CompletedNot Applicable

Half-normal Saline in Atrial Flutter Ablation

Canada4 participantsStarted 2018-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time taken to produce bidirectional block

Timeframe: intraprocedural

Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block

Timeframe: intraprocedural

Freedom from atrial flutter recurrence

Timeframe: 1 year

Trial details

NCT IDNCT04001530

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-31

View on ClinicalTrials.gov More Atrial Flutter trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.