Cardiac Arrhythmia
Conditions
Keywords
Cardiology, Electrophysiology
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Pressure Value | 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. |
| Diastolic Pressure Value | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Irrigated Ablation Catheter and Balloon Tipped PA Catheter | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 5 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Age, Continuous | 66.2 years STANDARD_DEVIATION 8.2 | — |
| Body Mass Index (BMI) | 31.7 kg/m^2 STANDARD_DEVIATION 4.6 | — |
| Ejection Fraction | 47.3 percentage of blood pumped STANDARD_DEVIATION 16.1 | — |
| Indication for Ablation Atrial fibrillation | 9 Participants | — |
| Indication for Ablation Ventricular tachycardia | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 11 Participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
| Type of Atrial Fibrillation No atrial fibrillation | 2 Participants | — |
| Type of Atrial Fibrillation Paroxysmal atrial fibrillation | 4 Participants | — |
| Type of Atrial Fibrillation Persistent atrial fibrillation | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
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.
Time frame: Day 1 (during procedure)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Irrigated Ablation Catheter | Diastolic Pressure Value | Left ventricle | 15.3 mmHg | Standard Deviation 4 |
| Irrigated Ablation Catheter | Diastolic Pressure Value | Right ventricle | 20.2 mmHg | Standard Deviation 5.2 |
| Balloon Tipped PA Catheter | Diastolic Pressure Value | Left ventricle | 17.3 mmHg | Standard Deviation 3.2 |
| Balloon Tipped PA Catheter | Diastolic Pressure Value | Right ventricle | 15.8 mmHg | Standard Deviation 4.6 |
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.
Time frame: Day 1 (during procedure)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Irrigated Ablation Catheter | Systolic Pressure Value | Left atrium | 26.5 millimeters of mercury (mmHg) | Standard Deviation 6.4 |
| Irrigated Ablation Catheter | Systolic Pressure Value | Right atrium | 16.6 millimeters of mercury (mmHg) | Standard Deviation 5.1 |
| Irrigated Ablation Catheter | Systolic Pressure Value | Left ventricle | 114.6 millimeters of mercury (mmHg) | Standard Deviation 33.4 |
| Irrigated Ablation Catheter | Systolic Pressure Value | Right ventricle | 42.8 millimeters of mercury (mmHg) | Standard Deviation 3.6 |
| Balloon Tipped PA Catheter | Systolic Pressure Value | Right ventricle | 54.1 millimeters of mercury (mmHg) | Standard Deviation 2.8 |
| Balloon Tipped PA Catheter | Systolic Pressure Value | Left atrium | 27.75 millimeters of mercury (mmHg) | Standard Deviation 7.4 |
| Balloon Tipped PA Catheter | Systolic Pressure Value | Left ventricle | 105.9 millimeters of mercury (mmHg) | Standard Deviation 30.4 |
| Balloon Tipped PA Catheter | Systolic Pressure Value | Right atrium | 13.6 millimeters of mercury (mmHg) | Standard Deviation 6.3 |
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.
Time frame: Day 1 (during procedure)
Population: This analysis includes the nine participants had measurements obtained from the left ventricle chamber.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Irrigated Ablation Catheter | Systolic Pressure Per Millisecond | 0.49 mmHg/ms | Standard Deviation 0.15 |
| Balloon Tipped PA Catheter | Systolic Pressure Per Millisecond | 0.53 mmHg/ms | Standard Deviation 0.11 |