search
Back to results

Efficacy of Anterior Wall PVI With QDOT Catheter - Intraprocedural Comparison Between vHPSD and HPSD Ablation. (A-Q-RATE-POWER)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
QMODE +
QMODE
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, QDOT, very high power short-duration, pulmonary vein isolation, left atrial wall thickness, catheter ablation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient scheduled for their first AF ablation procedure Written informed consent Paroxysmal or persistent AF Age > 18 Exclusion Criteria: previous ablation procedure with pulmonary vein isolation lack of written informed consent pregnancy

Sites / Locations

  • Centre of Postgraduate Medical Education, Department of Cardiology, Grochowski Hospital, Warsaw, Poland.Recruiting
  • Department of Internal Medicine and Cardiology with the Center for Diagnosis and Treatment of Venous Thromboembolism, Medical University of Warsaw, Warszawa, PolandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Very high-power short-duration

High-power short-duration

Arm Description

A QDOT® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Irvine, CA, USA) will be used. In this group vHPSD (90W) will be performed. This power settings will be used for all ablation points.

A QDOT® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Irvine, CA, USA) will be used. Ablation of the anterior aspect of the pulmonary veins will be performed with high-power short-duration (50 W) with target ablation index =550. Ablation of the posterior wall of the pulmonary veins will be performed with vHPSD (90W).

Outcomes

Primary Outcome Measures

Acute procedural success
First pass isolation of anterior wall of pulmonary veins.

Secondary Outcome Measures

Number of additional RF application needed to obtain pulmonary vein isolation
Number of additional RF application needed to obtain pulmonary vein isolation
percentage of pulmonary vein pairs isolated with first encirclement
percentage of pulmonary vein pairs isolated with first encirclement
Total procedure duration
skin to skin procedure duration
Incidence of peri-procedural complications
Incidence of peri-procedural complications such as cardiac tamponade, stroke, pericardial effusion > 1 cm, TIA, vascular complications.
Fluoroscopy time
fluoroscopy time
Change of heart rhythm after right pulmonary veins isolation
Change of heart rhythm after right pulmonary veins isolation

Full Information

First Posted
March 10, 2023
Last Updated
March 10, 2023
Sponsor
Medical University of Warsaw
search

1. Study Identification

Unique Protocol Identification Number
NCT05780996
Brief Title
Efficacy of Anterior Wall PVI With QDOT Catheter - Intraprocedural Comparison Between vHPSD and HPSD Ablation.
Acronym
A-Q-RATE-POWER
Official Title
Optimization of PVI Strategy Using QDOT Catheter. What is the Proper Energy Level for Anterior Wall of Pulmonary Veins- Intraprocedural Efficacy Comparison Between HSPD and vHPSD (The A-Q-RATE POWER Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

