Evaluation of Optimal Ablation Index for Pulmonary Vein Isolation in Patients With AF Prospective Registry

NCT03389074 | Unknown DMC

• 1 other identifier: OPTIMUM
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators identify the optimal AI value for achieving good acute outcomes in PVI. Through the Phase 1 study, the investigators will prospectively analyze data including ablation parameters, AI and acute outcomes of 20 patients performed PVI with conventional ablation strategy (AI-blinded). After Phase 1 study results, optimal target AI value for each predefined PV segment will be determined. Then, by applying optimal AI values derived from the Phase 1 study, the investigators will evaluate the feasibility of the AI-guided procedure and verify the optimal AI value for acute PVI outcomes in the prospectively enrolled patients (n = 30) in the Phase 2 study.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• recurrence of a-fib

  Early recurrence and late recurrence(after 1-year)

  1 year

Interventions

Radiofrequency catheter ablation PROCEDURE

minimally-invasive procedure used to remove or terminate a faulty electrical pathway from sections of the hearts of those who are prone to developing cardiac arrhythmias.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Korean

You may qualify if:

• to 80 years old
• Patients with symptomatic paroxysmal or persistent AF who had failed with anti-arrhythmic agents

You may not qualify if:

• Patients who had previous ablation for AF
• Patients with left atrial (LA) diameter more than 50mm
• Inability or unwillingness to receive oral anticoagulation with a Vitamin K antagonist (VKA)or non-VKA (NOAC) agent
• Known severe left ventricular systolic function (ejection fraction\<35%)
• Pregnancy

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National university Hostpital

Seoul, 03080, South Korea

Location

Related Publications (1)

• Lee SR, Choi EK, Lee EJ, Choe WS, Cha MJ, Oh S. Efficacy of the optimal ablation index-targeted strategy for pulmonary vein isolation in patients with atrial fibrillation: the OPTIMUM study results. J Interv Card Electrophysiol. 2019 Aug;55(2):171-181. doi: 10.1007/s10840-019-00565-4. Epub 2019 May 17.

  PMID: 31102113 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Euekeun Choi, M.D. Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: January 3, 2018
• Study Start: January 23, 2017
• Primary Completion: September 9, 2019
• Study Completion: December 31, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)