Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm

NCT05077670 | Unknown FDA Device

• 1 other identifier: Hybrid-AFMAP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is twofold, first we aim to identify rotors in atrial fibrillation (AF) and analyze their relationship with the left atrium-left atrial appendage (LA-LAA) connections. Secondly, we will analyze the areas harboring rotors in SR to define the characteristics that describe the presence of rotors.

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial fibrillation; Catheter ablation; Rotors

Outcome Measures

Primary Outcomes (1)

• CartoFinder and COHERENT tools utility assessment

  To evaluate the utility of CartoFinder and COHERENT tools in the identification of the mechanisms that maintain atrial fibrillation.

  2 years

Secondary Outcomes (1)

• Atrial fibrillation driver location analysis

  2 years

Study Arms (1)

Study group

* LAA + LA Map in AF * Identify LAA connections and detect rotors with CartoFinder * Electrical cardioversion. Sinus rhythm restoration * Pacing from the coronary sinus at 300 and 600ms periods * Analyze COHERENT activation maps in sinus rhythm * Ablation as suggested by current clinical guidelines and the characteristics of the patient

Procedure: Pulmonary vein electrical isolation; Device: Atrial substrate mapping

Interventions

Pulmonary vein electrical isolation PROCEDURE

Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy.

Also known as: Pulmonary veins ablation

Study group

Atrial substrate mapping DEVICE

Electro-anatomical maps will be performed with CARTO navigation system with multi-electrode catheters.

Also known as: Electro-anatomical mapping

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include 50 patients. No statistical considerations were made to determine the sample size of this study.

You may qualify if:

• Persistent atrial fibrillation
• The patient has signed the informed consent form
• No LAA previous ablation procedure
• No valvular disease
• LVEF ≥ 35% prior to recruitment
• Age ≥ 18 years

You may not qualify if:

• LVEF \< 35 %
• Hyperthyroidism or hypothyroidism
• Mental or physical illness incapacitation
• Planned cardiac procedure
• Non-controlled hypertension
• Terminal renal failure or dialysis
• Class IV of the NYHA
• Age ≥ 75 years
• Life expectancy \< 2 years
• Atrioventricular block
• Pregnancy

Sponsors & Collaborators

• Fundacion para la Innovacion en Biomedicina (FIBMED): lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ángel Arenal, MD, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• Gonzalo R Ríos-Muñoz, MSc, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)