Hemodynamics Measurement in Radiofrequency Catheter Ablation

May 17, 2021 updated by: Anand D Shah, Emory University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Device: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Pressure Value
Time Frame: Day 1 (during procedure)
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.
Day 1 (during procedure)
Diastolic Pressure Value
Time Frame: Day 1 (during procedure)
The diastolic pressure values for ventricle heart chambers are presented for the irrigated ablation catheter derived measurements and the balloon tipped PA catheter measurements.
Day 1 (during procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Anand D Shah, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2020

Primary Completion (Actual)

May 18, 2020

Study Completion (Actual)

May 18, 2020

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00116832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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