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Half-normal Saline in Atrial Fibrillation Ablation

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ClinicalTrials.gov Identifier: NCT03498586
Recruitment Status : Not yet recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation

Brief Summary:
The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Half-normal saline Drug: Normal saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Half-normal saline Drug: Half-normal saline
Use of half-normal saline as an irrigant for open-irrigated ablation catheters
Active Comparator: Normal saline Drug: Normal saline
Use of normal saline as an irrigant for open-irrigated ablation catheters



Primary Outcome Measures :
  1. total radiofrequency ablation time, and total procedure time [ Time Frame: intraprocedural ]
  2. acute pulmonary veins, and left atrial appendage (if applicable) reconnection [ Time Frame: intraprocedural ]
  3. freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs [ Time Frame: 1 year ]
  2. long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection [ Time Frame: in case of a repeat procedure performed during the study follow-up (an average of 1 year) ]

Other Outcome Measures:
  1. procedure-related complications [ Time Frame: periprocedural (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. hyponatremia [ Time Frame: periprocedural (at the time of the procedure and up to 1 month) ]
    serum sodium level < 135 mEq/L



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • male or female between 18 and 75 years of age at the time of enrollment
  • undergoing first-time radiofrequency ablation for atrial fibrillation
  • written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion criteria

  • robotic-guided atrial fibrillation ablation
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498586


Locations
United States, Texas
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Responsible Party: Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT03498586     History of Changes
Other Study ID Numbers: TCAI_HNS_AF
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes