Radiofrequency Ablation of Atrial Fibrillation Under Apnea

NCT04170894 | Completed DMC

• 1 other identifier: 19-04020216
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Radiofrequency Ablation; Ablation; Arrhythmia

Outcome Measures

Primary Outcomes (7)

• Catheter Stability Metrics as measured by contact force variability.

  Contact force variability: Catheter stability metrics will be calculated as standard deviations of contact forces measured during the course of reach ablation region. Contact forces and their standard deviations will range between 0 and 60 grams.

  Day 1

• Catheter Stability Metrics as measured by maximum and minimum contact force.

  Maximum contact force: range between 0 and 60 grams

  Day 1

• Catheter Stability Metrics as measured by average contact force.

  Average contact force: range between 0 and 60 grams

  Day 1

• Catheter Stability Metrics as measured by catheter displacement.

  Catheter displacement (mean): range 0-10 mm

  Day 1

• Efficacy as measured by time to pulmonary vein isolation.

  Time to pulmonary vein isolation (minutes): expected range 60 - 180 minutes

  Day 1

• Efficacy as measured by percentage of veins isolated after first pass.

  Percentage of veins isolated after first pass: 0-100%

  Day 1

• Catheter Stability Metrics as measured by time to impedance drop.

  Time to 5 ohm and 10 ohm impedance drop: range 1 to 60 seconds

  Day 1

Secondary Outcomes (4)

• Procedural time as measured by the length of time from start to end of procedure.

  Day 1

• Clinical Outcomes as measured by recurrence of atrial fibrillation at six months post procedure.

  month six

• Clinical Outcomes as measured by recurrence of atrial fibrillation at 12 months post procedure.

  month 12

• Safety, as measured by number of subjects with at least one adverse event.

  End of study (12 months)

Study Arms (2)

Apnea

EXPERIMENTAL

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

Other: Periods of Apnea

Control

ACTIVE COMPARATOR

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.

Other: Control Arm - No Periods of Apnea

Interventions

Periods of Apnea OTHER

Periods of apnea throughout atrial fibrillation ablation.

Apnea

Control Arm - No Periods of Apnea OTHER

Standard of care atrial fibrillation ablation.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Northwell Health: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (6)

Southside Hospital

Bay Shore, New York, 11706, United States

Location

North Shore Hospital

Manhasset, New York, 11030, United States

Location

New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, 10065, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Long Island Jewish Medical Center

Queens, New York, 11040, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Gabriels JK, Ying X, Purkayastha S, Braunstein E, Liu CF, Markowitz SM, Mountantonakis S, Thomas G, Goldner B, Willner J, Goyal R, Ip JE, Lerman BB, Carter J, Bereanda N, Fitzgerald MM, Anca D, Patel A, Cheung JW. Safety and Efficacy of a Novel Approach to Pulmonary Vein Isolation Using Prolonged Apneic Oxygenation. JACC Clin Electrophysiol. 2023 Apr;9(4):497-507. doi: 10.1016/j.jacep.2022.10.030. Epub 2023 Jan 18.

  PMID: 36752460 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jim Cheung, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: October 8, 2020
• Primary Completion: March 31, 2022
• Study Completion: August 30, 2023
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)