AcQBlate Force Confirmatory Study for Atrial Arrhythmias

NCT04429464 | Withdrawn FDA Device

• 1 other identifier: CLP-14
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)

Conditions

Atrial Arrhythmias

Keywords

ablation; atrial arrhythmia

Outcome Measures

Primary Outcomes (2)

• Subjects that demonstrate electrical isolation of the intended ablation

  The Primary Endpoint for Performance is an analysis of the proportion of subjects that demonstrate electrical isolation (block) of the intended ablation targets.

  At the end of their ablation procedure

• Proportion of subjects who are free from device/procedure related Major Adverse Events

  The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 30-days.

  Through 30-days post procedure

Secondary Outcomes (2)

• Subjects with freedom from an atrial arrhythmia

  30-days post index procedure

• Analysis of all identified SAEs, SADEs, and UADEs.

  Through 30-days post procedure

Study Arms (1)

Non-randomized

EXPERIMENTAL

All subjects will be treated using the Acutus Medical's AcQBlate Force Sensing Ablation Catheter in combination with the Qubic Force Sensing Module (AcQBlate Force Sensing System) to treat their arrhythmia.

Device: AcQBlate Force Sensing Ablation Catheter

Interventions

AcQBlate Force Sensing Ablation Catheter DEVICE

Confirmation that the AcQBlate Force System is safe and effective for the treatment of atrial arrhythmias

Non-randomized

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between the ages of 18 to 80 years at time of consent.
• Clinically indicated and scheduled for a de novo or repeat catheter ablation of PAF or PerAF
• Willing and able to provide written informed consent to to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.

You may not qualify if:

• In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications or sepsis
• Continuous AF \> 12-months (long-standing persistent AF)
• Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
• An implanted pacemaker or Implantable Cardiac Defibrillator (ICD).
• Structural heart disease or cardiac history as described below:
• Left ventricular ejection fraction (LVEF) \< 35% based on transthoracic echocardiogram (TTE) within the previous 180-days.
• Left atrial size \> 55 mm based on TTE 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) or coronary angioplasty (PTCA) procedure within the last 90-days.
• Unstable angina or ongoing myocardial ischemia.
• Severe uncontrolled systemic hypertension (systolic pressure \> 240 mm Hg, diastolic pressure \> 140 mm Hg recorded within the last 30-days.
• Moderate or severe tricuspid stenosis or regurgitation.
• Moderate or severe mitral stenosis or regurgitation.

Sponsors & Collaborators

• Acutus Medical: lead

Study Sites (1)

Na Homolce Hospital

Prague, 150 30, Czechia

Location

Study Officials

• Petr Neuzil, MD

  Na Homolce Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo or repeat left-sided atrial ablation for symptomatic paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PerAF).

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: October 1, 2020
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

CZ (1)