Hemodynamics Measurement in Radiofrequency Catheter Ablation

Hemodynamics Measurement in Radiofrequency Catheter Ablation

Sponsors

Lead Sponsor: Emory University

Source Emory University
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 6F 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 6F balloon tipped PA catheter placed only for this research study.

Overall Status Completed
Start Date January 23, 2020
Completion Date May 18, 2020
Primary Completion Date May 18, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Systolic Pressure Value Day 1 (during procedure)
Diastolic Pressure Value Day 1 (during procedure)
Mean Pressure Value Day 1 (during procedure)
Wavform Tracing Day 1 (during procedure)
Enrollment 11
Condition
Intervention

Intervention Type: Device

Intervention Name: Irrigated ablation catheter

Description: After completion of ablation, the ablation catheter will be serially positioned in the cardiac chambers (left OR right atrium, left OR right ventricle). The stop cock will be turned to the pressure transducer and waveforms will be stored corresponding to each chamber.

Arm Group Label: Irrigated ablation catheter and 6F balloon tipped PA catheter

Intervention Type: Device

Intervention Name: Balloon tipped PA catheter

Description: After removal of the irrigated ablation catheter, a 6F balloon tipped PA catheter which will be positioned under fluoroscopic guidance in each previously evaluated chamber and the chambers will be measured again.

Arm Group Label: Irrigated ablation catheter and 6F balloon tipped PA catheter

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Anand D Shah, MD Principal Investigator Emory University
Location
Facility:
Emory Clinic | Atlanta, Georgia, 30322, United States
Emory University Hospital | Atlanta, Georgia, 30322, United States
Location Countries

United States

Verification Date

May 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Emory University

Investigator Full Name: Anand D Shah

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Irrigated ablation catheter and 6F balloon tipped PA catheter

Type: Experimental

Description: Participants undergoing cardiac ablation will have cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure) and a F6 balloon tipped pulmonary artery (PA) catheter (for study purposes only).

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov