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Radial Ablation for the Control of Persistent Atrial Fibrillation (ARTIST)

Primary Purpose

Persistent Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pulmonary vein electrical isolation
Radial ablation
Sponsored by
Fundacion para la Innovacion en Biomedicina (FIBMED)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Atrial fibrillation, Catheter ablation, Radial ablation, Rotors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years and ≤ 75 years.
  • Non-valvular symptomatic persistent atrial fibrillation.
  • Patient willingness to participate in the study providing signed written informed consent.
  • Failure or drug intolerance or refusal to continue with chronic antiarrhythmic treatment.
  • Left ventricular ejection fraction LVEF) ≥ 25 % in the last echocardiogram prior to enrollment.

Exclusion Criteria:

  • Left atrial diameter > 5.5 cm in the last echocardiogram.
  • Contraindication of chronic anticoagulation or heparin.
  • Previous atrial fibrillation ablation procedure.
  • Acute coronary syndrome, cardiac surgery or acute cerebrovascular accident in two months prior to enrollement.
  • Previous diagnosis for hyperthyroidism or hypothyroidism.
  • Mental or physical illness that disables the patient to participate in the study.
  • Scheduled cardiac percutaneous or surgical intervention.
  • Non-controlled hypertension > 160/100.
  • Terminal renal insufficiency or dialysis.
  • Functional class IV of the New York Heart Association (NYHA).
  • Moderate valvular disease or previous mitral prosthesis.
  • Previous hypertrophic heart disease.
  • Life expectancy less than 12 months.
  • Inclusion on the transplant list.
  • Participation in another study so as not to interfere with the results.
  • Previous atrioventricular block.
  • Pericardial effusion.
  • Pregnancy or childbearing age without contraceptive treatment.

Sites / Locations

  • Hospital Universitario Puerta de HierroRecruiting
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control arm. Pulmonary vein isolation

Treatment arm. Radial ablation

Arm Description

Pulmonary vein isolation with ablation.

Pulmonary vein isolation plus radial ablation of rotational activity sites.

Outcomes

Primary Outcome Measures

Atrial fibrillation burden (1 year)
Atrial fibrillation burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial fibrillation episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Atrial flutter burden (1 year)
Atrial flutter burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial flutter episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Atrial tachycardia burden (1 year)
Atrial tachycardia burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial tachycardia episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

Secondary Outcome Measures

Occurrence of severe complication of the ablation procedure
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports. One week post-procedural complications included. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Overall clinical procedure, radiofrequency and fluoroscopy durations
Total time registered during the clinical procedure. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Accute procedural success rate
Accute procedural success as the percentage of episodes that revert to sinus flutter or sinus rhythm during the ablation procedure. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Occurrence of hospitalization for cardiovascular cause
Unforeseen hospitalization for cardiovascular cause requiring overnight hospital stay during the 12 month follow-up. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Cerebrovascular accident unforeseen hospitalization
Unforeseen hospitalization due to cerebrovascular accident (CVA) requiring overnight hospital stay during the 12 month follow-up. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Heart failure unforeseen hospitalization
Unforeseen hospitalization due to new diagnosis for heart failure requiring overnight hospital stay during the 12 month follow-up. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Functional class worsening unforeseen hospitalization
Unforeseen hospitalization due to functional class worsening due to heart failure requiring overnight hospital stay during the 12 month follow-up. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Final functional class at the end of the study
Final functional class at the end of the study. New York Heart Association (NYHA) classification. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Total and cardiac mortality
Total and cardiac mortality Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Quality of life measured with the The Short Form (36) Health Survey
Quality of life is measured with the The Short Form (36) Health Survey at pre-specified study follow-up visits (4, 8, 12 months). The short-form (36) health survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.

Full Information

First Posted
November 24, 2020
Last Updated
December 26, 2022
Sponsor
Fundacion para la Innovacion en Biomedicina (FIBMED)
Collaborators
Hospital General Universitario Gregorio Marañon, Hospital Universitario 12 de Octubre, Puerta de Hierro University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04662489
Brief Title
Radial Ablation for the Control of Persistent Atrial Fibrillation
Acronym
ARTIST
Official Title
Radial Ablation for the Control of Persistent Atrial Fibrillation (Ablación Radial Para conTrol de la fibrilación Auricular persISTtente)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Innovacion en Biomedicina (FIBMED)
Collaborators
Hospital General Universitario Gregorio Marañon, Hospital Universitario 12 de Octubre, Puerta de Hierro University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The protocol aims to evaluate the efficacy of the radial ablation technique of the maintenance mechanisms in persistent atrial fibrillation compared to the isolation of the pulmonary veins evaluating the atrial fibrillation burden during one year follow-up.
Detailed Description
Atrial fibrillation is the most common arrhythmia in clinical practice, and its treatment still remains suboptimal. Electrical isolation of the pulmonary veins with radiofrequency ablation or cryoablation is the standard therapy when antiarrhythmic drugs or electrical cardioversion is not successful. However, recurrence after catheter ablation worsens in persistent and permanent atrial fibrillation patients. Recently, rotational activity electrogram patterns of self-sustained electrical activity found in the atria have been proposed as the responsible mechanism for the maintenance of atrial fibrillation. The investigators devised a controlled, multicentric, prospective, not blinded, and randomized clinical trial with the aim of comparing pulmonary vein catheter ablation versus radial ablation of sites exhibiting rotational activity in patients with persistent atrial fibrillation. Radial ablation consists of the ablation of the rotational activity sites and an additional ablation line connecting the rotation site with the circumferential ablation line of the pulmonary veins. Besides, subanalysis ARTIST-Gender and ARTIST-HF will be performed. ARTIST-Gender will compare the same outcomes and analysis of the patient cohort but according to the gender of the patient, and ARTIST-HF will sub-divide the analysis with respect to heart failure present in the enrolled patients' cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Atrial fibrillation, Catheter ablation, Radial ablation, Rotors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control and treatment arms. Control group refers to pulmonary vein isolation ablation. Treatment group refers to pulmonary vein isolation plus radial ablation of rotational activity sites.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm. Pulmonary vein isolation
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation with ablation.
Arm Title
Treatment arm. Radial ablation
Arm Type
Experimental
Arm Description
Pulmonary vein isolation plus radial ablation of rotational activity sites.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein electrical isolation
Other Intervention Name(s)
Pulmonary veins ablation
Intervention Description
Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy
Intervention Type
Procedure
Intervention Name(s)
Radial ablation
Intervention Description
Electrical isolation of the pulmonary veins from the left atrium plus radial ablation of rotational activity sites with radiofrequency ablation.
Primary Outcome Measure Information:
Title
Atrial fibrillation burden (1 year)
Description
Atrial fibrillation burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial fibrillation episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
Title
Atrial flutter burden (1 year)
Description
Atrial flutter burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial flutter episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
Title
Atrial tachycardia burden (1 year)
Description
Atrial tachycardia burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial tachycardia episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
Secondary Outcome Measure Information:
Title
Occurrence of severe complication of the ablation procedure
Description
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports. One week post-procedural complications included. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
2 years
Title
Overall clinical procedure, radiofrequency and fluoroscopy durations
Description
Total time registered during the clinical procedure. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
2 years
Title
Accute procedural success rate
Description
Accute procedural success as the percentage of episodes that revert to sinus flutter or sinus rhythm during the ablation procedure. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
2 years
Title
Occurrence of hospitalization for cardiovascular cause
Description
Unforeseen hospitalization for cardiovascular cause requiring overnight hospital stay during the 12 month follow-up. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
1 year
Title
Cerebrovascular accident unforeseen hospitalization
Description
Unforeseen hospitalization due to cerebrovascular accident (CVA) requiring overnight hospital stay during the 12 month follow-up. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
1 year
Title
Heart failure unforeseen hospitalization
Description
Unforeseen hospitalization due to new diagnosis for heart failure requiring overnight hospital stay during the 12 month follow-up. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
1 year
Title
Functional class worsening unforeseen hospitalization
Description
Unforeseen hospitalization due to functional class worsening due to heart failure requiring overnight hospital stay during the 12 month follow-up. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
1 year
Title
Final functional class at the end of the study
Description
Final functional class at the end of the study. New York Heart Association (NYHA) classification. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
2 years
Title
Total and cardiac mortality
Description
Total and cardiac mortality Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
2 years
Title
Quality of life measured with the The Short Form (36) Health Survey
Description
Quality of life is measured with the The Short Form (36) Health Survey at pre-specified study follow-up visits (4, 8, 12 months). The short-form (36) health survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years and ≤ 75 years. Non-valvular symptomatic persistent atrial fibrillation. Patient willingness to participate in the study providing signed written informed consent. Failure or drug intolerance or refusal to continue with chronic antiarrhythmic treatment. Left ventricular ejection fraction LVEF) ≥ 25 % in the last echocardiogram prior to enrollment. Exclusion Criteria: Left atrial diameter > 5.5 cm in the last echocardiogram. Contraindication of chronic anticoagulation or heparin. Previous atrial fibrillation ablation procedure. Acute coronary syndrome, cardiac surgery or acute cerebrovascular accident in two months prior to enrollement. Previous diagnosis for hyperthyroidism or hypothyroidism. Mental or physical illness that disables the patient to participate in the study. Scheduled cardiac percutaneous or surgical intervention. Non-controlled hypertension > 160/100. Terminal renal insufficiency or dialysis. Functional class IV of the New York Heart Association (NYHA). Moderate valvular disease or previous mitral prosthesis. Previous hypertrophic heart disease. Life expectancy less than 12 months. Inclusion on the transplant list. Participation in another study so as not to interfere with the results. Previous atrioventricular block. Pericardial effusion. Pregnancy or childbearing age without contraceptive treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angel Arenal, MD, PhD
Phone
0034915868290
Email
arenal@secardiologia.es
First Name & Middle Initial & Last Name or Official Title & Degree
Gonzalo R. Ríos-Muñoz, MSc, PhD
Phone
0034915868290
Email
gonzalo.rios.munoz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angel Arenal, MD, PhD
Organizational Affiliation
Hospital General Universitario Gregorio Marañón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Fernández Lozano, MD, PhD
Phone
0034911916000
Email
iflozano@secardiologia.es
First Name & Middle Initial & Last Name & Degree
Ignacio Fernández Lozano, MD, PhD
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Arenal, MD, PhD
Phone
0034915868290
First Name & Middle Initial & Last Name & Degree
Angel Arenal, MD, PhD
First Name & Middle Initial & Last Name & Degree
Gonzalo R. Ríos-Muñoz, MSc, PhD
First Name & Middle Initial & Last Name & Degree
Nina Soto, MD
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Arribas, MD, PhD
Phone
0034913908000
Email
farribas@secardiologia.es
First Name & Middle Initial & Last Name & Degree
Fernando Arribas, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radial Ablation for the Control of Persistent Atrial Fibrillation

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