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High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients (HPvSP-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250181
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Maciej Wójcik, MD, PhD, Medical University of Lublin

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

Condition or disease Intervention/treatment
Atrial Fibrillation Other: RF ablation of atrial fibrillation

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official 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
Actual Study Start Date : November 15, 2019
Actual Primary Completion Date : January 20, 2020
Actual Study Completion Date : February 8, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Standard RF
ablation with RF power of 30 Watts (30W) and with 25 Watts (25W) on posterior wall
Other: RF ablation of atrial fibrillation
Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation

High RF 40W (40 Watts)
ablation with RF power of 40 watts (40W)
Other: RF ablation of atrial fibrillation
Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation

High RF 50W (50 Watts)
ablation with RF power of 50 watts (50W)
Other: RF ablation of atrial fibrillation
Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation




Primary Outcome Measures :
  1. Procedure time: [ Time Frame: procedure ]
    Total procedure time (needle to needle time).


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with atrial fibrillation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250181


Locations
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Poland
Medical University of Lublin
Lublin, Poland, 20-091
Sponsors and Collaborators
Medical University of Lublin
Investigators
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Principal Investigator: MACIEJ MACIEJ, MD MEDICAL UNIVERSITY OF LUBLIN, POLAND
Publications of Results:
Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1.

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Responsible Party: Maciej Wójcik, MD, PhD, Clinical Professor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT04250181    
Other Study ID Numbers: HPvSP-AF ablation
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maciej Wójcik, MD, PhD, Medical University of Lublin:
atrial fibrillation ablation
high power radiofrequency ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes