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Completed

NCT Number: NCT04170894

Radiofrequency Ablation of Atrial Fibrillation Under Apnea

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southside Hospital, Bay Shore, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Periods of Apnea

Other

Periods of apnea throughout atrial fibrillation ablation.

Control Arm - No Periods of Apnea

Other

Standard of care atrial fibrillation ablation.

Primary outcomes

  1. Catheter Stability Metrics as measured by contact force variability.

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    Maximum contact force: range between 0 and 60 grams

  3. Catheter Stability Metrics as measured by average contact force.

    Time frame: Day 1

    Average contact force: range between 0 and 60 grams

  4. Catheter Stability Metrics as measured by catheter displacement.

    Time frame: Day 1

    Catheter displacement (mean): range 0-10 mm

  5. Efficacy as measured by time to pulmonary vein isolation.

    Time frame: Day 1

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

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

Secondary outcomes

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

    Time frame: Day 1

    Length of procedure time determined by time lapsed per report from start of procedure to end of procedure.

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

    Time frame: month six

    Percentage of subjects with atrial fibrillation on 5 day event monitor at 6 months post-intervention.

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

    Time frame: month 12

    Percentage of subjects with atrial fibrillation on 5 day event monitor at 12 months post-intervention.

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

    Time frame: End of study (12 months)

    Adverse events will include any unfavorable and unintended sign, symptom, or disease temporally associated with the procedure.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Northwell Health
  • The Methodist Hospital Research Institute

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 20, 2019
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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