ISOLATION 2.0: a Multicenter Clinical Care and Research Platform

NCT05381805 | Not Yet Recruiting DMC

• 1 other identifier: NL80761.068.22
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Treatment recommendations and guidelines for patients with atrial fibrillation (AF) are continuously changing. The role of catheter ablation in the treatment of AF increases and the techniques of the procedures are improving unceasingly. Responding to and evaluating the effect of these changes requires careful examination of this patient population and procedure outcomes. The aim is to create a clinical characterization platform for patients scheduled for AF ablations with the purpose to optimize health care processes and related translational research.

Conditions

Atrial Fibrillation

Keywords

Ablation; Pulmonary Vein Isolation

Outcome Measures

Primary Outcomes (1)

• Ablation success

  Freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted.

  12 months

Secondary Outcomes (16)

• Time to recurrence of AF or other atrial arrhythmia after the blanking period.

  3 to 24 months

• Early recurrences of AF or other atrial arrhythmia

  0 to 3 months

• Number of participants with disease progression to persistent or permanent AF.

  0 to 24 months

• Use of antiarrhythmic drugs (AADs) one year after ablation.

  0 to 24 months

• Interleukin 6 (IL-6) level

  0 to 24 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from two hospitals in the Netherlands with documented AF, referred for AF ablation.

You may qualify if:

• years of age or older;
• Documented atrial fibrillation;
• Referred for any type of AF ablation: catheter ablation, stand-alone surgical AF ablation, surgical AF ablation concomitant with cardiac surgery, hybrid AF ablation, or redo AF ablation;
• Able and willing to provide written informed consent.

You may not qualify if:

• Conditions preventing the patient from adhering from the study protocol;
• Emergency procedures.
• A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG-imaging is asked:
• Severe allergic reaction against contrast agents used in the CT- or MRI-protocol
• Severe allergic reaction against body surface electrodes
• A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked:
• Status after esophageal or gastric surgery
• A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for Cardiovascular Magnetic Resonance (ISOLATION CMR) is asked:
• Contraindication to MRI
• A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (COMBAT-AF) is asked:
• Prior catheter or surgical AF ablation.
• Chronic obstructive pulmonary disease (COPD) Gold 11, 111, or IV;
• Heart failure, currently in New York Heart Association (NYHA) class Ill or IV;
• Any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Maastricht University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for analysis of circulating biomarkers of AF Possible biopts of the Left atrium in a subgroup of patients

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Kevin Vernooy, MD. PhD

  Maastricht UMC+ & Radboudumc

  PRINCIPAL INVESTIGATOR

• Dominik Linz, MD, PhD

  Maastricht UMC+ & Radboudumc & University of Adelaide and Royal Adelaide Hospital & University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Ulrich Schotten, MD, PhD

  Maastricht University & Cardiovascular Research Institute Maastricht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zarina Habibi, MD

CONTACT

+31-43-3881200; ablatie.onderzoek@gmail.com

Dominique Verhaert, MD

CONTACT

ablatie.onderzoek@gmail.com

Study Design

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

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: May 19, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 19, 2022

Record last verified: 2022-05