Hemodynamics Measurement in Radiofrequency Catheter Ablation

NCT ID: NCT04227119

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-23
• Study Completion Date: 2020-05-18

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.

Conditions

Cardiac Arrhythmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Irrigated ablation catheter and 5F balloon tipped PA catheter

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).

Group Type: EXPERIMENTAL

Irrigated ablation catheter

Intervention Type: DEVICE

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.

Balloon tipped PA catheter

Intervention Type: DEVICE

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.

Interventions

Irrigated ablation catheter

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

Balloon tipped PA catheter

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Anand D Shah

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anand D Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Clinic

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00116832

Identifier Type: -

Identifier Source: org_study_id