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

Sponsor

Medical University of Warsaw (Other)

Overall Status

Recruiting

CT.gov ID

NCT05780996

Collaborator

(none)

Enrollment

Locations

Arms

10.9

Anticipated Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: QMODE + Device: QMODE	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Very high-power short-duration 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.	Device: QMODE + Atrial fibrillation radiofrequency ablation of the anterior and posterior wall with 90W (vHPSD)
Active Comparator: High-power short-duration 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).	Device: QMODE Atrial fibrillation radiofrequency ablation of the anterior wall with 50W (HPSD). Ablation of the posterior wall with 90 W (vHPSD)

Arm

Intervention/Treatment

Active Comparator: Very high-power short-duration

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.

Device: QMODE +

Atrial fibrillation radiofrequency ablation of the anterior and posterior wall with 90W (vHPSD)

Active Comparator: High-power short-duration

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).

Device: QMODE

Atrial fibrillation radiofrequency ablation of the anterior wall with 50W (HPSD). Ablation of the posterior wall with 90 W (vHPSD)

Outcome Measures

Primary Outcome Measures

Acute procedural success [During ablation.]
First pass isolation of anterior wall of pulmonary veins.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre of Postgraduate Medical Education, Department of Cardiology, Grochowski Hospital, Warsaw, Poland.	Warsaw		Poland
2	Department of Internal Medicine and Cardiology with the Center for Diagnosis and Treatment of Venous Thromboembolism, Medical University of Warsaw, Warszawa, Poland	Warsaw		Poland