During procedure

Study Arms (1)

Enrolled AFL and AF Patients

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

Device: Cardiac ablation via catheter

Interventions

Cardiac ablation via catheter DEVICE

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

Enrolled AFL and AF Patients

Eligibility Criteria

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

Study Population

Patients with Atrial Flutter and patients with Atrial Fibrillation scheduled to undergo RF ablation of the cavotricuspid isthmus (CTI). 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:

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

You may not qualify if:

• Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
• Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
• Patient had experienced previous stroke (TIA or CVA).
• Thrombi detected in the heart.
• Known marked valvular insufficiency (moderate-severe and severe)
• Life expectancy less than 12 months.
• 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).
• Subjects that according to the clinical judgment of the caring physician do not fit for the study.
• Previous right atrial ablation procedure or cardiac ablation procedure performed within 90 days prior to enrollment.

Sponsors & Collaborators

• EPD Solutions, A Philips Company: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Larry Chinitz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anneleen Viville

CONTACT

+32479983495; Anneleen.Viville@philips.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 18, 2020
• Study Start: July 20, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

US (1)