Atrial FibrillationQDOTNCT06647251
Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation
A study testing Q-MODE : radiofrequency ablation up to 50W, Q-MODE+ : radiofrequency up to 90W and Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part in people with Atrial Fibrillation, run by Institut Mutualiste Montsouris at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Q-MODE : radiofrequency ablation up to 50W, Q-MODE+ : radiofrequency up to 90W and Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2024to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Mutualiste Montsouris
Paris, Paris, 75014
Frederic SEBAG, +33156616263, frederic.sebag@imm.fr
About this study
Official title: Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal AF Ablation: a Prospective Study
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
Read the detailed description
Pulmonary vein isolation (PVI) is the main treatment of paroxysmal and persistant atrial fibrillation.
PVI is achieved by point-by-point radiofrequency ablation that creates flexible lesion set within targeted area.
PVI using standard ablation catheter with limited power (50W) have been described in case series with favorable efficacy and safety.
QDOTMicro™ is a radiofrequency ablation catheter that incorporates advanced, high-energy ablation, improved temperature monitoring, optimized irrigation, and higher signal resolution.
QDOT Micro™ provides several options regarding radiofrequency administration :
- Q-MODE : provides high power short duration (HPSD) unitl 50W radiofrequency,
- Q-MODE+ : provides very high power very short duration (vHSPD) until 90W radiofrequency,
- Hybrid Q-MODE/Q-MODE+ : is a combination of two methods. In our experience, stability is a prerequisite for PVI with QDOT Micro™.
Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).
Recently, preliminary animal data argue in favor or reducing the interpoint distance with QDOT™.
To date, there is no study comparing the 3 options of radiofrequency delivery. The aim of our study is to prospectively compare the efficacity and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions.
The same device is used in all three randomisation groups. The difference between the intervention is the intensity of the radiofrequency applied.
- Conditions
- Atrial Fibrillation
- Being tested
- Q-MODE : radiofrequency ablation up to 50W, Q-MODE+ : radiofrequency up to 90W, Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-MODE : radiofrequency ablation up to 50WProcedure or surgery
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+ : radiofrequency up to 90WProcedure or surgery
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.
Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior partProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Q-MODE | Active comparator | Radiofrequency ablation with High Power - Short Duration (HPSD) up to 50W. Receives: Procedure: Q-MODE : radiofrequency ablation up to 50W |
| Q-MODE+ | Active comparator | Radiofrequency ablation with High Power - Short Duration (HPSD) up to 90W. Receives: Procedure: Q-MODE+ : radiofrequency up to 90W |
| Hybride Q-MODE/Q-MODE+ | Active comparator | A combination of the two ablation methods. Receives: Procedure: Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of primary adverse events related to the ablation procedure
Incidence of primary adverse events within 7 days after ablation in the 3 arms
Measured: 7 days after ablation
Acute procedural success
Acute procedural success is defined as electrical isolation of all pulmonary veins
Measured: At the end of the ablation procedure
Secondary outcomes (18)
Incidence of serious adverse event
Incidence of serious adverse events
Measured: within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure
Rate of additional lesions
Rate of additional lesions between all targeted veins and per subject
Measured: At the end of the ablation procedure
Location of additional lesions
Anatomical location of additional lesions
Measured: At the end of the ablation procedure
Use of another catheter
Use of another catheter than QDOT in all targeted veins
Measured: At the end of the ablation procedure
Time spent in operating room
Time spent in operating room
Measured: At the end of the ablation procedure
Skin-to-skin time
Skin-to-skin time
Measured: At the end of the ablation procedure
Glove-to-glove time
Glove-to-glove time = total procedure time
Measured: At the end of the ablation procedure
Mapping time
Mapping time
Measured: At the end of the ablation procedure
Total ablation time
Total ablation time
Measured: At the end of the ablation procedure
Left vein ablation time
Left vein ablation time
Measured: At the end of the ablation procedure
Right vein ablation time
Right vein ablation time
Measured: At the end of the ablation procedure
Number of radiofrequency applications
Number of radiofrequency applications
Measured: At the end of the ablation procedure
Number of vHPSD radiofrequency applications
Number of vHPSD (very High Power Short Duration) radiofrequency applications
Measured: At the end of the ablation procedure
Number of HPSD radiofrequency applications
Number of HPSD (High Power Short Duration) radiofrequency applications
Measured: At the end of the ablation procedure
Temperature
Temperature
Measured: At the end of the ablation procedure
Power
Power
Measured: At the end of the ablation procedure
Contact force
Contact force
Measured: At the end of the ablation procedure
Impedance
Impedance
Measured: At the end of the ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric SEBAG, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647251
- Sponsor's protocol ID
- RYTHMO-03-2024
- Acronym
- QDOT
- Status last verified
- Oct 2024
- First submitted
- 27 Aug 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal AF Ablation: a Prospective Study
- ClinicalTrials.gov ID
- NCT06647251
- Acronym / sponsor ID
- QDOT / RYTHMO-03-2024
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Pulmonary vein isolation (PVI) is the main treatment of paroxysmal and persistant atrial fibrillation.
PVI is achieved by point-by-point radiofrequency ablation that creates flexible lesion set within targeted area.
PVI using standard ablation catheter with limited power (50W) have been described in case series with favorable efficacy and safety.
QDOTMicro™ is a radiofrequency ablation catheter that incorporates advanced, high-energy ablation, improved temperature monitoring, optimized irrigation, and higher signal resolution.
QDOT Micro™ provides several options regarding radiofrequency administration :
- Q-MODE : provides high power short duration (HPSD) unitl 50W radiofrequency,
- Q-MODE+ : provides very high power very short duration (vHSPD) until 90W radiofrequency,
- Hybrid Q-MODE/Q-MODE+ : is a combination of two methods. In our experience, stability is a prerequisite for PVI with QDOT Micro™.
Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).
Recently, preliminary animal data argue in favor or reducing the interpoint distance with QDOT™.
To date, there is no study comparing the 3 options of radiofrequency delivery. The aim of our study is to prospectively compare the efficacity and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions.
The same device is used in all three randomisation groups. The difference between the intervention is the intensity of the radiofrequency applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Q-MODE | Active comparator | Procedure: Q-MODE : radiofrequency ablation up to 50WRadiofrequency ablation with High Power - Short Duration (HPSD) up to 50W. |
| Q-MODE+ | Active comparator | Procedure: Q-MODE+ : radiofrequency up to 90WRadiofrequency ablation with High Power - Short Duration (HPSD) up to 90W. |
| Hybride Q-MODE/Q-MODE+ | Active comparator | Procedure: Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior partA combination of the two ablation methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-MODE : radiofrequency ablation up to 50WThe 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. | Procedure or surgery | Q-MODE |
| Q-MODE+ : radiofrequency up to 90WThe 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. | Procedure or surgery | Q-MODE+ |
| Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior partThe 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. | Procedure or surgery | Hybride Q-MODE/Q-MODE+ |
Primary outcome
Incidence of primary adverse events related to the ablation procedure
Time frame: 7 days after ablation
Incidence of primary adverse events within 7 days after ablation in the 3 arms
Acute procedural success
Time frame: At the end of the ablation procedure
Acute procedural success is defined as electrical isolation of all pulmonary veins
18 secondary outcomes
Incidence of serious adverse event
Time frame: within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure
Rate of additional lesions
Time frame: At the end of the ablation procedure
Location of additional lesions
Time frame: At the end of the ablation procedure
Use of another catheter
Time frame: At the end of the ablation procedure
Time spent in operating room
Time frame: At the end of the ablation procedure
Skin-to-skin time
Time frame: At the end of the ablation procedure
Glove-to-glove time
Time frame: At the end of the ablation procedure
Mapping time
Time frame: At the end of the ablation procedure
Total ablation time
Time frame: At the end of the ablation procedure
Left vein ablation time
Time frame: At the end of the ablation procedure
Right vein ablation time
Time frame: At the end of the ablation procedure
Number of radiofrequency applications
Time frame: At the end of the ablation procedure
Number of vHPSD radiofrequency applications
Time frame: At the end of the ablation procedure
Number of HPSD radiofrequency applications
Time frame: At the end of the ablation procedure
Temperature
Time frame: At the end of the ablation procedure
Power
Time frame: At the end of the ablation procedure
Contact force
Time frame: At the end of the ablation procedure
Impedance
Time frame: At the end of the ablation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric SEBAG principal investigator
Institut Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q-MODE : radiofrequency ablation up to 50W, Q-MODE+ : radiofrequency up to 90W and Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part in people with Atrial Fibrillation, run by Institut Mutualiste Montsouris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naly ANDRIAMBAO (+33156616439, naly.andriambao@imm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of primary adverse events related to the ablation procedure (time frame: 7 days after ablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.