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

5. Study Description

Brief Summary
This study is a prospective, randomized controlled study to evaluate intraprocedural efficacy of anterior aspects of pulmonary veins insolation between very High Power Short Duration (vHPSD) and High Power Short Duration (HPSD) in patient with paroxysmal or persistent Atrial Fibrillation.
Detailed Description
This study is a dual-center, prospective, randomized controlled study to evaluate intraprocedural efficacy of anterior aspects of pulmonary veins isolation between very High Power Short Duration (vHPSD) and High Power Short Duration (HPSD) in patient with paroxysmal or persistent atrial fibrillation (AF). Catheter ablation of atrial fibrillation with circumferential pulmonary vein isolation is an well-established method of treatment, particularly in symptomatic patients with atrial fibrillation (AF) who are ineffective or refractory to pharmacological treatment. Recurrence of pulmonary veins conduction is considered as a risk factor for future recurrence of AF. This may be partly related to the incomplete scar formation during the index ablation procedure. Constant technological progress (i.e. ablation catheters with contact force) has led to greater efficiency in obtaining complete isolation of pulmonary veins, achieving nearly 90% success rate in 12-month follow-up paroxysmal AF (CLOSE protocol). The duration of the RF application depends on the ablation index (AI), which proves that the energy has been effectively delivered to the myocardium. Currently, AI values are considered representative of RF power up to 50W. When energy above 50 W was used, the scar size was shown to be smaller than when the same AI value was used but with higher power. The safety and efficacy of novel ablation catheter QDOT (Biosense Webster, Irvine, CA, USA), that allows to deliver very high and high-power short-duration ablation, was already proven in clinical trials (QDOT FAST, Q-FFICIENCY). The benefits from using very high power short-duration ablation include: 1) shortening the duration of the procedure, 2) reducing the volume of fluids administered through the ablation electrode during RF application, which may be important in patients with heart and kidney failure, 3) reducing the frequency of collateral damages to surrounding structures of the heart (e.g. oesophagus). One of the differences related to the biophysics of RF applications between high and low energy is the range of penetration into the muscle tissue, which could impact on effectiveness of ablation. It was shown that lesions performed with vHPSD were smaller (up to 2,9 mm deep) compared to HPSD or conventional power with target AI. It is attractive for posterior wall of left atrium and can reduce peri-procedural complications. However vHPSD could be insufficient in some regions of anterior wall of the left atrium, which thickness may vary from 1 to 4 mm. Our research hypothesis is that integrated approach with different energies depending on the left atrium location is safe and lead to better efficacy than use of only vHPSD ablation in terms of first pass isolation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, QDOT, very high power short-duration, pulmonary vein isolation, left atrial wall thickness, catheter ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Very high-power short-duration
Arm Type
Active Comparator
Arm Description
A QDOT® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Irvine, CA, USA) will be used. In this group vHPSD (90W) will be performed. This power settings will be used for all ablation points.
Arm Title
High-power short-duration
Arm Type
Active Comparator
Arm Description
A QDOT® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Irvine, CA, USA) will be used. Ablation of the anterior aspect of the pulmonary veins will be performed with high-power short-duration (50 W) with target ablation index =550. Ablation of the posterior wall of the pulmonary veins will be performed with vHPSD (90W).
Intervention Type
Device
Intervention Name(s)
QMODE +
Intervention Description
Atrial fibrillation radiofrequency ablation of the anterior and posterior wall with 90W (vHPSD)
Intervention Type
Device
Intervention Name(s)
QMODE
Intervention Description
Atrial fibrillation radiofrequency ablation of the anterior wall with 50W (HPSD). Ablation of the posterior wall with 90 W (vHPSD)
Primary Outcome Measure Information:
Title
Acute procedural success
Description
First pass isolation of anterior wall of pulmonary veins.
Time Frame
During ablation.
Secondary Outcome Measure Information:
Title
Number of additional RF application needed to obtain pulmonary vein isolation
Description
Number of additional RF application needed to obtain pulmonary vein isolation
Time Frame
during ablation
Title
percentage of pulmonary vein pairs isolated with first encirclement
Description
percentage of pulmonary vein pairs isolated with first encirclement
Time Frame
during ablation
Title
Total procedure duration
Description
skin to skin procedure duration
Time Frame
during ablation
Title
Incidence of peri-procedural complications
Description
Incidence of peri-procedural complications such as cardiac tamponade, stroke, pericardial effusion > 1 cm, TIA, vascular complications.
Time Frame
during ablation
Title
Fluoroscopy time
Description
fluoroscopy time
Time Frame
during ablation
Title
Change of heart rhythm after right pulmonary veins isolation
Description
Change of heart rhythm after right pulmonary veins isolation
Time Frame
during ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient scheduled for their first AF ablation procedure Written informed consent Paroxysmal or persistent AF Age > 18 Exclusion Criteria: previous ablation procedure with pulmonary vein isolation lack of written informed consent pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Gardziejczyk, MD
Phone
225022091
Email
piotrgardziejczyk@uckwum.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Gardziejczyk, MD
Organizational Affiliation
Department of Internal Medicine and Cardiology, Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Postgraduate Medical Education, Department of Cardiology, Grochowski Hospital, Warsaw, Poland.
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakub Baran
Email
jakub.baran1111@gmail.com
Facility Name
Department of Internal Medicine and Cardiology with the Center for Diagnosis and Treatment of Venous Thromboembolism, Medical University of Warsaw, Warszawa, Poland
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Gardziejczyk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are open to collaboration but do not plan to give our data to others
Citations:
PubMed Identifier
29021841
Citation
Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary. J Arrhythm. 2017 Oct;33(5):369-409. doi: 10.1016/j.joa.2017.08.001. Epub 2017 Sep 15. No abstract available.
Results Reference
background
PubMed Identifier
29846987
Citation
Barkagan M, Contreras-Valdes FM, Leshem E, Buxton AE, Nakagawa H, Anter E. High-power and short-duration ablation for pulmonary vein isolation: Safety, efficacy, and long-term durability. J Cardiovasc Electrophysiol. 2018 Sep;29(9):1287-1296. doi: 10.1111/jce.13651. Epub 2018 Jun 20.
Results Reference
background
PubMed Identifier
31320006
Citation
Reddy VY, Grimaldi M, De Potter T, Vijgen JM, Bulava A, Duytschaever MF, Martinek M, Natale A, Knecht S, Neuzil P, Purerfellner H. Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial. JACC Clin Electrophysiol. 2019 Jul;5(7):778-786. doi: 10.1016/j.jacep.2019.04.009. Epub 2019 May 8.
Results Reference
background
PubMed Identifier
34381869
Citation
Richard Tilz R, Sano M, Vogler J, Fink T, Saraei R, Sciacca V, Kirstein B, Phan HL, Hatahet S, Delgado Lopez L, Traub A, Eitel C, Schluter M, Kuck KH, Heeger CH. Very high-power short-duration temperature-controlled ablation versus conventional power-controlled ablation for pulmonary vein isolation: The fast and furious - AF study. Int J Cardiol Heart Vasc. 2021 Jul 26;35:100847. doi: 10.1016/j.ijcha.2021.100847. eCollection 2021 Aug.
Results Reference
background
PubMed Identifier
36752484
Citation
Osorio J, Hussein AA, Delaughter MC, Monir G, Natale A, Dukkipati S, Oza S, Daoud E, Di Biase L, Mansour M, Fishel R, Valderrabano M, Ellenbogen K; Q-FFICIENCY Trial Investigators. Very High-Power Short-Duration, Temperature-Controlled Radiofrequency Ablation in Paroxysmal Atrial Fibrillation: The Prospective Multicenter Q-FFICIENCY Trial. JACC Clin Electrophysiol. 2023 Apr;9(4):468-480. doi: 10.1016/j.jacep.2022.10.019. Epub 2023 Jan 18.
Results Reference
background
PubMed Identifier
25125294
Citation
Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.
Results Reference
background
PubMed Identifier
32819533
Citation
Yavin HD, Leshem E, Shapira-Daniels A, Sroubek J, Barkagan M, Haffajee CI, Cooper JM, Anter E. Impact of High-Power Short-Duration Radiofrequency Ablation on Long-Term Lesion Durability for Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2020 Aug;6(8):973-985. doi: 10.1016/j.jacep.2020.04.023.
Results Reference
background
PubMed Identifier
30067486
Citation
Leshem E, Zilberman I, Tschabrunn CM, Barkagan M, Contreras-Valdes FM, Govari A, Anter E. High-Power and Short-Duration Ablation for Pulmonary Vein Isolation: Biophysical Characterization. JACC Clin Electrophysiol. 2018 Apr;4(4):467-479. doi: 10.1016/j.jacep.2017.11.018. Epub 2018 Feb 2.
Results Reference
background
PubMed Identifier
36116038
Citation
Lozano-Granero C, Franco E, Matia-Frances R, Hernandez-Madrid A, Sanchez-Perez I, Zamorano JL, Moreno J. Characterization of high-power and very-high-power short-duration radiofrequency lesions performed with a new-generation catheter and a temperature-control ablation mode. J Cardiovasc Electrophysiol. 2022 Dec;33(12):2528-2537. doi: 10.1111/jce.15676. Epub 2022 Sep 24.
Results Reference
background

Learn more about this trial

Efficacy of Anterior Wall PVI With QDOT Catheter - Intraprocedural Comparison Between vHPSD and HPSD Ablation.

We'll reach out to this number within 24 hrs