Cardiac ArrhythmiaNCT04227119
Hemodynamics Measurement in Radiofrequency Catheter Ablation
A study testing Irrigated ablation catheter and Balloon tipped PA catheter in people with Cardiac Arrhythmia, run by Emory University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Irrigated ablation catheter and Balloon tipped PA catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jan 2020to 18 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing routine cardiac ablation of his/her arrhythmia with planned use of an irrigated ablation catheter
Who cannot join
- inability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Clinic
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
About this study
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.
Read the 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.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Irrigated ablation catheter, Balloon tipped PA catheter
- Keywords
- Cardiology, Electrophysiology
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigated ablation catheterDevice
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.
Balloon tipped PA catheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Irrigated ablation catheter; Device: Balloon tipped PA catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 (during procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start23 Jan 2020
- Primary completion18 May 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand D Shah, Emory University
- Investigators
- Anand D Shah, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227119
- Sponsor's protocol ID
- IRB00116832
- Status last verified
- May 2021
- First submitted
- 10 Jan 2020
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamics Measurement in Radiofrequency Catheter Ablation
- ClinicalTrials.gov ID
- NCT04227119
- Acronym / sponsor ID
- IRB00116832
- Conditions
- Cardiac Arrhythmia
- Keywords
- Cardiology, Electrophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irrigated ablation catheter and 5F balloon tipped PA catheter | Experimental | Device: Irrigated ablation catheter, Device: Balloon tipped PA catheterParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient undergoing routine cardiac ablation of his/her arrhythmia with planned use of an irrigated ablation catheter
Key exclusion criteria (1 listed)
- inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigated ablation catheterAfter 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 | Irrigated ablation catheter and 5F balloon tipped PA catheter |
| Balloon tipped PA catheterAfter 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. | Device | Irrigated ablation catheter and 5F balloon tipped PA catheter |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrhythmia
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand D Shah, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigated ablation catheter and Balloon tipped PA catheter in people with Cardiac Arrhythmia, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Pressure Value (time frame: Day 1 (during procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.