Clinical trial NCT04170894: Radiofrequency Ablation of Atrial Fibrillation Under Apnea
Official title: Radiofrequency Ablation of Atrial Fibrillation Under Apnea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Radiofrequency Ablation
Ablation
Arrhythmia
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Northwell Health
name: The Methodist Hospital Research Institute
First posted: 2019-11-20
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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%.

Primary outcomes:
measure: Catheter Stability Metrics as measured by contact force variability.
timeFrame: Day 1
measure: Catheter Stability Metrics as measured by maximum and minimum contact force.
timeFrame: Day 1
measure: Catheter Stability Metrics as measured by average contact force.
timeFrame: Day 1
measure: Catheter Stability Metrics as measured by catheter displacement.
timeFrame: Day 1
measure: Efficacy as measured by time to pulmonary vein isolation.
timeFrame: Day 1
measure: Efficacy as measured by percentage of veins isolated after first pass.
timeFrame: Day 1
measure: Catheter Stability Metrics as measured by time to impedance drop.
timeFrame: Day 1
Secondary outcomes:
measure: Procedural time as measured by the length of time from start to end of procedure.
timeFrame: Day 1
measure: Clinical Outcomes as measured by recurrence of atrial fibrillation at six months post procedure.
timeFrame: month six
measure: Clinical Outcomes as measured by recurrence of atrial fibrillation at 12 months post procedure.
timeFrame: month 12
measure: Safety, as measured by number of subjects with at least one adverse event.
timeFrame: End of study (12 months)
Other outcomes:
Locations:
city: Bay Shore
country: United States
facility: Southside Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Queens
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jim Cheung, MD
role: PRINCIPAL_INVESTIGATOR
References: