Ventricular ArrythmiaNCT03502499
Half-normal Saline in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation
A study testing Half-normal saline and Normal saline in people with Ventricular Arrythmia, run by Texas Cardiac Arrhythmia Research Foundation at 2 sites in United States.
Trial summary
The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during left ventricular outflow tract ventricular arrhythmias ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventricular Arrythmia
- What is being tested?
- Half-normal saline and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 May 2018to Apr 2022
- 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 left ventricular outflow tract ventricular arrhythmias
- 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
- ventricular arrhythmias originating from the right ventricular outflow tract according to the ventricular arrhythmia ECG morphology (i.e., precordial R wave transition at V3 or later)
- ventricular arrhythmias not originating from cardiac outflow tracts
- 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 1 country.
United States2 sites
University of Colorado Hospital
Aurora, Colorado, 80045
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 Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation
The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during left ventricular outflow tract ventricular arrhythmias 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
- Ventricular Arrythmia
- Being tested
- Half-normal saline, Normal saline
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 success
elimination of the VAs, or <10 morphologically similar PVCs during a 15-minute waiting period
Measured: intraprocedural
long-term success
elimination of the VAs, or a reduction of >75% of the PVC burden associated with marked improved in symptoms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start16 May 2018
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies 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
- 50 participants (estimated)
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
- NCT03502499
- Sponsor's protocol ID
- TCAI_HNS_VA
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2018
- Last updated
- 11 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 11 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 Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation
- ClinicalTrials.gov ID
- NCT03502499
- Acronym / sponsor ID
- TCAI_HNS_VA
- Conditions
- Ventricular Arrythmia
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: slow enrollment
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 18 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 left ventricular outflow tract ventricular arrhythmias 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 left ventricular outflow tract ventricular arrhythmias
- 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 (5 listed)
- ventricular arrhythmias originating from the right ventricular outflow tract according to the ventricular arrhythmia ECG morphology (i.e., precordial R wave transition at V3 or later)
- ventricular arrhythmias not originating from cardiac outflow tracts
- 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 success
Time frame: intraprocedural
elimination of the VAs, or <10 morphologically similar PVCs during a 15-minute waiting period
long-term success
Time frame: 1 year
elimination of the VAs, or a reduction of >75% of the PVC burden associated with marked improved in symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
Related trials for Ventricular Arrythmia
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
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
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 1 country: 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 Ventricular Arrythmia, run by Texas Cardiac Arrhythmia Research Foundation 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 3 inclusion and 5 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: paused, as of the sponsor's last update on 11 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. 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?
Results are not available in the source record.
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 11 Apr 2022.