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Trial Outcomes & Findings for Hemodynamics Measurement in Radiofrequency Catheter Ablation (NCT NCT04227119)

NCT ID: NCT04227119

Last Updated: 2021-06-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Day 1 (during procedure)

Results posted on

2021-06-14

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
11
Overall Study
COMPLETED
11
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Irrigated Ablation Catheter and Balloon Tipped PA Catheter
n=11 Participants
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).
Age, Categorical
<=18 years
0 Participants
n=11 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=11 Participants
Age, Categorical
>=65 years
5 Participants
n=11 Participants
Age, Continuous
66.2 years
STANDARD_DEVIATION 8.2 • n=11 Participants
Sex: Female, Male
Female
4 Participants
n=11 Participants
Sex: Female, Male
Male
7 Participants
n=11 Participants
Region of Enrollment
United States
11 Participants
n=11 Participants
Indication for Ablation
Atrial fibrillation
9 Participants
n=11 Participants
Indication for Ablation
Ventricular tachycardia
2 Participants
n=11 Participants
Ejection Fraction
47.3 percentage of blood pumped
STANDARD_DEVIATION 16.1 • n=11 Participants
Body Mass Index (BMI)
31.7 kg/m^2
STANDARD_DEVIATION 4.6 • n=11 Participants
Type of Atrial Fibrillation
Paroxysmal atrial fibrillation
4 Participants
n=11 Participants
Type of Atrial Fibrillation
Persistent atrial fibrillation
5 Participants
n=11 Participants
Type of Atrial Fibrillation
No atrial fibrillation
2 Participants
n=11 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Irrigated Ablation Catheter
n=11 Participants
Participants undergoing cardiac ablation had cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure).
Balloon Tipped PA Catheter
n=11 Participants
Participants undergoing cardiac ablation had cardiac pressures measured with a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only).
Systolic Pressure Value
Left ventricle
114.6 millimeters of mercury (mmHg)
Standard Deviation 33.4
105.9 millimeters of mercury (mmHg)
Standard Deviation 30.4
Systolic Pressure Value
Left atrium
26.5 millimeters of mercury (mmHg)
Standard Deviation 6.4
27.75 millimeters of mercury (mmHg)
Standard Deviation 7.4
Systolic Pressure Value
Right atrium
16.6 millimeters of mercury (mmHg)
Standard Deviation 5.1
13.6 millimeters of mercury (mmHg)
Standard Deviation 6.3
Systolic Pressure Value
Right ventricle
42.8 millimeters of mercury (mmHg)
Standard Deviation 3.6
54.1 millimeters of mercury (mmHg)
Standard Deviation 2.8

PRIMARY outcome

Timeframe: 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.

The diastolic pressure values for ventricle heart chambers are presented for the irrigated ablation catheter derived measurements and the balloon tipped PA catheter measurements.

Outcome measures

Outcome measures
Measure
Irrigated Ablation Catheter
n=11 Participants
Participants undergoing cardiac ablation had cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure).
Balloon Tipped PA Catheter
n=11 Participants
Participants undergoing cardiac ablation had cardiac pressures measured with a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only).
Diastolic Pressure Value
Left ventricle
15.3 mmHg
Standard Deviation 4.0
17.3 mmHg
Standard Deviation 3.2
Diastolic Pressure Value
Right ventricle
20.2 mmHg
Standard Deviation 5.2
15.8 mmHg
Standard Deviation 4.6

POST_HOC outcome

Timeframe: Day 1 (during procedure)

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

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.

Outcome measures

Outcome measures
Measure
Irrigated Ablation Catheter
n=9 Participants
Participants undergoing cardiac ablation had cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure).
Balloon Tipped PA Catheter
n=9 Participants
Participants undergoing cardiac ablation had cardiac pressures measured with a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only).
Systolic Pressure Per Millisecond
0.49 mmHg/ms
Standard Deviation 0.15
0.53 mmHg/ms
Standard Deviation 0.11

Adverse Events

Irrigated Ablation Catheter

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Balloon Tipped PA Catheter

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anand Shah, MD

Emory University

Phone: 404-712-4063

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place