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ECGI in Patients With Persistent Atrial Fibrillation

Identification of AF Triggers, Initiators and Perpetuators by Electro Cardio-Graphic Imaging (ECGI) in Patients With Persistent Atrial Fibrillation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03836092
Enrollment
50
Registered
2019-02-11
Start date
2018-02-23
Completion date
2022-04-01
Last updated
2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with persistent atrial fibrillation.

Detailed description

The patient population will include symptomatic persistent AF patients (N=50). The total of fifty patients will be studied to determine: * The values and limitations of ECGI in identifying atrial fibrillation (AF) triggers, AF initiators and AF perpetuators as targets sites for catheter ablations in patients with persistent AF. * The mechanisms of residual atrial tachycardia/flutter (Res-AT/AFl) after AF substrate ablations by targeting complex fractionated atrial electrograms (CFAE). * If there is a relationship between primary CFAE sites and driver sites or other distinct patterns from the ECGI mapping system. * The rate of AF termination to sinus rhythm after ablation at target sites identified by ECGI

Interventions

PROCEDURERadiofrequency ablation

RF applications were delivered with a maximal temperature of 43°C at the catheter tip (SmartTouch Navistar Thermocool catheter) and at the power between 25-50 watts. The primary end points during RF ablation were either complete elimination of areas with CFAE or conversion of AF to normal sinus rhythm (SR). When areas with CFAE were completely eliminated but the atrial arrhythmias persisted (organized atrial flutter or atrial tachycardia), they were subsequently mapped and ablated (occasionally in conjunction with ibutilide, 1 - 2 mgs intravenously over 10 minutes).

Sponsors

Pacific Rim Electrophysiology Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients are diagnosed as persistent AF. Persistent AF was defined as continuous AF from 7 days to 12 months and long- lasting AF beyond twelve months. * Patients who are symptomatic * Patients who are willing to sign consent and be followed post procedure in an out- patient arrhythmia clinic

Exclusion criteria

* Patients under 18 years or over 85 years of age. * Patients with chronic alcoholism. * Recent myocardial infarction within one month of the study. * Significant debilitating diseases or a terminal disease. * Patients with documented left atrial thrombus. * Medical or mental conditions precluding a long-term follow-up.

Design outcomes

Primary

MeasureTime frameDescription
Freedom from Atrial Fibrillation1 yeartermination via ablation from atrial fibrillation during follow up period

Secondary

MeasureTime frameDescription
termination via ablation from atrial fibrillation during procedureover 6 monthsTermination of AF to NSR during procedure

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026