PFA Ablation and LAAC ProceduresNCT07041125
Concomitant LAAC/AF Ablation (Watchman FLX Pro)
An observational study of PFA Ablation and LAAC Procedures, run by Heart Rhythm Clinical and Research Solutions, LLC at 15 sites in United States.
Trial summary
This sub-study is a prospective/retrospective, non-randomized, observational, comparative cohorts study, embedded in and expanding on the infrastructure of a real-world AF ablation registry DISRUPT-AF (NCT06335082). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PFA Ablation and LAAC Procedures
- What is being tested?
- Watchman FLX™ Pro device.
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Jun 2025to 30 Jun 2026
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device
Inclusion Criteria: All inclusion criteria of the main DISRUPT-AF registry will apply. In addition, patients included in this sub study must meet the additional inclusion criteria below:
- Patients who are determined by physicians to be eligible for LAAC
- Patients whose LAAC with Watchman FLX Pro procedures are performed concomitant following AF ablation procedure
- Willing and able to provide additional informed consent to the sub-study (unless waiver of consent is obtained)
Exclusion Criteria: All exclusion criteria of the main DISRUPT-AF registry will apply. In addition, patients included in this sub study have the additional exclusion criteria below:
-Patients who are participating in other DISRUPT-AF sub-studies
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Arrhythmia Institute at Grandview
Birmingham, Alabama, 35243
Arrhythmia Center of South Florida
Delray Beach, Florida, 33484
The Heart Rhythm Center of Mississippi
Gulfport, Mississippi, 39502
Ascension St Vincent -Indianapolis Ascension Health
Indianapolis, Indiana, 46184
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Ascension St. Vincent's Jacksonville
Jacksonville, Florida, 32204
South Denver Cardiology Associates
Littleton, Colorado, 80120
Norton Heart & Vascular Institute
Louisville, Kentucky, 40205
HCA Research Institute- Mercy Hospital
Miami, Florida, 37203
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Chippenham Hospital)
Richmond, Virginia, 23225
St, Mark's Hospital
Salt Lake City, Utah, 84124
California Pacific Medical Center Sutter Health
San Francisco, California, 94109
About this study
Official title: Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)
This sub-study is a prospective/retrospective, non-randomized, observational, comparative cohorts study, embedded in and expanding on the infrastructure of a real-world AF ablation registry DISRUPT-AF (NCT06335082).
Read the detailed description
The prospective arm of the sub-study is intended to enroll 120 subjects indicated for PFA and Watchman in up to 20 US sites within the framework of the DISRUPT-AF registry. Subjects will be screened for eligibility to participate in concomitant PFA ablation for AF and LAAC by Watchman FLX Pro device in a single procedure. Both PVI and LAAC procedures are performed per SOC. In general, percutaneous catheterization will be initially established using FARADRIVE™ steerable sheath for ablation treatment of AF using the FARAWAVE Catheter per instruction for use (IFU) of the device and operator's standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. After AF ablation, the FARAWAVE Catheter will be withdrawn. The FARADRIVE™ steerable sheath will be replaced with Watchman FLX deployment sheath. Deployment of Watchman FLX Pro device to LAA to achieve LAAC will follow the standard practice of the care and IFU of the device. Patients will be followed up at 45-90 days for LAAC implant assessment and at 3, 6, and 12 months for arrhythmia recurrence assessment
- Conditions
- PFA Ablation and LAAC Procedures
- Being tested
- Watchman FLX™ Pro device.
- Keywords
- AF ablation, FARADRIVE™, Watchman FLX Pro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watchman FLX™ Pro device.Device
Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device.
| Study group | Role | What they receive |
|---|---|---|
| Combining LAAC and PFA ablation procedures | AF ablation and LAAC procedures are performed per operators' standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. Both AF ablation and LAAC procedures may be performed with ICE or TEE. Assessment of LAAC peri-device leaks and device-related thrombi at 45-90 days may be performed with TEE or cardiac computed tomography angiography (CCTA). Receives: Device: Watchman FLX™ Pro device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of events between the time of implant and within 7 days following the procedure
AF ablation safety will be compared between the concomitant procedures and standalone AF ablation cohort. and LAAC procedure safety will be compared between the concomitant procedures and standalone LAAC cohort.
Measured: 12 months
Secondary outcomes (1)
LAAC success and late-onset safety
45-90 days leaks around LAAC device, 45-90 days device-related thrombus and
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jun 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PFA Ablation and LAAC ProceduresStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041125
- Sponsor's protocol ID
- ALIGN-AF
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)
- ClinicalTrials.gov ID
- NCT07041125
- Acronym / sponsor ID
- ALIGN-AF
- Conditions
- PFA Ablation and LAAC Procedures
- Keywords
- AF ablation, FARADRIVE™, Watchman FLX Pro
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLCUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This sub-study is a prospective/retrospective, non-randomized, observational, comparative cohorts study, embedded in and expanding on the infrastructure of a real-world AF ablation registry DISRUPT-AF (NCT06335082).
Detailed description
The prospective arm of the sub-study is intended to enroll 120 subjects indicated for PFA and Watchman in up to 20 US sites within the framework of the DISRUPT-AF registry. Subjects will be screened for eligibility to participate in concomitant PFA ablation for AF and LAAC by Watchman FLX Pro device in a single procedure. Both PVI and LAAC procedures are performed per SOC. In general, percutaneous catheterization will be initially established using FARADRIVE™ steerable sheath for ablation treatment of AF using the FARAWAVE Catheter per instruction for use (IFU) of the device and operator's standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. After AF ablation, the FARAWAVE Catheter will be withdrawn. The FARADRIVE™ steerable sheath will be replaced with Watchman FLX deployment sheath. Deployment of Watchman FLX Pro device to LAA to achieve LAAC will follow the standard practice of the care and IFU of the device. Patients will be followed up at 45-90 days for LAAC implant assessment and at 3, 6, and 12 months for arrhythmia recurrence assessment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combining LAAC and PFA ablation procedures | – | Device: Watchman FLX™ Pro device.AF ablation and LAAC procedures are performed per operators' standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. Both AF ablation and LAAC procedures may be performed with ICE or TEE. Assessment of LAAC peri-device leaks and device-related thrombi at 45-90 days may be performed with TEE or cardiac computed tomography angiography (CCTA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watchman FLX™ Pro device.Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device. | Device | Combining LAAC and PFA ablation procedures |
Primary outcome
The occurrence of events between the time of implant and within 7 days following the procedure
Time frame: 12 months
AF ablation safety will be compared between the concomitant procedures and standalone AF ablation cohort. and LAAC procedure safety will be compared between the concomitant procedures and standalone LAAC cohort.
1 secondary outcome
LAAC success and late-onset safety
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
Related trials for PFA Ablation and LAAC Procedures
Active, not recruitingObservational study
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Concomitant Procedures, Atrial Fibrillation
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Enrolling by invitation
Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Symptoms and High Stroke Risk
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, PFA Ablation and LAAC Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PFA Ablation and LAAC Procedures, run by Heart Rhythm Clinical and Research Solutions, LLC at 15 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?
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: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The occurrence of events between the time of implant and within 7 days following the procedure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.