Atrial FibrillationNCT05368610
Lesion Contiguity in Very High Power-short Duration Ablation
An observational study of Atrial Fibrillation, run by University of Barcelona at 1 site in Spain.
Trial summary
This observational trial investigates the effect of very high power-short duration radiofrequency ablation on lesion contiguity as assessed by late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2022to Jun 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: All patients scheduled for PVI-only catheter ablation at Hospital Clinic, University of Barcelona
Who may be able to join
- paroxysmal or early persistent (max. 3 months) atrial fibrillation
- scheduled for PVI-only catheter ablation
Who cannot join
- long-standing persistent atrial fibrillation
- previous left atrial ablation
- claustrophobia preventing CMR
- sever renal insufficiency (GFR >30 ml/min)
- gadolinium contrast allergy
- presence of implantable devices not compatible with magnetic resonance
- pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic, University of Barcelona
Barcelona, Catalonia, 08036
Lluis Mont, +34 93 2271778, LMONT@clinic.cat
Neus Portella, +34 93 2271778, nportella@clinic.cat
About this study
Official title: Effect of Very High Power-short Duration Ablation on Lesion Contiguity in Pulmonary Vein Isolation as Assessed by Late Gadolinium Enhancement Cardiovascular Magnetic Resonance
This observational trial investigates the effect of very high power-short duration radiofrequency ablation on lesion contiguity as assessed by late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR). Patients with paroxysmal or early persistent atrial fibrillation (AF) scheduled for pulmonary vein isolation (PVI) undergo point-by-point ablation using the QDOT micro catheter applying Qmode+ (90W over 4 seconds). All patients receive an LGE-CMR 3 months after the procedure for ablation lesion assessment. Contiguity of LGE-CMR-detected ablation lesions will be compared with a matched control group of patients that have undergone PVI accomplished by ablation index-guided ablation with 40 W following the CLOSE protocol.
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Very high power-short duration ablation | PVI performed by point-by-point very high power-short duration radiofrequency ablation (QDOT-micro catheter, Biosense Webster; Qmode+; 90 W; 4 sec; target intertag distances: posterior wall 4 mm, proximity of the esophagus 5 mm, all other 3 mm) | |
| Matched control group conventional ablation | PVI performed by conventional point-by-point radiofrequency ablation (40 W; ablation index-guided: posterior wall 350, other 450; target intertag distance 3.0 - 5.0 mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ablation lesion contiguity as assessed by LGE-CMR
Proportion of the circumferential ablation line covered by LGE (%)
Measured: LGE-CMR at 3 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start10 Mar 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Till F. Althoff, University of Barcelona
- Investigators
- Till F. Althoff, M.D., Principal investigator, Hospital Clinic, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368610
- Sponsor's protocol ID
- QDOT-MRI
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 10 May 2022
- 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 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Very High Power-short Duration Ablation on Lesion Contiguity in Pulmonary Vein Isolation as Assessed by Late Gadolinium Enhancement Cardiovascular Magnetic Resonance
- ClinicalTrials.gov ID
- NCT05368610
- Acronym / sponsor ID
- QDOT-MRI
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 10 May 2022 (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.
This observational trial investigates the effect of very high power-short duration radiofrequency ablation on lesion contiguity as assessed by late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR). Patients with paroxysmal or early persistent atrial fibrillation (AF) scheduled for pulmonary vein isolation (PVI) undergo point-by-point ablation using the QDOT micro catheter applying Qmode+ (90W over 4 seconds). All patients receive an LGE-CMR 3 months after the procedure for ablation lesion assessment. Contiguity of LGE-CMR-detected ablation lesions will be compared with a matched control group of patients that have undergone PVI accomplished by ablation index-guided ablation with 40 W following the CLOSE protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very high power-short duration ablation | – | –PVI performed by point-by-point very high power-short duration radiofrequency ablation (QDOT-micro catheter, Biosense Webster; Qmode+; 90 W; 4 sec; target intertag distances: posterior wall 4 mm, proximity of the esophagus 5 mm, all other 3 mm) |
| Matched control group conventional ablation | – | –PVI performed by conventional point-by-point radiofrequency ablation (40 W; ablation index-guided: posterior wall 350, other 450; target intertag distance 3.0 - 5.0 mm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for PVI-only catheter ablation at Hospital Clinic, University of Barcelona
Key inclusion criteria (2 listed)
- paroxysmal or early persistent (max. 3 months) atrial fibrillation
- scheduled for PVI-only catheter ablation
Key exclusion criteria (7 listed)
- long-standing persistent atrial fibrillation
- previous left atrial ablation
- claustrophobia preventing CMR
- sever renal insufficiency (GFR >30 ml/min)
- gadolinium contrast allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ablation lesion contiguity as assessed by LGE-CMR
Time frame: LGE-CMR at 3 months post-ablation
Proportion of the circumferential ablation line covered by LGE (%)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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. This study is not recruiting at the moment.
Till F. Althoff, M.D. principal investigator
Hospital Clinic, University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Barcelona at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Till F. Althoff, M.D. (+34932271778, althoff@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ablation lesion contiguity as assessed by LGE-CMR (time frame: LGE-CMR at 3 months post-ablation). 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 10 May 2022.