Half-normal Saline in Atrial Flutter Ablation

NCT04001530 | Completed DMC

• 1 other identifier: 156-2019
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Flutter

Outcome Measures

Primary Outcomes (3)

• Time taken to produce bidirectional block

  intraprocedural

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

  intraprocedural

• Freedom from atrial flutter recurrence

  1 year

Secondary Outcomes (2)

• Time taken for termination of atrial flutter

  intraprocedural

• Total radiofrequency ablation time and procedural time

  intraprocedural

Other Outcomes (2)

• Incidence of procedure-related complications

  at the time of the procedure and up to 1 month

• Incidence of steam pops

  periprocedural

Study Arms (2)

Half-normal saline

EXPERIMENTAL

Use of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters

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

Drug: Normal Saline 0.9% Infusion Solution Bag

Interventions

Half Normal Saline 0.45% Infusion Solution Bag DRUG

Randomization to half normal saline

Half-normal saline

Normal Saline 0.9% Infusion Solution Bag DRUG

Randomization to normal saline

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Atrial Flutter

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff electrophysiologist Schulich Heart Program, Associate Professor University of Toronto

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: January 1, 2018
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-07

Locations

CA (1)