Atrial Fibrillation ParoxysmalPhase 4PVACNCT04023461
Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
A Phase 4 study testing PVAC GOLD catheter ablation in people with Atrial Fibrillation Paroxysmal and Cardiac Arrythmias, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
It is a prospective, randomized and double-blind clinical trial involving an invasive technique for isolation of pulmonary veins (PVAC gold) in relation to clinical treatment during an one year of segment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation Paroxysmal, Cardiac Arrythmias
- What is being tested?
- PVAC GOLD catheter ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Jun 2017to 3 Jun 2022
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Indication for isolation of pulmonary veins
- Age >= 65 years old
- Association with the following characteristics:
- Symptomatic Atrial Fibrillation;
- Sinusal Rhythm maintenance failure for at least 1 Antiarrythmic Drugs;
- Diagnosis of Atrial Fibrilation on resting eletrocardiogram and/or 24h Holter.
Who cannot join
- Prior Atrial Fibrillation ablation;
- Atrial Fibrillation permanent and/or persistent;
- Left atrial size > 55 mm;
- Mechanical prothetic mitral valve replacement;
- Presence of atrial thrombus;
- Cardiac invasive procedure < 90 days;
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- Cerebral embolism < 6 months;
- Hypertrophic cardiomyopathy;
- Contraindications to antiocoagulation and cerebral MRI.
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
It is a prospective, randomized and double-blind clinical trial involving an invasive technique for isolation of pulmonary veins (PVAC gold) in relation to clinical treatment during an one year of segment. The patients included have paroxysmal atrial fibrillation (aged 65 years and older) refractory to antiarrhythmic treatments that do not have structural and / or ischemic heart diseases. This trial employed quality of life scores prior to the study and during the sixth and twelfth month of the segment, electrocardiograms and holter of 24 hours. The proposed imaging tests was the transesophageal echocardiogram before each procedure. The cerebral MRI was performed in the 24 hours post invasive procedure and Angio-tomography of the pulmonary veins in the 6-month segment.
Read the detailed description
Objective: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become progressively safer and more effective with advances in single-shot devices. The aim of this study was to compare catheter ablation (CA) of second-generation pulmonary vein ablation catheter (PVAC) Gold technique versus clinical treatment in elderly patients (≥ 65 years old) with symptomatic paroxysmal AF (PAF) without structural heart diseases.
Methods: Prospective randomized study that selected consecutive patients with paroxysmal atrial fibrillation older than 65 years-old in two groups: (1) PVAC ablation group and (2) antiarrhythmic drugs therapy group. Primary outcomes were AF recurrences, progression to persistent AF forms. As secondary outcomes, changes in Mini-Mental State Examination and AF Quality of Life Score were accessed.This study doesn't include payment of participants. All patients signed the informed consent.
- Conditions
- Atrial Fibrillation Paroxysmal, Cardiac Arrythmias
- Being tested
- PVAC GOLD catheter ablation
- Keywords
- Radiofrequency Ablation, Atrial Fibrilation, PVAC GOLD catheter, Elderly patients
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVAC GOLD catheter ablationDevice
Isolation of pulmonary veins using PVAC GOLD catheter.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Treatment Group | No intervention | Not described |
| Interventional Ablation Group | Experimental | Not described Receives: Device: PVAC GOLD catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation
Recurrence of atrial fibrillation during 1 year of follow-up
Measured: 1 year after ablation
Secondary outcomes (3)
Occurrence of Asymptomatic Cerebral Embolism
Occurrence of Asymptomatic Cerebral Embolism during 1 year of follow-up
Measured: 1 year of follow-up
Esophageal Ulcer
Esophageal Ulcer documented by Esophagus-gastro-duodenoscopy after ablation procedure
Measured: 24 hours after pulmonary vein isolation
Quality of Life Assessment
Quality of Life in Atrial Fibrillation Questionnaire Score
Measured: 1 year after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start29 Jun 2017
- Primary completion20 Feb 2021
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation ParoxysmalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients in clinical treatment arm had to keep on antiarrhythmic drug for AF rhythm control strategy
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital
- Investigators
- Mauricio I Scanavacca, MD, PhD, Principal investigator, Arrythmia Clinical Unit Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023461
- Sponsor's protocol ID
- 4471/16/137
- Acronym
- PVAC
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2019
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
- ClinicalTrials.gov ID
- NCT04023461
- Acronym / sponsor ID
- PVAC / 4471/16/137
- Conditions
- Atrial Fibrillation Paroxysmal, Cardiac Arrythmias
- Keywords
- Radiofrequency Ablation, Atrial Fibrilation, PVAC GOLD catheter, Elderly patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 17 Jul 2019 (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.
It is a prospective, randomized and double-blind clinical trial involving an invasive technique for isolation of pulmonary veins (PVAC gold) in relation to clinical treatment during an one year of segment. The patients included have paroxysmal atrial fibrillation (aged 65 years and older) refractory to antiarrhythmic treatments that do not have structural and / or ischemic heart diseases. This trial employed quality of life scores prior to the study and during the sixth and twelfth month of the segment, electrocardiograms and holter of 24 hours. The proposed imaging tests was the transesophageal echocardiogram before each procedure. The cerebral MRI was performed in the 24 hours post invasive procedure and Angio-tomography of the pulmonary veins in the 6-month segment.
Detailed description
Objective: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become progressively safer and more effective with advances in single-shot devices. The aim of this study was to compare catheter ablation (CA) of second-generation pulmonary vein ablation catheter (PVAC) Gold technique versus clinical treatment in elderly patients (≥ 65 years old) with symptomatic paroxysmal AF (PAF) without structural heart diseases.
Methods: Prospective randomized study that selected consecutive patients with paroxysmal atrial fibrillation older than 65 years-old in two groups: (1) PVAC ablation group and (2) antiarrhythmic drugs therapy group. Primary outcomes were AF recurrences, progression to persistent AF forms. As secondary outcomes, changes in Mini-Mental State Examination and AF Quality of Life Score were accessed.This study doesn't include payment of participants. All patients signed the informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- All patients in clinical treatment arm had to keep on antiarrhythmic drug for AF rhythm control strategy
| Arm | Type | Receives |
|---|---|---|
| Clinical Treatment Group | No intervention | – |
| Interventional Ablation Group | Experimental | Device: PVAC GOLD catheter ablation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Indication for isolation of pulmonary veins
- Age >= 65 years old
- Association with the following characteristics:
Key exclusion criteria (9 listed)
- Prior Atrial Fibrillation ablation;
- Atrial Fibrillation permanent and/or persistent;
- Left atrial size > 55 mm;
- Mechanical prothetic mitral valve replacement;
- Presence of atrial thrombus;
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 |
|---|---|---|
| PVAC GOLD catheter ablationIsolation of pulmonary veins using PVAC GOLD catheter. | Device | Interventional Ablation Group |
Primary outcome
Recurrence of atrial fibrillation
Time frame: 1 year after ablation
Recurrence of atrial fibrillation during 1 year of follow-up
3 secondary outcomes
Occurrence of Asymptomatic Cerebral Embolism
Time frame: 1 year of follow-up
Esophageal Ulcer
Time frame: 24 hours after pulmonary vein isolation
Quality of Life Assessment
Time frame: 1 year after ablation
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 12 Jul 2022.
- Individual participant dataSharing planned: No
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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 principal investigator
Arrythmia Clinical Unit Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PVAC GOLD catheter ablation in people with Atrial Fibrillation Paroxysmal and Cardiac Arrythmias, 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 6 inclusion and 9 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 12 Jul 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recurrence of atrial fibrillation (time frame: 1 year after 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 12 Jul 2022.