Atrial FibrillationNCT04337567
Radiofrequency Ablation Versus Balloon Cryoablation in Elderly Patients With Atrial Fibrillation
A study testing radiofrequency ablation and ballon cryoablation in people with Atrial Fibrillation, run by Vivantes Netzwerk für Gesundheit GmbH at 1 site in Germany.
Trial summary
This study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- radiofrequency ablation and ballon cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to 31 Jan 2024
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation
- At the day of their inclusion in the study the patients have to have completed the 75th year of life
Who cannot join
- Dementia
- Presence of left atrial thrombus
- Left atrial volume> 50 ml/m²
- Renal failure (GFR≤ 30 ml/min)
- Comorbidity with an expected survival of 12 months or less.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Vivantes Klinikum Neukölln
Berlin
Charalampos Kriatselis, MD, 0049 30 15140663741, charalampos.kriatselis@vivantes.de
Michael Distler, MD, 0049 30 130 142014, michael.distler@vivantes.de
About this study
Official title: A Prospective Randomized Trial for the Comparison of Procedural Characteristics and Long-term Effects of Radiofrequency Ablation and Balloon Cryoablation in Elderly Patients With Atrial Fibrillation
This study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older.
Read the detailed description
Radiofrequency and cryoballon ablation have been shown to be comparable to each other in terms of safety and effectivity in patients with atrial fibrillation. However, elderly patients have been underrepresented in the previous studies. The number of older patients with atrial fibrillation is high and the number of who undergo an ablation procedure for atrial fibrillation increases steadily. This prospective randomized trial compares the effectivity (recurrency of atrial arrhythmias) and periprocedural characteristics of the two established ablation methods in patients who are 75 years or older.
- Conditions
- Atrial Fibrillation
- Being tested
- radiofrequency ablation, ballon cryoablation
- Keywords
- ablative treatment of atrial fibrillation, ballon cryoablation, radiofrequency ablation, 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.
radiofrequency ablationProcedure or surgery
ablative treatment as allocated to radiofrequency ablation
ballon cryoablationProcedure or surgery
ablative treatment as allocated to ballon cryoablation
| Study group | Role | What they receive |
|---|---|---|
| Patients over 75 years_RF ablation | Active comparator | Patients randomized to receive pulmonary vein isolation by means of radiofrequency ablation. Receives: Procedure: radiofrequency ablation |
| Patients over 75 years_ballon cryoablation | Active comparator | Patients randomized to receive pulmonary vein isolation by means of ballon cryoablation. Receives: Procedure: ballon cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial arrhythmia recurrence
Number of Participants with recurrence of any atrial arrhythmia with a duration of 30 sec or longer 12 months after the ablative treatment
Measured: 1 year
Secondary outcomes (8)
procedural duration
Duration of the whole procedure [min] inclusive preparation (from entrance to the EP lab till exit from the EP lab)
Measured: periprocedural
time to wake-up after propofol withdrawal
Time from withdrawal of propofole till patient awake and fully oriented (time, place, person)
Measured: periprocedural
contrast medium dosis
Amount of contrast medium used
Measured: periprocedural
Propofoldosis
Propofoldosis needed for sedation
Measured: periprocedural
groin complications
Number of Participants in each randomisation arm with groin complications (hematoma, av fistel, Aneuryma spurium, infection).
Measured: up to 3 months after dismission from the hospital
Neurological complications
Number of Participants in each randomisation arm with transient ischemic attack, cerebral insult, cerebral haemorrhage
Measured: 1 year
vascular complications
Number of Participants in each randomisation arm with deep vein thrombosis, peripheral embolism.
Measured: 1 year
duration of hospital staying [days]
duration of hospital staying: from admission till discharge in days
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Mar 2020
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2024 (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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivantes Netzwerk für Gesundheit GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charalampos Kriatselis, Vivantes Netzwerk für Gesundheit GmbH
- Investigators
- Charalampos Kriatselis, MD, Principal investigator, Vivantes Clinic Neukölln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337567
- Sponsor's protocol ID
- RS_RFCR_ELDPA_0120
- Status last verified
- Apr 2020
- First submitted
- 8 Mar 2020
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial for the Comparison of Procedural Characteristics and Long-term Effects of Radiofrequency Ablation and Balloon Cryoablation in Elderly Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04337567
- Acronym / sponsor ID
- RS_RFCR_ELDPA_0120
- Conditions
- Atrial Fibrillation
- Keywords
- ablative treatment of atrial fibrillation, ballon cryoablation, radiofrequency ablation, elderly patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Vivantes Netzwerk für Gesundheit GmbHUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 7 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.
This study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older.
Detailed description
Radiofrequency and cryoballon ablation have been shown to be comparable to each other in terms of safety and effectivity in patients with atrial fibrillation. However, elderly patients have been underrepresented in the previous studies. The number of older patients with atrial fibrillation is high and the number of who undergo an ablation procedure for atrial fibrillation increases steadily. This prospective randomized trial compares the effectivity (recurrency of atrial arrhythmias) and periprocedural characteristics of the two established ablation methods in patients who are 75 years or older.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients over 75 years_RF ablation | Active comparator | Procedure: radiofrequency ablationPatients randomized to receive pulmonary vein isolation by means of radiofrequency ablation. |
| Patients over 75 years_ballon cryoablation | Active comparator | Procedure: ballon cryoablationPatients randomized to receive pulmonary vein isolation by means of ballon cryoablation. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation
- At the day of their inclusion in the study the patients have to have completed the 75th year of life
Key exclusion criteria (5 listed)
- Dementia
- Presence of left atrial thrombus
- Left atrial volume> 50 ml/m²
- Renal failure (GFR≤ 30 ml/min)
- Comorbidity with an expected survival of 12 months or less.
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 ablationablative treatment as allocated to radiofrequency ablation | Procedure or surgery | Patients over 75 years_RF ablation |
| ballon cryoablationablative treatment as allocated to ballon cryoablation | Procedure or surgery | Patients over 75 years_ballon cryoablation |
Primary outcome
atrial arrhythmia recurrence
Time frame: 1 year
Number of Participants with recurrence of any atrial arrhythmia with a duration of 30 sec or longer 12 months after the ablative treatment
8 secondary outcomes
procedural duration
Time frame: periprocedural
time to wake-up after propofol withdrawal
Time frame: periprocedural
contrast medium dosis
Time frame: periprocedural
Propofoldosis
Time frame: periprocedural
groin complications
Time frame: up to 3 months after dismission from the hospital
Neurological complications
Time frame: 1 year
vascular complications
Time frame: 1 year
duration of hospital staying [days]
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Charalampos Kriatselis, MD principal investigator
Vivantes Clinic Neukölln
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 ablation and ballon cryoablation in people with Atrial Fibrillation, run by Vivantes Netzwerk für Gesundheit GmbH at 1 site in Germany.
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 5 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 7 Apr 2020. 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 Germany. 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 Charalampos Kriatselis, MD (0049 30 15140663741, charalampos.kriatselis@vivantes.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial arrhythmia recurrence (time frame: 1 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 7 Apr 2020.