Radiofrequency Ablation of Atrial Fibrillation Under Apnea

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: Control Arm - No Periods of Apnea; Other: Periods of Apnea

Study type: Interventional

Funder types: Other

Identifiers

NCT04170894

19-04020216

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Apnea

Experimental group

Description:

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

Treatment:

Other: Periods of Apnea

Control

Active Comparator group

Description:

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.

Treatment:

Other: Control Arm - No Periods of Apnea