Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation

NCT06647251 | Recruiting

• 1 other identifier: RYTHMO-03-2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary vein isolation is the main treatment of paroxysmal and persistent atrial fibrillation. The aim of our study is to prospectively compare the efficacy and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Incidence of primary adverse events related to the ablation procedure

  Incidence of primary adverse events within 7 days after ablation in the 3 arms

  7 days after ablation

• Acute procedural success

  Acute procedural success is defined as electrical isolation of all pulmonary veins

  At the end of the ablation procedure

Secondary Outcomes (18)

• Incidence of serious adverse event

  within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure

• Rate of additional lesions

  At the end of the ablation procedure

• Location of additional lesions

  At the end of the ablation procedure

• Use of another catheter

  At the end of the ablation procedure

• Time spent in operating room

  At the end of the ablation procedure

Study Arms (3)

Q-MODE

ACTIVE COMPARATOR

Radiofrequency ablation with High Power - Short Duration (HPSD) up to 50W.

Procedure: Q-MODE : radiofrequency ablation up to 50W

Q-MODE+

ACTIVE COMPARATOR

Radiofrequency ablation with High Power - Short Duration (HPSD) up to 90W.

Procedure: Q-MODE+ : radiofrequency up to 90W

Hybride Q-MODE/Q-MODE+

ACTIVE COMPARATOR

A combination of the two ablation methods.

Procedure: Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part

Interventions

Q-MODE : radiofrequency ablation up to 50W PROCEDURE

The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care. For patient randomized in this arm, the device is set to Q-MODE option: the intensity of radiofrequency to isolate the pulmonary vein is limited to 50W.

Q-MODE

Q-MODE+ : radiofrequency up to 90W PROCEDURE

The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care. For patient randomized in this arm, the device is set to Q-MODE+ option: the intensity of radiofrequency to isolate the pulmonary vein is limited to 90W.

Q-MODE+

Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part PROCEDURE

The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care. For patient randomized in this arm, the device is set to "Q-MODE/Q-MODE+" option: the intensity of radiofrequency delivered to isolate the pulmonary vein is limited to 50W in the anterior part and to 90W in the posterior part.

Hybride Q-MODE/Q-MODE+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 or over
• First atrial fibrillation ablation
• Paroxysmal atrial fibillation defined as atrial fibrillation lasting less than 48 hours
• Early atrial fibrillation defined as atrial fibrillation lastiing between 7 days and 3 months
• At least one episode of atrial fibrillation in the year preceding study entry
• Patient affiliated to a health insurance

You may not qualify if:

• History of atrial fibrillation ablation (surgery or catheter)
• Documented left atrial thrombus
• Left atrial (LA) diameter \> 60mm / LA area \> 35cm2 / Left atrial volulme index (LAVI) \> 45ml/m2
• N/STEMI replacement or angioplasty or valve within 3 months prior to registration
• Any contraindication mentioned in the instructions for use of the QDOT MICRO™ bidirectional navigation catheter
• Patient unable to understand study information
• Patient deprived of liberty by judicial or administrative decision

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead

Study Sites (1)

Institut Mutualiste Montsouris

Paris, Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frédéric SEBAG

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naly ANDRIAMBAO

CONTACT

+33156616439; naly.andriambao@imm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to one of the following arms: Q-MODE, Q-MODE+, hybride Q-MODE/Q-MODE+. The number of patients in each arm is the same.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: October 17, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

FR (1)