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Completed

NCT Number: NCT03634592

AF Ablation With the Ablation Index

This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology.

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Key information

Conditions

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

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation

Saint Petersburg, 197341, Russia

About this study

This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology, which has been introduced as a tool predicting ablation lesion depth. The index incorporates the following characteristics of radiofrequency point-by-point ablation: radiofrequency energy power, contact force, duration of ablation. Since the ablation index is calculated for every individual operator depending on his(her) personal skills, there is no a strict indication on the safe and effective range of the index. This registry aims to evaluate ablation index values used in different centers by different operators. Prospective information on arrhythmia recurrence rate and type, characteristics of redo ablations, characteristics of reconduction ablated areas will be gathered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • indications for catheter ablation of atrial fibrillation;
  • signed informed consent

Exclusion criteria

  • Presence of contraindications to AF ablation

Treatment and study plan

Catheter ablation

Procedure

Radiofrequency catheter pulmonary vein isolation

Primary outcomes

  1. Freedom from atrial fibrillation

    Time frame: 1 year

    Number of participants with no evidence of atrial tachyarrhythmia longer than 30 s in duration at 12 months after ablation, as detected by regular ECG monitoring according to centres' established practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening). Data will be collected using a web-based system with electronic case report forms.

Secondary outcomes

  1. Acute complications

    Time frame: 30 days

    Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc) whithin 30 days after ablation. Data will be collected using a web-based system with electronic case report forms.

  2. Procedure time

    Time frame: 180 minutes

    Duration of the total ablation procedure and fluoroscopy needed to complete pulmonary vein isolation, expressed in minutes.

  3. Fluoroscopy time

    Time frame: 24 hours

    Fluoroscopy duration within the procedure

  4. Electrical reconduction

    Time frame: 2 years

    Number of participats with electrical reconduction into pulmonary veins as assessed during repeat procedures.

Sponsors and collaborators

Lead sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Other

Registry information

Official study title

A Prospective Registry of Atrial Fibrillation Ablation Using the Prediction of Lesion Depth Technology

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Aug 16, 2018
Registry last updated
Mar 5, 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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