NCT05381805Not yet recruiting
ISOLATION 2.0: a Multicenter Clinical Care and Research Platform
Intensive (Pre)Clinical Characterization of Patients undergOing Atrial fibrillATion ablatlON: a Multicenter Clinical Care and Research Platform
Source: ClinicalTrials.gov · Last updated 19 May 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 7 Apr 2022
- Start date
- 1 Aug 2022
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Atrial fibrillation
- NCT number
- NCT05381805
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 1 Aug 2022 to the primary completion date, 1 Aug 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Specific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical AF ablation):
Other illness
- Conditions preventing the patient from adhering from the study protocol;
- 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:
- 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.
Other
- 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:
Who the study is looking for
- 18 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.