Half-normal Saline in Atrial Fibrillation Ablation

NCT ID: NCT03498586

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2020-05-02

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Half-normal saline

Group Type EXPERIMENTAL

Half-normal saline

Intervention Type DRUG

Use of half-normal saline as an irrigant for open-irrigated ablation catheters

Normal saline

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

Use of normal saline as an irrigant for open-irrigated ablation catheters

Interventions

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Half-normal saline

Use of half-normal saline as an irrigant for open-irrigated ablation catheters

Intervention Type DRUG

Normal saline

Use of normal saline as an irrigant for open-irrigated ablation catheters

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Andrea Natale

Executive Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Locations

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Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Austin, Texas, United States

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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TCAI_HNS_AF

Identifier Type: -

Identifier Source: org_study_id

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