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Radiofrequency Ablation of Atrial Fibrillation Under Apnea

Primary Purpose

Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Periods of Apnea
Control Arm - No Periods of Apnea
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Radiofrequency Ablation, Ablation, Arrhythmia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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%.

Sites / Locations

  • Southside Hospital
  • North Shore Hospital
  • New York Presbyterian Hospital - Weill Cornell Medicine
  • Lenox Hill Hospital
  • Long Island Jewish Medical Center
  • Houston Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apnea

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
Catheter Stability Metrics as measured by maximum and minimum contact force.
Maximum contact force: range between 0 and 60 grams
Catheter Stability Metrics as measured by average contact force.
Average contact force: range between 0 and 60 grams
Catheter Stability Metrics as measured by catheter displacement.
Catheter displacement (mean): range 0-10 mm
Efficacy as measured by time to pulmonary vein isolation.
Time to pulmonary vein isolation (minutes): expected range 60 - 180 minutes
Efficacy as measured by percentage of veins isolated after first pass.
Percentage of veins isolated after first pass: 0-100%
Catheter Stability Metrics as measured by time to impedance drop.
Time to 5 ohm and 10 ohm impedance drop: range 1 to 60 seconds

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 18, 2019
Last Updated
September 13, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Northwell Health, The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04170894
Brief Title
Radiofrequency Ablation of Atrial Fibrillation Under Apnea
Official Title
Radiofrequency Ablation of Atrial Fibrillation Under Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Northwell Health, The Methodist Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Radiofrequency Ablation, Ablation, Arrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apnea
Arm Type
Experimental
Arm Description
Patients will undergo an atrial fibrillation ablation and will have induced periods of apnea throughout the procedure.
Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Periods of Apnea
Intervention Description
Periods of apnea throughout atrial fibrillation ablation.
Intervention Type
Other
Intervention Name(s)
Control Arm - No Periods of Apnea
Intervention Description
Standard of care atrial fibrillation ablation.
Primary Outcome Measure Information:
Title
Catheter Stability Metrics as measured by contact force variability.
Description
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.
Time Frame
Day 1
Title
Catheter Stability Metrics as measured by maximum and minimum contact force.
Description
Maximum contact force: range between 0 and 60 grams
Time Frame
Day 1
Title
Catheter Stability Metrics as measured by average contact force.
Description
Average contact force: range between 0 and 60 grams
Time Frame
Day 1
Title
Catheter Stability Metrics as measured by catheter displacement.
Description
Catheter displacement (mean): range 0-10 mm
Time Frame
Day 1
Title
Efficacy as measured by time to pulmonary vein isolation.
Description
Time to pulmonary vein isolation (minutes): expected range 60 - 180 minutes
Time Frame
Day 1
Title
Efficacy as measured by percentage of veins isolated after first pass.
Description
Percentage of veins isolated after first pass: 0-100%
Time Frame
Day 1
Title
Catheter Stability Metrics as measured by time to impedance drop.
Description
Time to 5 ohm and 10 ohm impedance drop: range 1 to 60 seconds
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Procedural time as measured by the length of time from start to end of procedure.
Description
Length of procedure time determined by time lapsed per report from start of procedure to end of procedure.
Time Frame
Day 1
Title
Clinical Outcomes as measured by recurrence of atrial fibrillation at six months post procedure.
Description
Percentage of subjects with atrial fibrillation on 5 day event monitor at 6 months post-intervention.
Time Frame
month six
Title
Clinical Outcomes as measured by recurrence of atrial fibrillation at 12 months post procedure.
Description
Percentage of subjects with atrial fibrillation on 5 day event monitor at 12 months post-intervention.
Time Frame
month 12
Title
Safety, as measured by number of subjects with at least one adverse event.
Description
Adverse events will include any unfavorable and unintended sign, symptom, or disease temporally associated with the procedure.
Time Frame
End of study (12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Cheung, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southside Hospital
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
North Shore Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York Presbyterian Hospital - Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Long Island Jewish Medical Center
City
Queens
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Radiofrequency Ablation of Atrial Fibrillation Under Apnea

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