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Hemodynamics Measurement in Radiofrequency Catheter Ablation

Hemodynamics Measurement in Radiofrequency Catheter Ablation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04227119
Enrollment
11
Registered
2020-01-13
Start date
2020-01-23
Completion date
2020-05-18
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia

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.

DEVICEBalloon 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.

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Systolic Pressure ValueDay 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 ValueDay 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

ArmCount
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
Total11

Baseline characteristics

CharacteristicIrrigated 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, Continuous66.2 years
STANDARD_DEVIATION 8.2
Body Mass Index (BMI)31.7 kg/m^2
STANDARD_DEVIATION 4.6
Ejection Fraction47.3 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 11
other
Total, other adverse events
0 / 110 / 11
serious
Total, serious adverse events
0 / 110 / 11

Outcome results

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.

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.

ArmMeasureGroupValue (MEAN)Dispersion
Irrigated Ablation CatheterDiastolic Pressure ValueLeft ventricle15.3 mmHgStandard Deviation 4
Irrigated Ablation CatheterDiastolic Pressure ValueRight ventricle20.2 mmHgStandard Deviation 5.2
Balloon Tipped PA CatheterDiastolic Pressure ValueLeft ventricle17.3 mmHgStandard Deviation 3.2
Balloon Tipped PA CatheterDiastolic Pressure ValueRight ventricle15.8 mmHgStandard Deviation 4.6
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.

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.

ArmMeasureGroupValue (MEAN)Dispersion
Irrigated Ablation CatheterSystolic Pressure ValueLeft atrium26.5 millimeters of mercury (mmHg)Standard Deviation 6.4
Irrigated Ablation CatheterSystolic Pressure ValueRight atrium16.6 millimeters of mercury (mmHg)Standard Deviation 5.1
Irrigated Ablation CatheterSystolic Pressure ValueLeft ventricle114.6 millimeters of mercury (mmHg)Standard Deviation 33.4
Irrigated Ablation CatheterSystolic Pressure ValueRight ventricle42.8 millimeters of mercury (mmHg)Standard Deviation 3.6
Balloon Tipped PA CatheterSystolic Pressure ValueRight ventricle54.1 millimeters of mercury (mmHg)Standard Deviation 2.8
Balloon Tipped PA CatheterSystolic Pressure ValueLeft atrium27.75 millimeters of mercury (mmHg)Standard Deviation 7.4
Balloon Tipped PA CatheterSystolic Pressure ValueLeft ventricle105.9 millimeters of mercury (mmHg)Standard Deviation 30.4
Balloon Tipped PA CatheterSystolic Pressure ValueRight atrium13.6 millimeters of mercury (mmHg)Standard Deviation 6.3
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.

Time frame: Day 1 (during procedure)

Population: This analysis includes the nine participants had measurements obtained from the left ventricle chamber.

ArmMeasureValue (MEAN)Dispersion
Irrigated Ablation CatheterSystolic Pressure Per Millisecond0.49 mmHg/msStandard Deviation 0.15
Balloon Tipped PA CatheterSystolic Pressure Per Millisecond0.53 mmHg/msStandard Deviation 0.11

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026