Atrial FibrillationNCT03498586
Half-normal Saline in Atrial Fibrillation Ablation
A study testing Half-normal saline and Normal saline in people with Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 2 sites in 2 countries.
Trial summary
The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Half-normal saline and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 May 2018to 2 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female between 18 and 75 years of age at the time of enrollment
- undergoing first-time radiofrequency ablation for atrial fibrillation
- written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Who cannot join
- robotic-guided atrial fibrillation ablation
- baseline hyponatremia (serum sodium level < 135 mEq/L)
- pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Austin, Texas, 78705
About this study
Official title: Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation
The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.
- Conditions
- Atrial Fibrillation
- Being tested
- Half-normal saline, Normal saline
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Half-normal salineDrug
Use of half-normal saline as an irrigant for open-irrigated ablation catheters
Normal salineDrug
Use of normal saline as an irrigant for open-irrigated ablation catheters
| Study group | Role | What they receive |
|---|---|---|
| Half-normal saline | Experimental | Not described Receives: Drug: Half-normal saline |
| Normal saline | Active comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
total radiofrequency ablation time, and total procedure time
Measured: intraprocedural
acute pulmonary veins, and left atrial appendage (if applicable) reconnection
Measured: intraprocedural
freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs
Measured: 1 year
Secondary outcomes (2)
freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs
Measured: 1 year
long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection
Measured: in case of a repeat procedure performed during the study follow-up (an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start2 May 2018
- Primary completion2 May 2019
- Study completion2 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Andrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Institute, St. David's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498586
- Sponsor's protocol ID
- TCAI_HNS_AF
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT03498586
- Acronym / sponsor ID
- TCAI_HNS_AF
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2020 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Half-normal saline | Experimental | Drug: Half-normal saline |
| Normal saline | Active comparator | Drug: Normal saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female between 18 and 75 years of age at the time of enrollment
- undergoing first-time radiofrequency ablation for atrial fibrillation
- written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Key exclusion criteria (4 listed)
- robotic-guided atrial fibrillation ablation
- baseline hyponatremia (serum sodium level < 135 mEq/L)
- pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
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 |
|---|---|---|
| Half-normal salineUse of half-normal saline as an irrigant for open-irrigated ablation catheters | Drug | Half-normal saline |
| Normal salineUse of normal saline as an irrigant for open-irrigated ablation catheters | Drug | Normal saline |
Primary outcome
total radiofrequency ablation time, and total procedure time
Time frame: intraprocedural
acute pulmonary veins, and left atrial appendage (if applicable) reconnection
Time frame: intraprocedural
freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs
Time frame: 1 year
2 secondary outcomes
freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs
Time frame: 1 year
long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection
Time frame: in case of a repeat procedure performed during the study follow-up (an average of 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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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.
Andrea Natale, MD principal investigator
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Half-normal saline and Normal saline in people with Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 2 sites in 2 countries.
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 3 inclusion and 4 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 5 Apr 2022. 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, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
total radiofrequency ablation time, and total procedure time (time frame: intraprocedural). The study lists 3 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 5 Apr 2022.