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出境医 / 临床实验 / Half-normal Saline in Atrial Flutter Ablation

Half-normal Saline in Atrial Flutter Ablation

Study Description
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.

Condition or disease Intervention/treatment Phase
Atrial Flutter Drug: Half Normal Saline 0.45% Infusion Solution Bag Drug: Normal Saline 0.9% Infusion Solution Bag Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Half-normal saline
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
Randomization to half normal saline
Active Comparator: Normal saline
Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters
 Drug: Normal Saline 0.9% Infusion Solution Bag
Randomization to normal saline
Outcome Measures
Primary Outcome Measures :
  1. Time taken to produce bidirectional block [ Time Frame: intraprocedural ]
  2. Acute recurrence rate < 30 minutes of initial occurrence of bidirectional block [ Time Frame: intraprocedural ]
  3. Freedom from atrial flutter recurrence [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time taken for termination of atrial flutter [ Time Frame: intraprocedural ]
  2. Total radiofrequency ablation time and procedural time [ Time Frame: intraprocedural ]

Other Outcome Measures:
  1. Incidence of procedure-related complications [ Time Frame: at the time of the procedure and up to 1 month ]
    pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, phrenic nerve injury, pulmonary vein stenosis, atrio-esophageal fistula, death

  2. Incidence of steam pops [ Time Frame: periprocedural ]
    marker of excessive heating of the tissue


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Benedict M. Glover, MD 4164806100 ext 7383 benedict.glover@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Benedict M. Glover, MD    4164806100 ext 7383    benedict.glover@sunnybrook.ca   
Contact: Catherine Parry, BA, CHIM    4164804276    catherine.parry@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Time taken for termination of atrial flutter [ Time Frame: intraprocedural ]
  • Total radiofrequency ablation time and procedural time [ Time Frame: intraprocedural ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2019)
  • Incidence of procedure-related complications [ Time Frame: at the time of the procedure and up to 1 month ]
    pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, phrenic nerve injury, pulmonary vein stenosis, atrio-esophageal fistula, death
  • Incidence of steam pops [ Time Frame: periprocedural ]
    marker of excessive heating of the tissue
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Half-normal Saline in Atrial Flutter Ablation
Official Title  ICMJE Verification of Half Normal Saline as a Superior Irrigant in the Catheter Radiofrequency Ablation of Typical Cavotricuspid Isthmus Dependent Atrial Flutter: A Multicenter Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Atrial Flutter
Intervention  ICMJE
  • Drug: Half Normal Saline 0.45% Infusion Solution Bag
    Randomization to half normal saline
  • Drug: Normal Saline 0.9% Infusion Solution Bag
    Randomization to normal saline
Study Arms  ICMJE
  • Experimental: Half-normal saline
    Use of half-normal saline (0.45% NaCl) as an irrigant for open-irrigated ablation catheters
    Intervention: Drug: Half Normal Saline 0.45% Infusion Solution Bag
  • Active Comparator: Normal saline
    Use of normal saline (0.9% NaCl) as an irrigant for open-irrigated ablation catheters
    Intervention: Drug: Normal Saline 0.9% Infusion Solution Bag
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001530
Other Study ID Numbers  ICMJE 156-2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Multicentre study, patient data deidentified for post-enrolment analysis
Responsible Party Dr. Benedict Glover, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sunnybrook Health Sciences Centre
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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