Atrial FlutterNCT04001530
Half-normal Saline in Atrial Flutter Ablation
A study testing Half Normal Saline 0.45% Infusion Solution Bag and Normal Saline 0.9% Infusion Solution Bag in people with Atrial Flutter, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
To assess the acute and long-term efficacy of half-normal saline compared to normal saline for irrigation of open-irrigated catheters during catheter ablation for the treatment of cavotricuspid isthmus dependent atrial flutter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- Half Normal Saline 0.45% Infusion Solution Bag and Normal Saline 0.9% Infusion Solution Bag
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 31 Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age at the time of enrollment
- Patients presenting for right sided typical atrial flutter ablation who have a clinical indication to undergo catheter ablation
- Fully informed written informed consent by either the subject or subject's legal representative and ability for subject to comply with study responsibilities
Who cannot join
- The presence of thrombus within the left atrial appendage
- Prior catheter ablation of the cavotricuspid isthmus for right sided atrial flutter
- The inability to provide consent or comply with study requirements
- A predicted life expectancy of < 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verification of Half Normal Saline as a Superior Irrigant in the Catheter Radiofrequency Ablation of Typical Cavotricuspid Isthmus Dependent Atrial Flutter: A Multicenter Study
To assess the acute and long-term efficacy of half-normal saline compared to normal saline for irrigation of open-irrigated catheters during catheter ablation for the treatment of cavotricuspid isthmus dependent atrial flutter.
Read the detailed description
It is unclear whether ionic strength affects energy delivery and ablation lesion size during radiofrequency ablation for atrial flutter. Given that saline contains ionic sodium and chloride in the solution, it has conductive properties that may disperse radiofrequency energy away from the tip-tissue interface, thereby reducing current density and lesion size compared to ablation with nonionic solutions. The efficacy of half-normal saline will be measured by the time taken to create bidirectional block across the cavotricuspid isthmus as well as the acute recurrence rate within 30 minutes of the initial occurrence of bidirectional block and the 1 year freedom from flutter recurrence.
- Conditions
- Atrial Flutter
- Being tested
- Half Normal Saline 0.45% Infusion Solution Bag, Normal Saline 0.9% Infusion Solution Bag
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Half Normal Saline 0.45% Infusion Solution BagDrug
Randomization to half normal saline
Normal Saline 0.9% Infusion Solution BagDrug
Randomization to normal saline
| Study group | Role | What they receive |
|---|---|---|
| Half-normal saline | Experimental | Use of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters Receives: Drug: Half Normal Saline 0.45% Infusion Solution Bag |
| Normal saline | Active comparator | Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters Receives: Drug: Normal Saline 0.9% Infusion Solution Bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to produce bidirectional block
Measured: intraprocedural
Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block
Measured: intraprocedural
Freedom from atrial flutter recurrence
Measured: 1 year
Secondary outcomes (2)
Time taken for termination of atrial flutter
Measured: intraprocedural
Total radiofrequency ablation time and procedural time
Measured: intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Jan 2018
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FlutterStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Benedict Glover, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001530
- Sponsor's protocol ID
- 156-2019
- Status last verified
- Jul 2021
- First submitted
- 26 Jun 2019
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Multicentre study, patient data deidentified for post-enrolment analysis
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Half Normal Saline as a Superior Irrigant in the Catheter Radiofrequency Ablation of Typical Cavotricuspid Isthmus Dependent Atrial Flutter: A Multicenter Study
- ClinicalTrials.gov ID
- NCT04001530
- Acronym / sponsor ID
- 156-2019
- Conditions
- Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 28 Jun 2019 (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.
To assess the acute and long-term efficacy of half-normal saline compared to normal saline for irrigation of open-irrigated catheters during catheter ablation for the treatment of cavotricuspid isthmus dependent atrial flutter.
Detailed description
It is unclear whether ionic strength affects energy delivery and ablation lesion size during radiofrequency ablation for atrial flutter. Given that saline contains ionic sodium and chloride in the solution, it has conductive properties that may disperse radiofrequency energy away from the tip-tissue interface, thereby reducing current density and lesion size compared to ablation with nonionic solutions. The efficacy of half-normal saline will be measured by the time taken to create bidirectional block across the cavotricuspid isthmus as well as the acute recurrence rate within 30 minutes of the initial occurrence of bidirectional block and the 1 year freedom from flutter recurrence.
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 0.45% Infusion Solution BagUse of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters |
| Normal saline | Active comparator | Drug: Normal Saline 0.9% Infusion Solution BagUse of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years of age at the time of enrollment
- Patients presenting for right sided typical atrial flutter ablation who have a clinical indication to undergo catheter ablation
- Fully informed written informed consent by either the subject or subject's legal representative and ability for subject to comply with study responsibilities
Key exclusion criteria (4 listed)
- The presence of thrombus within the left atrial appendage
- Prior catheter ablation of the cavotricuspid isthmus for right sided atrial flutter
- The inability to provide consent or comply with study requirements
- A predicted life expectancy of < 12 months
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 Saline 0.45% Infusion Solution BagRandomization to half normal saline | Drug | Half-normal saline |
| Normal Saline 0.9% Infusion Solution BagRandomization to normal saline | Drug | Normal saline |
Primary outcome
Time taken to produce bidirectional block
Time frame: intraprocedural
Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block
Time frame: intraprocedural
Freedom from atrial flutter recurrence
Time frame: 1 year
2 secondary outcomes
Time taken for termination of atrial flutter
Time frame: intraprocedural
Total radiofrequency ablation time and procedural time
Time frame: intraprocedural
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 6 Jul 2021.
- Individual participant dataSharing planned: Undecided. Multicentre study, patient data deidentified for post-enrolment analysis
Related trials for Atrial Flutter
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
Recruiting
Atrial Flutter Ablation in the iCMR
Atrial Flutter Typical
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 0.45% Infusion Solution Bag and Normal Saline 0.9% Infusion Solution Bag in people with Atrial Flutter, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Time taken to produce bidirectional block (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 6 Jul 2021.