Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Atrial Fibrillation Ablation

Half-normal Saline in Atrial Fibrillation Ablation



Sponsors


Source

Texas Cardiac Arrhythmia Research Foundation

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2018-04-01

Completion Date

2020-04-01

Primary Completion Date

2020-04-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

total radiofrequency ablation time, and total procedure time
intraprocedural
acute pulmonary veins, and left atrial appendage (if applicable) reconnection
intraprocedural
freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs
1 year

Secondary Outcome

Measure

Time Frame

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

Enrollment

100

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

Half-normal saline


Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

Normal saline



Eligibility

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

Gender

All

Minimum Age

18 Years

Maximum Age

75 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Andrea Natale, MD
Principal Investigator
Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Location

Facility

Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Austin Texas 78705 United States

Location Countries

Country

United States


Verification Date

2018-04-01

Lastchanged Date

2018-04-12

Firstreceived Date

2018-04-04

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Texas Cardiac Arrhythmia Research Foundation

Investigator Full Name

Andrea Natale

Investigator Title

Executive Medical Director


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Half-normal saline

Arm Group Type

Experimental


Arm Group Label

Normal saline

Arm Group Type

Active Comparator



Firstreceived Results Date

N/A

Other Outcome

Measure

procedure-related complications

Time Frame

periprocedural (at the time of the procedure and up to 1 month)

Description

pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, phrenic nerve injury, pulmonary vein stenosis, atrio-esophageal fistula, death


Measure

hyponatremia

Time Frame

periprocedural (at the time of the procedure and up to 1 month)

Description

serum sodium level < 135 mEq/L



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Other

Masking

Double (Participant, Investigator)


Study First Submitted

April 4, 2018

Study First Submitted Qc

April 12, 2018

Study First Posted

April 13, 2018

Last Update Submitted

April 12, 2018

Last Update Submitted Qc

April 12, 2018

Last Update Posted

April 13, 2018


ClinicalTrials.gov processed this data on April 13, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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