Atrial ArrhythmiaNCT05434650
Abbott Atrial Fibrillation Post Approval Study
An observational study of Atrial Arrhythmia and Atrium; Fibrillation, run by Abbott Medical Devices at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Arrhythmia, Atrium; Fibrillation, Atrial Tachycardia
- What is being tested?
- electrophysiology study and ablation with an Abbott Ablation Catheter
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 20 sitesUnited States
- Study dates
- 21 Oct 2022to 30 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: This clinical investigation will enroll subjects of all genders who have drug refractory, symptomatic, persistent AF.
Who may be able to join
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
- 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:
- a 24-hour Holter within 180 days prior to consent/enrollment, showing continuous AF OR
- two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
- 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.
- Subject must have failed, intolerance, or contraindication to a Class I-IV AAD medication.
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Who cannot join
- Previously diagnosed continuous AF >12 months (longstanding persistent AF)
- 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
- Documented or known intracardiac thrombus on imaging
- History of atriotomy or ventriculotomy within 4 weeks prior to the initial procedure
- Patients with prosthetic valves
- Diagnosed atrial myxoma
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- Acute illness or active systemic infection or sepsis
- Patient is unlikely to survive the protocol follow up period of 36 months
- 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
- 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
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Northside Hospital
Atlanta, Georgia, 30342
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Heart Center Research, LLC.
Huntsville, Alabama, 35801
Arkansas Cardiology
Little Rock, Arkansas, 72205
St. Patrick Hospital
Missoula, Montana, 59802
Centennial Medical Center
Nashville, Tennessee, 37203
Ochsner Medical Center
New Orleans, Louisiana, 70121
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Oklahoma Heart Hospital South
Oklahoma City, Oklahoma, 73135
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Eisenhower Medical Center
Rancho Mirage, California, 92270
Sequoia Hospital
Redwood City, California, 94062
Chippenham Hospital
Richmond, Virginia, 23225
St. Marks Hospital
Salt Lake City, Utah, 84124
Methodist Hospital of San Antonio
San Antonio, Texas, 78229
Providence Hospital
Southfield, Michigan, 48075
North Mississippi Medical Center
Tupelo, Mississippi, 38801
About this study
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.
Read the 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.
- Conditions
- Atrial Arrhythmia, Atrium; Fibrillation, Atrial Tachycardia
- Being tested
- electrophysiology study and ablation with an Abbott Ablation Catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrophysiology study and ablation with an Abbott Ablation CatheterDevice
During the cardiac ablation procedure, an ablation catheter (a thin, flexible tube that can be threaded through the blood vessels to the heart) will deliver radiofrequency energy (a type of heat) to one or more areas in the upper left chamber of the heart that is causing the irregular heartbeat. The tip of the catheter will transmit energy to one or more small spots of heart tissue. This energy creates a small scar on the heart. This scar will block the electrical pathway that is causing the rapid heartbeat
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Single arm group to receive ablation Receives: Device: electrophysiology study and ablation with an Abbott Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with freedom from AF recurrence post 90-day blanking period at 12 months
AF recurrence is defined as:
- Documented AF/atrial flutter (AFL)/atrial tachycardia (AT) episodes of > 30 seconds duration following the blanking period
- Repeat ablation for AF/AFL/AT following the blanking period
- Cardioversion (electrical or pharmaceutical) for the treatment of AF following the blanking period
- A new Class I/III AAD or a previously failed Class I/III AAD at a dose greater than the highest historical dose for AF is needed following the blanking period
Measured: 12 months
Rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure
Device and/or index procedure-related SAEs are defined below:
- Atrio-esophageal fistula
- Cardiac tamponade/perforation
- Death
- Heart block
- Myocardial infarction (MI)
- Pericarditis
- Phrenic nerve injury resulting in diaphragmatic paralysis
- Vagal nerve injury/gastroparesis
- Pulmonary edema (respiratory insufficiency)
- Pulmonary vein stenosis
- Stroke/cerebrovascular accident (CVA)
- Thromboembolism
- Transient ischemic attack
- Vascular access complications (including major bleeding events3)
Measured: 7 days
Secondary outcomes (2)
the proportion of subjects with freedom from AF recurrence post 90-day blanking period at 24 months and 36 months
AF recurrence is defined as:
- Documented AF/atrial flutter (AFL)/atrial tachycardia (AT) episodes of > 30 seconds duration following the blanking period
- Repeat ablation for AF/AFL/AT following the blanking period
- Cardioversion (electrical or pharmaceutical) for the treatment of AF following the blanking period
- A new Class I/III AAD or a previously failed Class I/III AAD at a dose greater than the highest historical dose for AF is needed following the blanking period
Measured: 36 months
the rate of device and/or procedure-related SAEs from the index ablation procedure, descriptively evaluated at 12 months, 24 months, and 36 months
Device and/or index procedure-related SAEs are defined below:
- Atrioesophageal fistula
- Cardiac tamponade/perforation
- Death
- Heart block
- Myocardial infarction (MI)
- Pericarditis
- Phrenic nerve injury resulting in diaphragmatic paralysis
- Pneumothorax
- Pulmonary edema (respiratory insufficiency)
- Pulmonary vein stenosis
- Stroke/cerebrovascular accident (CVA)
- Thromboembolism
- Transient ischemic attack
- Vascular access complications (including major bleeding events)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start21 Oct 2022
- Primary completion22 Oct 2024
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Ruffner, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434650
- Sponsor's protocol ID
- ABT-CIP-10436
- Status last verified
- Nov 2025
- First submitted
- 22 Jun 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided