Endocardial Mapping With the CoreMap EP Mapping System

Official title

Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol

Overview

This is a global, multi-site, prospective, feasibility study.

Detailed description

The INvENI Study consists of three phases:

Phase 1, the goal is to collect and analyze high fidelity endocardial electrograms (EGMs) in patients with persistent AF (PerAF) and long-standing persistent AF and to demonstrate safety.

Phase 2, the goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate safety and effectiveness of the CoreMap EP Mapping System in patients with PerAF and long-standing persistent AF.

Phase 3, the goal is to evaluate the safety and effectiveness of the CoreMap EP Mapping System's ability to identify spatially constrained AF drivers and guide ablation therapy in PerAF patients with no history of prior AF ablation. This phase aims to demonstrate safety and effectiveness compared to a control arm.

Interventions

• Device CoreMap EP Mapping System Mapping
  Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
• Device CoreMap EP Mapping System Map-Guided Ablation
  Initial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System.

Primary outcome measures

• Phases 1 and Phase 2 Primary Endpoint: [Time frame: 7 days]
• Phase 2 and Phase 3 Primary Effectiveness Endpoint: [Time frame: 6 and 12 months]

Secondary outcome measures (3)

• Phase 1 Secondary Endpoint: [Time frame: perioperatively/periprocedurally]
• Phase 2 Secondary Endpoints: [Time frame: perioperatively/periprocedurally]
• Phase 3 Secondary Endpoints: [Time frame: perioperatively/periprocedurally]

Eligibility criteria

Inclusion criteria

• Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2)
• Subject has PerAF with no history of prior AF ablation therapy (Phase 3)
• Subject is 18 to 80 years of age
• Subject has presence of AF-related symptoms and is scheduled for clinically indicated standard of care AF ablation to manage PerAF (Phase 2 or 3) or long-standing PerAF (Phase 2)
• Subject is able to provide written informed consent
• Subject is able and willing to complete all study procedures

Exclusion criteria

• Any of the following within three months of enrollment:

• Myocardial infarction (MI)
• Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
• Confirmed thrombus on imaging
• Any of the following within six months of enrollment:

• Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
• Thromboembolic event (stroke)
• Any of the following cardiac conditions:

• New York Heart Association (NYHA) IV
• Left ventricular ejection fraction (LVEF) < 30%
• Left atrial diameter >55mm (anterioposterior) (Phase 3)
• Carotid stenting or endarterectomy
• Atrial or ventricular septal closure or left atrial appendage closure
• Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.
• Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
• Unstable angina
• Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
• Moderate to severe mitral valve stenosis or other severe valvular disease
• Any blood clotting or bleeding abnormalities
• Contraindication to systemic anticoagulation
• AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
• Body mass index (BMI) > 40 kg/m2
• Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
• Renal failure requiring dialysis or transplant
• Acute illness, active systemic infection, or sepsis
• Active drug or alcohol dependency
• Hypertrophic cardiomyopathy or cardiac amyloidosis
• Cor pulmonale
• Any contra-indication that may extend procedure time, at the discretion of the operator
• Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
• Subject considered part of vulnerable population
• Life expectancy less than one year
• Employee of the study site or Sponsor
• Subjects who are currently enrolled in another study that would directly interfere with this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 3 centers

• NCH Downtown Baker Hospital — Naples
• University of Vermont Medical Center — Burlington
• Virginia Commonwealth University (VCU) — Richmond

Czechia · 1 center

• Na Homolce Hospital — Praha Klanovice

Identifiers

NCT: NCT06529978 · CD001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