Atrial FibrillationCDAFNCT03332862
Continuous Versus Discontinuous Design of Encircling Lesions During Ablation for Atrial Fibrillation
A study testing catheter ablation in people with Atrial Fibrillation, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
Acute efficacy of point-by-point radiofrequency ablation for pulmonary vein isolation in patients with atrial fibrillation are comparable independantly of the ablation strategy (continous versus discontinuous ablation) under the same condition of power delivery. 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?
- catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Sep 2017to 31 Jan 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for paroxysmal atrial fibrillation treatment.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine
Prague
Bashar Aldhoon, MD,PhD
About this study
Official title: Acute Efficacy of Point-by-point Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation: a Randomized Comparison of Continuous Versus Discontinuous Design of Encircling Lesions
Acute efficacy of point-by-point radiofrequency ablation for pulmonary vein isolation in patients with atrial fibrillation are comparable independantly of the ablation strategy (continous versus discontinuous ablation) under the same condition of power delivery.
Read the detailed description
The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Durable PVI is cornerstone for long-term freedom of AF. In one previous study continuous ablation was suggested to be more efficient in durable PVI. However, this hypothesis has not been proven in randomized fashion.
The current study is to confirm whether continuous versus discontinuous design of encircling lesions are comparable under the same conditions of power delivery.
The study design is a two-centre prospective randomized trial to compare the acute efficacy by using the above described approaches.
- Conditions
- Atrial Fibrillation
- Being tested
- catheter ablation
- Keywords
- Catheter Ablation, Atrial Fibrillation, Contact Force, Continuous 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.
catheter ablationProcedure or surgery
catheter ablation for atrial fibrillation treatment
| Study group | Role | What they receive |
|---|---|---|
| Discontinuous ablation | Experimental | perform discontinuous ablation of ipsilateral pulmunary veins. Receives: Procedure: catheter ablation |
| Continuous ablation | Active comparator | perform continuous ablation of ipsilateral pulmunary veins. Receives: Procedure: catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined unsuccessful PVI or PV reconnection
Combined unsuccessfuk PVI after completeing the primary lesion set or PV reconnection during the waiting time
Measured: 30 min after ablation
Secondary outcomes (1)
Early pulmunary veins reconnection
Early pulmunary veins reconnection within the first 10 min after PVI
Measured: 10 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start15 Sep 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Collaborators
- Charles University, Czech Republic, 3rd Department of Internal Medicine - Cardiology
- Responsible party
- Principal investigator, Bashar Aldhoon, Institute for Clinical and Experimental Medicine
- Investigators
- Bashar Aldhoon, MD, PhD, Principal investigator, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332862
- Sponsor's protocol ID
- G-17-06-22
- Acronym
- CDAF
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aldhoon B, Peichl P, Osmancik P, Konecny P, Kautzner J, Wichterle D. Acute efficacy of contiguous versus temporally discontiguous point-by-point radiofrequency pulmonary vein isolation in patients with paroxysmal atrial fibrillation: a randomized study. J Interv Card Electrophysiol. 2022 Sep;64(3):661-667. doi: 10.1007/s10840-021-01113-9. Epub 2022 Jan 6.
PubMed 34988847
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Efficacy of Point-by-point Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation: a Randomized Comparison of Continuous Versus Discontinuous Design of Encircling Lesions
- ClinicalTrials.gov ID
- NCT03332862
- Acronym / sponsor ID
- CDAF / G-17-06-22
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter Ablation, Atrial Fibrillation, Contact Force, Continuous Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Collaborators
- Charles University, Czech Republic, 3rd Department of Internal Medicine - Cardiology
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Jan 2018 (estimated)
- First posted
- 6 Nov 2017 (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.
Acute efficacy of point-by-point radiofrequency ablation for pulmonary vein isolation in patients with atrial fibrillation are comparable independantly of the ablation strategy (continous versus discontinuous ablation) under the same condition of power delivery.
Detailed description
The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Durable PVI is cornerstone for long-term freedom of AF. In one previous study continuous ablation was suggested to be more efficient in durable PVI. However, this hypothesis has not been proven in randomized fashion.
The current study is to confirm whether continuous versus discontinuous design of encircling lesions are comparable under the same conditions of power delivery.
The study design is a two-centre prospective randomized trial to compare the acute efficacy by using the above described approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discontinuous ablation | Experimental | Procedure: catheter ablationperform discontinuous ablation of ipsilateral pulmunary veins. |
| Continuous ablation | Active comparator | Procedure: catheter ablationperform continuous ablation of ipsilateral pulmunary veins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for paroxysmal atrial fibrillation treatment.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| catheter ablationcatheter ablation for atrial fibrillation treatment | Procedure or surgery | Continuous ablation, Discontinuous ablation |
Primary outcome
Combined unsuccessful PVI or PV reconnection
Time frame: 30 min after ablation
Combined unsuccessfuk PVI after completeing the primary lesion set or PV reconnection during the waiting time
1 secondary outcome
Early pulmunary veins reconnection
Time frame: 10 min.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 34988847Aldhoon B, Peichl P, Osmancik P, Konecny P, Kautzner J, Wichterle D. Acute efficacy of contiguous versus temporally discontiguous point-by-point radiofrequency pulmonary vein isolation in patients with paroxysmal atrial fibrillation: a randomized study. J Interv Card Electrophysiol. 2022 Sep;64(3):661-667. doi: 10.1007/s10840-021-01113-9. Epub 2022 Jan 6.
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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. This study is not recruiting at the moment.
Bashar Aldhoon, MD, PhD principal investigator
Institute for Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheter ablation in people with Atrial Fibrillation, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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 1 inclusion and 1 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 6 Nov 2017. 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 Czechia. 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 Bashar Aldhoon, MD, PhD (+420739528025, baaĺ@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined unsuccessful PVI or PV reconnection (time frame: 30 min after ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03332862, which also lists 1 linked publication.
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 6 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.