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Completed

NCT Number: NCT04250181

High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients

High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective procedure.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Lublin

Lublin, 20-091, Poland

About this study

Atrial fibrillation (AF) ablation is the most commonly performed radiofrequency (RF) ablation and is usually associated with a long procedural time and sensation of pain in conscious patients. Prolonged radiation exposure during the procedure puts the patient and the operator at risk of malignancy and genetic abnormalities. Complications such as asymptomatic cerebral lesions, tamponade, perforation, and also arrhythmia recurrence were associated with longer ablation time.

High-power, shorter-duration radiofrequency ablation (HPSDRFA) appears to be a novel concept for atrial fibrillation (AF) but there are scarce data in conscious patients. The lesion side index (LSI) value has been associated with durability of pulmonary vein isolation (PVI) lesions.

We hypothesised that HPSDRFA applications based on the lesion side index (LSI; its has been associated with durability of pulmonary vein isolation (PVI) lesions) which were not inferior to standard approach regarding safety and effectiveness with shorten procedure time and being less painful for a patient.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • symptomatic patients with non-valvular AF,
  • aged:18-85, first procedure in left atrium,
  • exclusion of thrombus in left atrium and left atrium appendage,
  • left ventricle ejection fraction >55%

Exclusion criteria

  • age below 18 or above 85 years,
  • left ventricle ejection fraction<55%,
  • previous procedure in left atrium,
  • valvular AF

Treatment and study plan

RF ablation of atrial fibrillation

Other

Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation

Primary outcomes

  1. Procedure time:

    Time frame: procedure

    Total procedure time (needle to needle time).

Secondary outcomes

  1. Left atrial dwelling time

    Time frame: transeptal access to removal of a catheter and a sheath

    time of left atrium instrumentation

  2. Voltage mapping time

    Time frame: procedure

    time needed to perform 3D electroanatomical map and high density voltage mapping of left atrium.

  3. Total RF time

    Time frame: procedure

    time of all performed radiofrequency (RF) applications

  4. Total number of RF applications

    Time frame: procedure

    number of all RF applications performed during a procedure

  5. X-Ray time

    Time frame: procedure

    the total time of fluoroscopy

  6. Complications

    Time frame: 12 months

    both procedure-related complications and all complications in 12 moths follow-up as follows: Cardiac tamponade/perforation [yes/no], Stroke/TIA (Transient ischemic attack) [yes/no], Oesophageal injury (perforation/fistula) [yes/no], Death (procedural related, one year follow up) [yes/no], Stem pops [yes/no], Catheter char [yes/no], Phrenic nerve paralysis [yes/no], PV stenosis requiring intervention [yes/no], Gastrointestinal bleeding or gastrointestinal complaints [yes/no], Need for periprocedural pacemaker implantation [yes/no], Vascular access complication which required intervention [yes/no], Vascular access complication which not required intervention [yes/no],

  7. Number of stopped RF applications as a result of pain complained by a patient

    Time frame: procedure

    the surrogate for assessment of the painfulness of the procedure

  8. Follow-up-30s

    Time frame: procedure

    absence any arrhythmia recurrence (AR) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL) lasting longer than 30 second

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

HPvSP-AF Trail: Is High RF Energy Ablation of Atrial Fibrillation Fast, Safe, Less Painful and Effective - a Propensity Score Matched Analysis of 30/25W, 40W and 50W RF Energy Settings

Acronym: HPvSP-AF

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2020
Registry last updated
Feb 18, 2020

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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