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NCT Number: NCT06023888

Waveform Periodicity Analysis in Patients With Persistent Atrial Fibrillation

STUDY DESIGN A prospective study.

OBJECTIVE A single center clinical trial on the analysis of intracardiac atrial electrogram waveform periodicity for catheter ablation of persistent atrial fibrillation with OCTARAY™ Mapping Catheter, as prospective randomized controlled study.

HYPOTHESIS:

The critical atrial substrates in maintaining persistent atrial fibrillation could be identified by non-linear electrogram morphology analysis in a point-by-point electroanatomic mapping. Based on the previous study, atrial substrate with high-similarity electrogram regions correlated with procedural AF termination and better long-term AF-free (1). Therefore, we proposed that the degree of waveform similarity plus the beat-to-beat sequential morphology (2) (duration of how many similar waveforms can maintain in sequence) would be even better to characterize the atrial substrate and could be potentially critical atrial substrate in prediction of sources of AF. As additional substrate mapping provided benefits compared to PVI alone in patients with persistent AF, we hypothesize that waveform periodicity adjuvant to electrogram similarity and phase mapping could be used to guide radiofrequency ablation in real time. The used of the OCTARAY™ Mapping Catheter could collected more AF electrogram and facilitate the mapping resolution and driver identification.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • persistent atrial fibrillation
  • refractory or intolerant to medication

Exclusion criteria

  • Previous AF ablation
  • LA thrombus
  • Previous MAZE procedure
  • Poor renal function
  • Can't follow-up for one year

Treatment and study plan

Mapping strategy

Other

The ablation strategy was based on the mapping results of periodicity.

Primary outcomes

  1. Recurrence of atrial arrhythmia

    Time frame: up to 6 month

    atrial arrhythmia in 24-hour monitoring

  2. Recurrence of atrial arrhythmia

    Time frame: up to 1 year

    atrial arrhythmia in 7-day ECG monitoring(RootiRx®)

    The RootiRx® multi-sensor patch-type system is a water-resistant compact ECG patch of 62 × 22 × 9mm size and 14g of weight. It is applied on the patient left chest similar to lead II location and it is fixed on a disposable self-adhesive patch then connected to the skin with two electrodes. RootiRx Syste can make continuous ECG monitoring up to seven days at a sampling frequency of 250Hz with 24-bit high resolution. Proprietary algorithms are used to analyze recorded data.

Study contacts

Contact information is provided by the study sponsor or research team.

CHIN-YU LIN, DR

CONTACT

[email protected]

+886983215656

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

A Prospective Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms With OctaRay in Patients With Persistent Atrial Fibrillation

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 5, 2023
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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