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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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
Are there results?
Not yet: the study is under way

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
Show all 11Show fewer
  • 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

Other trials in United States

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.

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 groups in NCT05434650
Study groupRoleWhat they receive
Treatment groupSingle 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.

  1. Proportion of subjects with freedom from AF recurrence post 90-day blanking period at 12 months

    AF recurrence is defined as:

    1. Documented AF/atrial flutter (AFL)/atrial tachycardia (AT) episodes of > 30 seconds duration following the blanking period
    2. Repeat ablation for AF/AFL/AT following the blanking period
    3. Cardioversion (electrical or pharmaceutical) for the treatment of AF following the blanking period
    4. 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

  2. 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)

  1. 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:

    1. Documented AF/atrial flutter (AFL)/atrial tachycardia (AT) episodes of > 30 seconds duration following the blanking period
    2. Repeat ablation for AF/AFL/AT following the blanking period
    3. Cardioversion (electrical or pharmaceutical) for the treatment of AF following the blanking period
    4. 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

  2. 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.

  1. First posted28 Jun 2022
  2. Study start21 Oct 2022
  3. Primary completion22 Oct 2024
  4. Study completion30 Nov 2026 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Arrhythmia and Atrium; Fibrillation, run by Abbott Medical Devices at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with freedom from AF recurrence post 90-day blanking period at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05434650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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