Radiofrequency Ablation of Atrial Fibrillation Under Apnea

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

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2023-08-30

Brief Summary

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This study seeks to assess the effect of apnea (breath hold) during atrial fibrillation (AF) ablation by having all ablations performed under apnea. By prospectively studying the effects of apnea on AF ablation, the investigators wish to demonstrate its feasibility, safety and impact on patient outcomes. This is a prospective study that includes both an apnea arm and a control arm. The subjects who consent to the apnea arm will undergo an atrial fibrillation ablation with periods of apnea. The subjects who consent to the control arm will agree to have their data from their standard of care atrial fibrillation be collected for comparison.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apnea

Patients will undergo an atrial fibrillation ablation and will have induced periods of apnea throughout the procedure.

Group Type EXPERIMENTAL

Periods of Apnea

Intervention Type OTHER

Periods of apnea throughout atrial fibrillation ablation.

Control

Patients who choose not to participate in the apnea arm will have the opportunity to consent to the control arm. These patients will undergo an atrial fibrillation ablation per standard of care without periods of apnea throughout the procedure. This data will be collected to use as a comparator to the apnea arm.

Group Type ACTIVE_COMPARATOR

Control Arm - No Periods of Apnea

Intervention Type OTHER

Standard of care atrial fibrillation ablation.

Interventions

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Periods of Apnea

Periods of apnea throughout atrial fibrillation ablation.

Intervention Type OTHER

Control Arm - No Periods of Apnea

Standard of care atrial fibrillation ablation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18 - 80 years old.
* Symptomatic paroxysmal atrial fibrillation.

Exclusion Criteria

* Patients with persistent or permanent atrial fibrillation or prior atrial fibrillation ablation.
* Significant chronic obstructive pulmonary disease (such as those requiring home oxygen).
* Severe pulmonary hypertension.
* Other intrinsic lung pathology such as interstitial lung disease.
* Severe systolic dysfunction defined as left ventricular ejection fraction \< 30%.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No