Clinical trial NCT05434650: Abbott Atrial Fibrillation Post Approval Study
Official title: Abbott Atrial Fibrillation Post Approval Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Arrhythmia
Atrium; Fibrillation
Atrial Tachycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This clinical investigation will enroll subjects of all genders who have drug refractory, symptomatic, persistent AF.

Brief summary: This post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g. TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)) for the treatment of AF.

Detailed description: This post-approval study is a prospective, non-randomized, single arm, multicenter, observational study to evaluate the continued safety and effectiveness of AF RF technologies, including the TactiCath SE. The primary effectiveness endpoint will be the proportion of subjects with freedom from AF recurrence after the initial catheter ablation procedure through 12 months of follow-up (includes a 90-day blanking period). Secondary effectiveness endpoints will be the proportion of subjects with freedom from AF recurrence after the initial catheter ablation procedure through 24 and 36 months of follow-up (includes a 90-day blanking period). The acute primary safety endpoint will be the rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure utilizing the study catheter. The secondary, long-term safety endpoint will be the rate of device and/or procedure-related SAEs from the index ablation procedure. An independent Clinical Event Committee (CEC) will review all Adverse Device Effects (ADEs) and SAEs and will adjudicate causality relative to the primary safety endpoints.

Eligibility criteria: Inclusion Criteria:

1. Subject must provide written informed consent prior to any clinical investigation-related procedure.
2. Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year that is documented by a physician's note AND one of the following:

   1. a 24-hour Holter within 180 days prior to consent/enrollment, showing continuous AF OR
   2. two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:

   i. that are taken at least 7 days apart but less than 12 months apart. ii. If electrocardiograms are more than 12 months apart, there must be one or more SR recordings in between or within 12 months prior to consent/enrollment NOTE: The most recent ECG must be within 180 days of consent/enrollment. Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
3. Subject must have failed, intolerance, or contraindication to a Class I-IV AAD medication.
4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

1. Previously diagnosed continuous AF \>12 months (longstanding persistent AF)
2. Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar
3. Documented or known intracardiac thrombus on imaging
4. History of atriotomy or ventriculotomy within 4 weeks prior to the initial procedure
5. Patients with prosthetic valves
6. Diagnosed atrial myxoma
7. Acute illness or active systemic infection or sepsis
8. Patient is unlikely to survive the protocol follow up period of 36 months
9. Presence of other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
10. Enrollment in an investigational study evaluating another device, biologic, or drug that may interfere with this clinical investigation at the time of the initial procedure or within 30 days prior to the initial procedure
11. Investigator deems at the time of screening for inclusion in the study that the patient's treatment plan does not or likely will not include use of the study catheter

Primary outcomes:
measure: Proportion of subjects with freedom from AF recurrence post 90-day blanking period at 12 months
timeFrame: 12 months
measure: Rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure
timeFrame: 7 days
Secondary outcomes:
measure: the proportion of subjects with freedom from AF recurrence post 90-day blanking period at 24 months and 36 months
timeFrame: 36 months
measure: the rate of device and/or procedure-related SAEs from the index ablation procedure, descriptively evaluated at 12 months, 24 months, and 36 months
timeFrame: 36 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC.
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Cardiology
state: Arkansas
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital South
state: Oklahoma
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Methodist Hospital of San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: St. Marks Hospital
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Chippenham Hospital
state: Virginia
Study officials:
affiliation: Abbott
name: Kristin Ruffner
role: STUDY_DIRECTOR
References: