Personalized Atrial Fibrillation Ablation With QDOT

Sponsor

Antonio Berruezo, MD, PhD (Other)

Overall Status

Recruiting

CT.gov ID

NCT04298177

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Circumferential pulmonary vein isolation (PVI) has become a mainstay in the treatment of atrial fibrillation (AF), particularly in symptomatic patients with paroxysmal AF (PAF) intolerant or refractory to medical treatment. The safety and short-term performance of the novel QDOT® catheter (Biosense Webster, Irvine, CA, USA), that allows for a high-power short-duration (HPSD) ablation, has already been evaluated in the QDOT-FAST clinical study, with favorable data on feasibility and safety, and lowered fluoroscopy and procedure times needed to achieve complete PVI. HPSD ablation was based on immediate heat formation during the resistive phase, affecting a small tissue depth at 90 W/4 s (irrigation at 8 ml/min) with a temperature limit of 65ºC.

However, up to date there are no randomized studies evaluating the real usefulness of the QDOT® catheter. Longer-term follow-up is still required to verify the long-term effectiveness and correlations between short-term follow-up and arrhythmia recurrence when using this catheter. The impact of this novel catheter, when used in conjunction with a personalized ablation protocol that uses the information of left atrial wall thickness (LAWT) to modulate the AI target at each ablation point, compared with a standard ablation protocol following the published CLOSE study criteria is already unknown.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Atrial fibrillation ablation using the QDOT® catheter Procedure: Standard atrial fibrillation ablation	Phase 4

Detailed Description

Circumferential pulmonary vein isolation (PVI) has become a mainstay in the treatment of atrial fibrillation (AF), particularly in symptomatic patients with paroxysmal AF (PAF) intolerant or refractory to medical treatment. Dormant conduction and pulmonary vein reconnections are responsible for AF/atrial tachycardia (AT) recurrences owing to incomplete non-transmural ablation lesions that generate gaps on ablation lines.

The advent of contact force (CF) catheters has represented a significant milestone when reaching better efficiency in RF delivery, helping to achieve better PVI rates after AF ablation. The benefits of CF sensing have been already demonstrated in both the SMART AF (THERMOCOOL® SMARTTOUCH® Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation) and the TOCCASTAR (TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation) studies. Moreover, CF stability is also an important predictor of reduced arrhythmia recurrence.

Recently, ablation index (AI) (CARTO3® V4; Biosense Webster, Inc, Diamond Bar, CA, USA) was developed as a novel marker of lesion quality that, for the first time, incorporates CF as well as duration, and power delivery. The recent CLOSE clinical study analyzed the utility of ablation index (AI), a novel formula developed to assess real-time effect of RF delivery and improve the rates of permanent PVI, with 91.3% of the patients free from AF/AT/atrial flutter (AFL) at 12 months follow-up. The CLOSE protocol targeted an interlesion distance (ILD) of 6 mm and AI ≥ 400 at the posterior wall and ≥550 at the anterior wall.

However, another recent study revealed that AI, while being very reliable across a range of CF values, may be 'penalized' by small contact angles and high-power RF applications, which could decrease the lesion size at the same AI. The small lesion size at narrow contact angle may be explained by tip temperature drop due to saline flow from irrigation holes located at the side of the catheter tip during RF application. Bourier et al. reported that extremely high-power RF applications (> 50 W) resulted in significantly smaller lesion depth for short-duration applications (n = 120).

In a swine model, high-power short-duration (HPSD) ablation resulted in 100% contiguous lines with all transmural lesions, whereas standard ablation (25 W for 20 s) had linear gaps in 25% and partial thickness lesions in 29%. The authors of this experimental study used a novel ablation catheter that incorporates 6 thermocouples symmetrically embedded in the circumference of the tip electrode, named QDOT® catheter (Biosense Webster, Irvine, CA, USA). This catheter permits to control the confounding effect of the cold irrigation fluid during ablation, while having an improved irrigation system. In the same study, ablation with HPSD produced wider lesions at similar depth, and improved lesion-to-lesion uniformity with comparable safety endpoints. Given the aforesaid, it can be hypothesized that larger diameter of HPSD lesions might contribute to a complete encirclement of PV, by ensuring better contiguity between adjacent lesions, while the reduced lesion depth may still achieve lesion transmurality in atrial tissue, diminishing the risk of collateral tissue damage.

The safety and short-term performance of the QDOT® catheter (Biosense Webster, Irvine, CA, USA) has already been evaluated in the QDOT-FAST clinical study (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation), with favorable data on feasibility and safety, and lowered fluoroscopy and procedure times needed to achieve complete PVI. HPSD ablation was based on immediate heat formation during the resistive phase, affecting a small tissue depth at 90 W/4 s (irrigation at 8 ml/min) with a temperature limit of 65ºC.

Up to date, there are no randomized studies evaluating the real usefulness of the QDOT® catheter. Moreover, longer-term follow-up is required to verify the long-term effectiveness and correlations between short-term follow-up and arrhythmia recurrence when using this catheter. The impact of the QDOT® catheter, when used in conjunction with a personalized ablation protocol that uses the information of left atrial wall thickness (LAWT) to modulate the AI target at each ablation point, compared with a standard ablation protocol (CLOSE study criteria) is already unknown.

Our research hypothesis is that QDOT-by-LAW, a personalized protocol that uses a dedicated vHPSD catheter, a multichannel radiofrequency (RF) generator with a vHPSD ablation mode, and integrated LAWT information to adapt the ablation index (AI) target to the subjacent LAWT, is safe, while showing at least the same efficacy and better efficiency than the CLOSE protocol.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a two-arm, single-blind, single-center, randomized controlled trial.This is a two-arm, single-blind, single-center, randomized controlled trial.

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Personalized Atrial Fibrillation Ablation With the QDOT Catheter - The QDOT-by-LAW Trial

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QDOT-LAWT A QDOT® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Irvine, CA, USA) will be used. The primary ablation mode for PVI will depend on the calculated LAWT at each atrial point, as follows: < 3.5-mm LAWT (red, and yellow colors): vHPSD ablation will be performed. If <1-mm LAWT (red color): Power 90 W; the duration of RF applications will be reduced to 2 seconds. If 1-3.5 mm LAWT (yellow color): Power 90 W; the duration of RF applications will be 4 seconds, according to the QDOT-FAST protocol. > 3.5-mm LAWT (green color): QMODE ablation will be performed. 50 W with AI target = 500	Device: Atrial fibrillation ablation using the QDOT® catheter Atrial fibrillation ablation will be performed using the QDOT® catheter. The ablation mode will be selected according to the MDCT-derived LAWT information. Other Names: Pulmonary vein isolation
Active Comparator: CLOSE In the CLOSE arm, the use of MDCT-derived LAWT information will not be available for the operator. A ThermoCool® SmartTouch® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA) will be used. The ablation will be performed using a proprietary RF generator (SMARTABLATE®; Biosense Webster, Diamond Bar, CA, USA). Ablation will be performed according to the CLOSE study settings: Power-controlled mode (without ramping) with 25 to 35 W (irrigation flow 30 ml/min). RF will be delivered until an AI of ≥ 400 at the posterior wall/roof and ≥ 550 at the anterior wall are reached.	Procedure: Standard atrial fibrillation ablation Atrial fibrillation ablation will be performed using the SmartTouch® catheter. The ablation parameters will be adjusted according to the settings previously described in the CLOSE study. Other Names: Pulmonary vein isolation

Arm

Intervention/Treatment

Experimental: QDOT-LAWT

A QDOT® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Irvine, CA, USA) will be used. The primary ablation mode for PVI will depend on the calculated LAWT at each atrial point, as follows: **< 3.5-mm LAWT (red, and yellow colors): vHPSD ablation will be performed. If <1-mm LAWT (red color): Power 90 W; the duration of RF applications will be reduced to 2 seconds. If 1-3.5 mm LAWT (yellow color): Power 90 W; the duration of RF applications will be 4 seconds, according to the QDOT-FAST protocol. **> 3.5-mm LAWT (green color): QMODE ablation will be performed. 50 W with AI target = 500

Device: Atrial fibrillation ablation using the QDOT® catheter

Atrial fibrillation ablation will be performed using the QDOT® catheter. The ablation mode will be selected according to the MDCT-derived LAWT information.

Other Names:

Pulmonary vein isolation

Active Comparator: CLOSE

In the CLOSE arm, the use of MDCT-derived LAWT information will not be available for the operator. A ThermoCool® SmartTouch® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA) will be used. The ablation will be performed using a proprietary RF generator (SMARTABLATE®; Biosense Webster, Diamond Bar, CA, USA). Ablation will be performed according to the CLOSE study settings: Power-controlled mode (without ramping) with 25 to 35 W (irrigation flow 30 ml/min). RF will be delivered until an AI of ≥ 400 at the posterior wall/roof and ≥ 550 at the anterior wall are reached.

Procedure: Standard atrial fibrillation ablation

Atrial fibrillation ablation will be performed using the SmartTouch® catheter. The ablation parameters will be adjusted according to the settings previously described in the CLOSE study.

Other Names:

Pulmonary vein isolation

Outcome Measures

Primary Outcome Measures

Clinical efficacy [1 year]
Survival free of any atrial arrhythmia at the 3-month, 6-month, and 12-month follow-up.

Secondary Outcome Measures

Procedure time [1 month]
Procedure time (skin to skin)
Radiofrequency time [1 month]
Radiofrequency time
Number of radiofrequency applications [1 month]
Number of applications (total/per PVI RF line/per segment)
Fluoroscopy time [1 month]
Fluoroscopy time
First pass isolation rate [1 month]
First pass isolation rate
Early PV reconnection rate [1 month]
Early PV reconnection rate
Incidence of peri-procedural complications [1 month]
Incidence of peri-procedural complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18 years.
Indication for paroxysmal atrial fibrillation ablation.
Signed informed consent

Exclusion Criteria:

Age < 18 years.
Pregnancy.
Previous AF redo procedure.
Impossibility to perform a pre-procedural CT scan.
Concomitant investigation treatments.
Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.