Radiofrequency Ablation of Atrial Fibrillation Under Apnea

Atrial Fibrillation Clinical Trial

Official title:

Radiofrequency Ablation of Atrial Fibrillation Under Apnea

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04170894
• Other study ID #: 19-04020216
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: December 30, 2024
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Periods of Apnea
Periods of apnea throughout atrial fibrillation ablation.
• Control Arm - No Periods of Apnea
Standard of care atrial fibrillation ablation.

Locations

Country	Name	City	State
United States	Southside Hospital	Bay Shore	New York
United States	Houston Methodist Hospital	Houston	Texas
United States	North Shore Hospital	Manhasset	New York
United States	Lenox Hill Hospital	New York	New York
United States	New York Presbyterian Hospital - Weill Cornell Medicine	New York	New York
United States	Long Island Jewish Medical Center	Queens	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Northwell Health, The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Catheter Stability Metrics as measured by maximum and minimum contact force.	Maximum contact force: range between 0 and 60 grams	Day 1
Primary	Catheter Stability Metrics as measured by average contact force.	Average contact force: range between 0 and 60 grams	Day 1
Primary	Catheter Stability Metrics as measured by catheter displacement.	Catheter displacement (mean): range 0-10 mm	Day 1
Primary	Efficacy as measured by time to pulmonary vein isolation.	Time to pulmonary vein isolation (minutes): expected range 60 - 180 minutes	Day 1
Primary	Efficacy as measured by percentage of veins isolated after first pass.	Percentage of veins isolated after first pass: 0-100%	Day 1
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)