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Hemodynamics Measurement in Radiofrequency Catheter Ablation

Primary Purpose

Cardiac Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Irrigated ablation catheter
Balloon tipped PA catheter
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Arrhythmia focused on measuring Cardiology, Electrophysiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient undergoing routine cardiac ablation of his/her arrhythmia with planned use of an irrigated ablation catheter

Exclusion Criteria:

  • inability to provide informed consent

Sites / Locations

  • Emory Clinic
  • Emory University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Irrigated ablation catheter and 5F balloon tipped PA catheter

Arm Description

Participants undergoing cardiac ablation will have cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure) and a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only).

Outcomes

Primary Outcome Measures

Systolic Pressure Value
The systolic pressure values for atrium and ventricle heart chambers are presented for the irrigated ablation catheter derived measurements and the balloon tipped PA catheter measurements.
Diastolic Pressure Value
The diastolic pressure values for ventricle heart chambers are presented for the irrigated ablation catheter derived measurements and the balloon tipped PA catheter measurements.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2020
Last Updated
May 17, 2021
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT04227119
Brief Title
Hemodynamics Measurement in Radiofrequency Catheter Ablation
Official Title
Hemodynamics Measurement in Radiofrequency Catheter Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
May 18, 2020 (Actual)
Study Completion Date
May 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will occur in patients undergoing routine cardiac ablation of his/her arrhythmia with planned use of an irrigated ablation catheter. The main objective of this study is to take intracardiac pressure measurements and pressure waveforms with both a "gold standard" balloon tipped pulmonary artery catheter placed for this study and an irrigated ablation catheter placed as standard of care for the procedure.
Detailed Description
Measuring internal heart pressures allows for the assessment and diagnosis of a variety of cardiac conditions which are commonly found in patients undergoing catheter ablation, including congestive heart failure, diastolic dysfunction, and valvular heart disease. Currently it is unknown if taking pressure measurements with the ablation catheter is accurate and it is not standard practice to insert the additional 'gold standard' pressure sensing catheter. Catheter ablation of cardiac arrhythmia is performed to offer symptomatic relief from a variety of atrial, ventricular and atrio-ventricular rhythms. Irrigated ablation catheters are commonly used for ablation of arrhythmias arising from the left heart and coronary sinus. These catheters contain internal channels allowing for infusion of an external fluid directly to the tip of the catheter, where the fluid is sprayed through numerous end holes allowing for cooling of the catheter ablation tip. Fluid filled catheters are also the primary tool utilized to assess intravascular and intracardiac pressures and hemodynamics in the cardiac catheterization suite and intensive care unit. However, the fluid filled catheters commonly used for these assessments are single lumen with a single end hole and generally have a larger minimal diameters compared to the ablation catheter. "Dampening" of pressure waveforms are observed in smaller diameter catheters and may lead to underestimation of peak pressure and overestimation of the nadir pressure gradient. It is unknown if transduction of pressures from the tip of an irrigated ablation catheter will yield equivalent results compared to use of a single 5 French (5F) sized lumen catheter. This study will seek to enroll patients already scheduled to have a cardiac ablation for a clinical arrhythmia at Emory University Hospital. After completion of the standard ablation, the ablation catheter will be positioned in the heart and pressures will be measured. Next, a standard pressure sensing catheter will be positioned in the same area in the heart and pressures will be measured. The pressure values for each heart chamber assessed will be compared between the catheters. The purpose of this study is to test the hypothesis that transduction of intracardiac pressures using an irrigated ablation catheter placed as standard of care for the ablation procedure is equivalent to transduction of pressures using a standard 5F balloon tipped PA catheter placed only for this research study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia
Keywords
Cardiology, Electrophysiology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irrigated ablation catheter and 5F balloon tipped PA catheter
Arm Type
Experimental
Arm Description
Participants undergoing cardiac ablation will have cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure) and a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only).
Intervention Type
Device
Intervention Name(s)
Irrigated ablation catheter
Intervention Description
After completion of ablation, the ablation catheter will be serially positioned in the cardiac chambers (either the left or right side of the heart). The stop cock will be turned to the pressure transducer and waveforms will be stored corresponding to each chamber.
Intervention Type
Device
Intervention Name(s)
Balloon tipped PA catheter
Intervention Description
After removal of the irrigated ablation catheter, a 5F balloon tipped PA catheter which will be positioned under fluoroscopic guidance in each previously evaluated chamber and the chambers will be measured again.
Primary Outcome Measure Information:
Title
Systolic Pressure Value
Description
The systolic pressure values for atrium and ventricle heart chambers are presented for the irrigated ablation catheter derived measurements and the balloon tipped PA catheter measurements.
Time Frame
Day 1 (during procedure)
Title
Diastolic Pressure Value
Description
The diastolic pressure values for ventricle heart chambers are presented for the irrigated ablation catheter derived measurements and the balloon tipped PA catheter measurements.
Time Frame
Day 1 (during procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient undergoing routine cardiac ablation of his/her arrhythmia with planned use of an irrigated ablation catheter Exclusion Criteria: inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand D Shah, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hemodynamics Measurement in Radiofrequency Catheter Ablation

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