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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irrigated ablation catheter and 5F balloon tipped PA catheter | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irrigated ablation catheter | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (during procedure) |
| 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. | Day 1 (during procedure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anand D Shah, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Clinic | Atlanta | Georgia | 30322 | United States | ||
| Emory University Hospital |
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Participants were recruited from the patient population at Emory University Hospital and the Emory Clinic, in Atlanta, Georgia who were scheduled to have a routine cardiac ablation using an irrigated ablation catheter for treatment of arrhythmia. Participants were enrolled between January 23, 2020 and May 18, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Irrigated Ablation Catheter and Balloon Tipped PA Catheter | Participants undergoing cardiac ablation had cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure) and a 5 French (5F) sized balloon tipped pulmonary artery (PA) catheter (for study purposes only). The catheter will be positioned in either the left or right side of the heart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Irrigated Ablation Catheter and Balloon Tipped PA Catheter | Participants undergoing cardiac ablation had 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants had the ablation catheter positioned in only one side of the heart. Nine participants had measurements obtained from the left atrium and ventricle chambers, and two participants had measurements obtained from the right atrium and ventricle chambers. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Day 1 (during procedure) |
|
Data on adverse events will be collected from the start of the procedure through the end of the procedure on Day 1 of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Irrigated Ablation Catheter | Participants undergoing cardiac ablation had cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anand Shah, MD | Emory University | 404-712-4063 | anand.d.shah@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2019 | May 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Balloon tipped PA catheter | 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. |
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Indication for Ablation | Count of Participants | Participants |
|
| Ejection Fraction | Mean | Standard Deviation | percentage of blood pumped |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Type of Atrial Fibrillation | Count of Participants | Participants |
|
| Balloon Tipped PA Catheter |
Participants undergoing cardiac ablation had cardiac pressures measured with a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only). |
|
|
| Primary | 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. | Participants had the ablation catheter positioned in only one side of the heart. Nine participants had measurements obtained from the left atrium and ventricle chambers, and two participants had measurements obtained from the right atrium and ventricle chambers. | Posted | Mean | Standard Deviation | mmHg | Day 1 (during procedure) |
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| Post-Hoc | Systolic Pressure Per Millisecond | The systolic pressure values per time, in milliseconds (ms), for the left ventricle chamber is presented for the irrigated ablation catheter derived measurements and the balloon tipped PA catheter measurements. | This analysis includes the nine participants had measurements obtained from the left ventricle chamber. | Posted | Mean | Standard Deviation | mmHg/ms | Day 1 (during procedure) |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Balloon Tipped PA Catheter | Participants undergoing cardiac ablation had cardiac pressures measured with a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only). | 0 | 11 | 0 | 11 | 0 | 11 |
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| Right ventricle |
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