Atrial Fibrillation (AF)CLEARNCT07523620
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
A study testing PVI Ablation and Left Atrial Appendage Occluder Implant in people with Atrial Fibrillation (AF) and Paroxysmal AF, run by Abbott Medical Devices at 16 sites in 10 countries.
Trial summary
The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Paroxysmal AF, Persistent Atrial Fibrillation
- What is being tested?
- PVI Ablation and Left Atrial Appendage Occluder Implant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 16 sitesin 10 countries
- Study dates
- 31 Mar 2026to 28 Feb 2028
- Phase
- Interventional
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
- 18 years of age or older, or the age of legal consent
- CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men
- Able to stop anticoagulation by 90 days post index procedure
- Able to adhere to the protocol defined post-concomitant procedure pharmacologic regimen of OAC for at least 60 days followed by SAPT
- Plans to undergo a catheter ablation procedure including PVI due to symptomatic, recurrent, drug-refractory PAF or PersAF
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- Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
- Paroxysmal:
- Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 12 months prior to enrollment AND
- One electrocardiographically documented PAF episode within 12 months prior to enrollment.
- Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
- Physician's note, AND either
- 24-hour Holter within 180 days prior to 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
- If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
- The most recent electrocardiogram must be within 180 days of enrollment.
- NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.
Who cannot join
- Known contraindication or allergy to NOACs or aspirin, preventing use of the drugs post-procedure
- Required to take P2Y12 platelet inhibitor after the study procedure (e.g., due to percutaneous coronary intervention)
- Patients with heart prosthetic valves
- Patient implanted with an inferior vena cava filter
- Patients with left ventricular ejection fraction ≤30%
- Patients with NYHA Class IV heart failure
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- Patients who have undergone any invasive intervention or surgery within 30 days prior to the index procedure (diagnostic catheterization is not within scope, however, percutaneous coronary intervention is within scope)
- Patients who have experienced stroke or transient ischemic attack within 90 days prior to study procedure
- Patients who have had previous attempt at LAA surgical or epicardial intervention (e.g., stapling, suturing, ligation, epicardial LAA management device)
- Patients previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
- Patients with arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures within 90 days prior to the study procedure
- Patients unable to receive heparin or an acceptable alternative to achieve adequate intra-procedural anticoagulation
- Patients with a stent, constriction, or stenosis in a pulmonary vein
- Patients with severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
- Patients with severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or on chronic dialysis
- Patients with severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- Patients with hypertrophic cardiomyopathy (maximal LV wall thickness ≥ 15 mm in the absence of abnormal loading conditions such as hypertension or aortic stenosis)
Trial locations and contacts
16 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 10 countries
Germany3 sites, 3 recruiting
- Recruiting
Deutsches Herzzentrum der Charite
Berlin, State of Berlin, 13353
- Recruiting
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse, 60389
- Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schlesw, 23538
Italy2 sites, 2 recruiting
- Recruiting
Centro Cardiologico Monzino
Milan, Italy, 20138
- Recruiting
ASST Grande Ospedale Metropolitano
Milan, Lombard, 20162
Poland2 sites, 2 recruiting
- Recruiting
Centralny Szpital Kliniczny Uniwersytetu
Lodz
- Not yet recruiting
Slaskie Centrum Chorob Serca
Zabrze, Silesian Voivodeship, 41-800
Spain2 sites, 2 recruiting
- Recruiting
Hospital de la Santa Creu I Sant Pau
Barcelona, Catalon, 08025
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Royal Sussex County Hospital
Brighton
- Not yet recruiting
John Radcliffe Hospital
Oxford
Czechia1 site, 1 recruiting
- Recruiting
Motol and Homolka University Hospital
Prague, Czech Republic, 1500
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Copenha, 2100
Ireland1 site, 1 recruiting
- Recruiting
Mater Private Hospital
Dublin, Dublin, Dublin 7
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius, Dzukija, 08406
About this study
The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.
Read the detailed description
This clinical investigation is intended to evaluate the safety and feasibility of Abbott's Volt™ Pulsed Field Ablation (PFA) System (Volt PFA System) and Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients with non-valvular atrial fibrillation who are indicated for both atrial fibrillation (AF) ablation and LAA occlusion (LAAO)
- Being tested
- PVI Ablation, Left Atrial Appendage Occluder Implant
- Keywords
- Left Atrial Appendage, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI AblationProcedure or surgery
PVI Ablation with Pulsed Field Ablation
Left Atrial Appendage Occluder ImplantDevice
Left atrial appendage occluder implant
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Concomitant procedure utilizing the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO implant. Receives: Procedure: PVI Ablation; Device: Left Atrial Appendage Occluder Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
LAA occlusion success determined by peri-device flow ≤5mm
The primary effectiveness outcome is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on Doppler color flow TEE/TOE at the 3-month follow-up visit as assessed by an independent core laboratory
Measured: From treatment through 3-month follow-up vists
Occurrence of specific adverse events between time of implant and 7 days post-procedure or hospital discharge, whichever was later
The primary safety outcome is defined as occurrence of one of the following between the time of implant and ≤7 days post-procedure or hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device/procedure related complications requiring open cardiac surgery or major endovascular intervention
- Includes pseudoaneurysm repair or AV fistula repair
- Excludes percutaneous drainage of PE, snaring of embolized devices, thrombin injection or nonsurgical treatment of access site complications
Measured: From implant of LAAO through ≤7 days post-procedure or hospital discharge, whichever is later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start31 Mar 2026
- Primary completion31 May 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523620
- Sponsor's protocol ID
- ABT-CIP-10617
- Acronym
- CLEAR
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes