Cardiac ArrhythmiasNCT04361006
Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways
A study testing Radiofrequency (RF) and Cryotherapy (CRYO) in people with Cardiac Arrhythmias and Accessory Pathway, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
A randomized pilot study to evaluate safety and efficacy endpoints for treatment of para-hisian accessory pathways according to two different strategies of lesion formation. These patients will be divided into 2 groups with different strategies of treatment: group 1 treated with radiofrequency (RF) ablation, group 2… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cardiac Arrhythmias, Accessory Pathway, Wolf Parkinson White Syndrome
- What is being tested?
- Radiofrequency (RF) and Cryotherapy (CRYO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 1 Feb 2021
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with para-hisian accessory pathways, diagnosed by electrophysiological study (EPS), with indication of invasive treatment according to current guidelines. Patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form.
Who cannot join
- Previous cryotherapy ablation;
- Previous extensive radiofrequency ablation (including aortic cusp mapping);
- Age below twelve years;
- Severe coagulation disorder;
- Pregnancy;
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
São Paulo, São Paulo, 05403010
About this study
Official title: Safety and Efficacy of Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways: a Randomized Comparative Trial
A randomized pilot study to evaluate safety and efficacy endpoints for treatment of para-hisian accessory pathways according to two different strategies of lesion formation.
These patients will be divided into 2 groups with different strategies of treatment: group 1 treated with radiofrequency (RF) ablation, group 2 with cryotherapy (CRYO).
The primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.
Read the detailed description
This is a randomized study on the safety and efficacy for percutaneous ablation of para-hisian accessory pathways according to two different modalities: radiofrequency (RF) or cryotherapy.
Thirty patients with symptomatic or high-risk para-hisian accessory pathways, documented by previous electrophysiological study (EPS), referred to percutaneous catheter ablation, will be enrolled in this trial.
After informed consent, these patients will be randomized in 2 groups with different current established strategies of invasive treatment. Group I: electrophysiological mapping and ablation with radiofrequency (RF) focal lesion formation.
Group II: electrophysiological mapping and ablation with cryotherapy (CRYO) focal lesion formation.
The primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.
- Being tested
- Radiofrequency (RF), Cryotherapy (CRYO)
- Keywords
- para-hisian, radiofrequency, cryoablation, accessory pathway, electrophysiology
- Medical subject headings
- Arrhythmias, Cardiac, Pre-Excitation Syndromes, Wolff-Parkinson-White Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency (RF)Device
Will be evaluated if percutaneous radiofrequency catheter ablation is superior to cryotherapy as treatment modality of para-hisian accessory pathways.
Cryotherapy (CRYO)Device
Will be evaluated if percutaneous cryotherapy catheter ablation is superior to radiofrequency as treatment modality of para-hisian accessory pathways.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency (RF) | Active comparator | Twenty patients will be allocated to this group, which will be treated using radiofrequency (RF) ablation technique. Receives: Device: Radiofrequency (RF) |
| Cryotherapy (CRYO) | Active comparator | Twenty patients will be allocated to this group, which will be treated using Cryotherapy (CRYO) ablation technique. Receives: Device: Cryotherapy (CRYO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year recurrence rate
Recurrence rate of accessory pathway conduction, as assessed by follow-up Clinical recording and event monitoring external device (Holter/Looper).
Measured: One year
Secondary outcomes (2)
Immediate success rate
Mensuration of immediate success at the EP lab after ablation therapy is finished, defined by elimination of accessory pathway and/or noninducibility of arrhythmias at the end of procedure, as assessed by standard electrophysiological maneuvers.
If an evidence of accessory pathway conduction still remains at the end of procedure it will count as an unsuccessful case.
Does not take into account recurrences after the end of procedure, e.g. in the hospital ward before discharge.
Measured: Time span between vein puncture (start of procedure) and sheath removal (end of procedure), comparing with baseline rhythm
Rate of atrioventricular block
Safety outcome of any permanent atrioventricular (AV) block that occurred immediately after ablation start or during hospital admission.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Oct 2018
- Primary completion28 Feb 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute
- Responsible party
- Principal investigator, Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital
- Investigators
- Mauricio I Scanavacca, MD, PhD, Study chair, Instituto do coração - HC/FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361006
- Sponsor's protocol ID
- 4446/16/112
- Other IDs
- U1111-1250-5793
- Status last verified
- May 2023
- First submitted
- 19 Apr 2020
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways: a Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT04361006
- Acronym / sponsor ID
- 4446/16/112
- Keywords
- para-hisian, radiofrequency, cryoablation, accessory pathway, electrophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- InCor Heart Institute
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 24 Apr 2020 (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.
A randomized pilot study to evaluate safety and efficacy endpoints for treatment of para-hisian accessory pathways according to two different strategies of lesion formation.
These patients will be divided into 2 groups with different strategies of treatment: group 1 treated with radiofrequency (RF) ablation, group 2 with cryotherapy (CRYO).
The primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.
Detailed description
This is a randomized study on the safety and efficacy for percutaneous ablation of para-hisian accessory pathways according to two different modalities: radiofrequency (RF) or cryotherapy.
Thirty patients with symptomatic or high-risk para-hisian accessory pathways, documented by previous electrophysiological study (EPS), referred to percutaneous catheter ablation, will be enrolled in this trial.
After informed consent, these patients will be randomized in 2 groups with different current established strategies of invasive treatment. Group I: electrophysiological mapping and ablation with radiofrequency (RF) focal lesion formation.
Group II: electrophysiological mapping and ablation with cryotherapy (CRYO) focal lesion formation.
The primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency (RF) | Active comparator | Device: Radiofrequency (RF)Twenty patients will be allocated to this group, which will be treated using radiofrequency (RF) ablation technique. |
| Cryotherapy (CRYO) | Active comparator | Device: Cryotherapy (CRYO)Twenty patients will be allocated to this group, which will be treated using Cryotherapy (CRYO) ablation technique. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with para-hisian accessory pathways, diagnosed by electrophysiological study (EPS), with indication of invasive treatment according to current guidelines. Patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form.
Key exclusion criteria (6 listed)
- Previous cryotherapy ablation;
- Previous extensive radiofrequency ablation (including aortic cusp mapping);
- Age below twelve years;
- Severe coagulation disorder;
- Pregnancy;
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 |
|---|---|---|
| Radiofrequency (RF)Will be evaluated if percutaneous radiofrequency catheter ablation is superior to cryotherapy as treatment modality of para-hisian accessory pathways. | Device | Radiofrequency (RF) |
| Cryotherapy (CRYO)Will be evaluated if percutaneous cryotherapy catheter ablation is superior to radiofrequency as treatment modality of para-hisian accessory pathways. | Device | Cryotherapy (CRYO) |
Primary outcome
One-year recurrence rate
Time frame: One year
Recurrence rate of accessory pathway conduction, as assessed by follow-up Clinical recording and event monitoring external device (Holter/Looper).
2 secondary outcomes
Immediate success rate
Time frame: Time span between vein puncture (start of procedure) and sheath removal (end of procedure), comparing with baseline rhythm
Rate of atrioventricular block
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrhythmias
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
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
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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.
Mauricio I Scanavacca, MD, PhD study chair
Instituto do coração - HC/FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency (RF) and Cryotherapy (CRYO) in people with Cardiac Arrhythmias and Accessory Pathway, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 6 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: finished, as of the sponsor's last update on 19 May 2023. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year recurrence rate (time frame: One year). 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 19 May 2023.