- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04904354
AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation (AcQForce AF)
November 9, 2023 updated by: Acutus Medical
AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation (AcQForce AF)
The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study designed to demonstrate the safety and efficacy of the AcQBlate Force Sensing System in the ablation treatment of symptomatic, drug-refractory atrial fibrillation in two subject cohorts: paroxysmal atrial fibrillation, and persistent atrial fibrillation.
Data will be used to support pre-market approval applications (PMAs).
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female between the ages of 18 to 80 years at time of consent
- Clinically indicated and scheduled for a de novo catheter ablation of symptomatic PAF or PerAF.
- Refractory to Antiarrhythmic Drug (AAD) treatment
- Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.
Exclusion Criteria:
- In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications or sepsis.
Continuous episodes of AF Duration:
- PAF: AF duration lasting longer than 7 days
- Persistent AF: AF duration lasting longer than 12-months.
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- An implantable cardiac defibrillator (ICD) or pacemaker.
- Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
Structural heart disease or cardiac history as described below:
- Left ventricular ejection fraction (LVEF) < 40% based on transthoracic echocardiogram (TTE) within the previous 180-days.
- Left atrial size > 55 mm based on transthoracic echocardiogram (TTE) measurement of the anteroposterior diameter, parasternal long-axis view in M Mode and performed within the previous 180-days.
- Evidence of heart failure (NYHA Class III or IV)
- Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for coronary artery bypass).
- Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
- Coronary artery bypass graft (CABG) within the last 180-days or coronary angioplasty (PTCA) procedure within the last 90-days.
- Unstable angina or ongoing myocardial ischemia.
- Myocardial infarction within the previous 180-days (sub-endocardial infarct within previous 90-days).
- Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic pressure > 140 mm Hg) recorded within the last 30 days.
- Moderate or severe valvular heart disease (stenosis or regurgitation).
- Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
- Presence of a left atrial appendage occlusion device.
- Previous PV stenting or evidence of PV stenosis.
- Presence of Left Atrial Thrombus
- Body Mass Index (BMI) > 42 kg/m2
- Estimated Glomerular Filtration Rate (eGFR) of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
- History of blood clotting or bleeding disease.
- ANY prior history of documented cerebral infarct, or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
- History of chronic obstructive pulmonary disease (COPD) requiring oral or IV steroid use in the previous 12-months.
- History of obstructive sleep apnea not currently being treated.
- Pregnant or lactating (current or anticipated during study follow-up).
- Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study.
- Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paroxysmal atrial fibrillation
Subjects schedule for a de novo ablation of paroxysmal atrial fibrillation
|
Catheter ablation of accessible pulmonary veins with the endpoint of creating electrical isolation for each targeted vein.
Additional left and right atrial targets may be ablated as clinically indicated.
|
Experimental: Persistent atrial fibrillation
Subjects schedule for a de novo ablation of persistent atrial fibrillation
|
Catheter ablation of accessible pulmonary veins with the endpoint of creating electrical isolation for each targeted vein.
Additional left and right atrial targets may be ablated as clinically indicated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period
Time Frame: 12 months
|
Freedom from recurrence of atrial arrhythmias
|
12 months
|
Subjects who are free from device and/or procedure related Major Adverse Events (MAEs)
Time Frame: 12 months
|
Subjects free from a composite list of pre-specified procedure/device related Major Adverse Events (MAEs)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recording of all serious adverse events/device effects
Time Frame: 12 months
|
Recording of all serious adverse events/device effects
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2023
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
May 24, 2021
First Submitted That Met QC Criteria
May 24, 2021
First Posted (Actual)
May 27, 2021
Study Record Updates
Last Update Posted (Estimated)
November 13, 2023
Last Update Submitted That Met QC Criteria
November 9, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLP-16
- CLP-16-EU (Other Identifier: Acutus Medical, Inc.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Paroxysmal Atrial Fibrillation
-
Medtronic Cardiac Rhythm and Heart FailureCompletedParoxysmal Atrial Fibrillation (PAF)United States, Canada
-
Biosense Webster, Inc.Active, not recruitingRefractory Paroxysmal Atrial FibrillationChina
-
Boston Scientific CorporationCompletedParoxysmal Atrial Fibrillation (PAF)United States, Spain, Germany, Australia, United Kingdom, Sweden, Czechia, France, Portugal
-
Biosense Webster, Inc.RecruitingDrug Refractory Paroxysmal Atrial FibrillationUnited States
-
Hospital Clinic of BarcelonaCompletedDrug-refractory Paroxysmal Atrial FibrillationSpain
-
Charite University, Berlin, GermanyGerman Federal Ministry of Education and ResearchTerminatedSymptomatic Paroxysmal Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Biosense Webster, Inc.CompletedDrug Refractory Symptomatic Paroxysmal Atrial FibrillationUnited States
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic Atrial Fibrillation SolutionsCompletedSymptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart DiseasesNetherlands, Australia, France, Norway, Germany, Croatia, Italy, Argentina, Belgium
-
Beijing Anzhen HospitalJohnson & Johnson; Heart Health Research CenterNot yet recruitingParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation
Clinical Trials on AcQBlate® Force Sensing Ablation System
-
Acutus MedicalCompletedTypical Atrial FlutterBelgium, United States, United Kingdom
-
Acutus MedicalNot yet recruitingParoxysmal Atrial Fibrillation | Persistent Atrial Fibrillation
-
Acutus MedicalCompletedTypical Atrial FlutterBelgium, United Kingdom
-
Acutus MedicalWithdrawn
-
Erasmus Medical CenterUnknownTachycardia, Supraventricular | Tachycardia; Paroxysmal, SupraventricularNetherlands
-
Ningbo No. 1 HospitalCompletedParoxysmal Supraventricular TachycardiaChina
-
Shanghai MicroPort EP MedTech Co., Ltd.Active, not recruitingParoxysmal Supraventricular TachycardiaChina
-
Abbott Medical DevicesEndosenseCompletedAtrial Fibrillation | Tachycardia, Supraventricular
-
Kardium Inc.CompletedAtrial FibrillationGermany, Switzerland
-
AtriCure, Inc.RecruitingPostural Tachycardia Syndrome | Inappropriate Sinus TachycardiaBelgium