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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Periods of Apnea; Other: Control Arm - No Periods of Apnea

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bay Shore, New York, United States, 11706
      • Southside Hospital
    • Manhasset, New York, United States, 11030
      • North Shore Hospital
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital - Weill Cornell Medicine
    • Queens, New York, United States, 11040
      • Long Island Jewish Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apnea; Patients will undergo an atrial fibrillation ablation and will have induced periods of apnea throughout the procedure.	Other: Periods of Apnea; Periods of apnea throughout atrial fibrillation ablation.
Active Comparator: 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.	Other: Control Arm - No Periods of Apnea; Standard of care atrial fibrillation ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time as measured by the length of time from start to end of procedure.	Length of procedure time determined by time lapsed per report from start of procedure to end of procedure.	Day 1
Clinical Outcomes as measured by recurrence of atrial fibrillation at six months post procedure.	Percentage of subjects with atrial fibrillation on 5 day event monitor at 6 months post-intervention.	month six
Clinical Outcomes as measured by recurrence of atrial fibrillation at 12 months post procedure.	Percentage of subjects with atrial fibrillation on 5 day event monitor at 12 months post-intervention.	month 12
Safety, as measured by number of subjects with at least one adverse event.	Adverse events will include any unfavorable and unintended sign, symptom, or disease temporally associated with the procedure.	End of study (12 months)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Northwell Health; The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Jim Cheung, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Arrhythmia; Ablation; Radiofrequency Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 19-04020216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No