Atrial FibrillationNCT04053361
Catheter Ablation of Atrial Fibrillation in Patients With Pulmonary Hypertension Hypertension: a Randomised Study
A study testing Catheter ablation in people with Atrial Fibrillation and Pulmonary Hypertension, run by General University Hospital, Prague at 3 sites in Czechia.
Trial summary
Atrial fibrillation (AF) and atrial tachycardia (AT), including type I atrial flutter, are frequently observed in patients with pulmonary hypertension (PH). Catheter ablation of AF / AT has been established as an effective treatment option in selected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Pulmonary Hypertension
- 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
- 76 participants
- Where
- 3 sitesCzechia
- Study dates
- 1 May 2018to 31 Dec 2022
- 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
- Pre-capillary PH (PAMP ≥25 mmHg; PAWP ≤15 mmHg) or combined post- a pre-capillary PH (PAMP ≥25 mmHg; PAWP >15 mmHg; DPG ≥7 mmHg and/or PVR >3 W.u.) of any etiology.
Who cannot join
- Complex congenital heart defects (corrected or uncorrected)
- Isolated post-capillary PH (PAMP ≥25 mmHg; PAWP >15 mmHg; DPG <7 mmHg and/or PVR ≤ 3W.u.)
- Previous catheter ablation for AF / AT / AFL
- Previous or scheduled cardiac surgery-
- NYHA Class IV, cardiogenic shock
- Life expectancy <1 year
- Non-compliance
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
FN Olomouc
Olomouc, 77900
IKEM
Prague, 10000
General University Hospital in Prague
Prague, 12808
About this study
Official title: Catheter Ablation of Atrial Fibrillation/Tachycardia in Patients With Pulmonary Hypertension: a Randomised Study
Atrial fibrillation (AF) and atrial tachycardia (AT), including type I atrial flutter, are frequently observed in patients with pulmonary hypertension (PH). Catheter ablation of AF / AT has been established as an effective treatment option in selected patients. However, little is known about the efficacy and safety of this approach in patients with PH. It has also been shown that considerable proportion of patients with PH after acutely successful catheter ablation suffer from the recurrence of clinical or newly manifested arrhythmia. We propose a prospective study to compare two ablation strategies in a randomized fashion: radiofrequency catheter ablation targeting only the clinical arrhythmia versus more extensive substrate-based catheter ablation. This project will investigate the clinical outcome of patients with pulmonary hypertension and symptomatic atrial fibrillation / tachycardia who will be randomly allocated to selective versus complex radiofrequency catheter ablation of arrhythmogenic substrate.
- Conditions
- Atrial Fibrillation, Pulmonary Hypertension
- Being tested
- Catheter ablation
- Keywords
- Atrial Fibrillation, Pulmonary Hypertension, Catheter Ablation
- Medical subject headings
- Atrial Fibrillation, Hypertension, Pulmonary
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 of atrial fibrillation or atrial tachykardie related to atrial fibrillation with use of radiofrequency energy.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Clinical ablation | Active comparator | * Cinical arrhythmia is fairly documented AF, pulmonary vein isolation will be performed. If AF persists after this step, electrical cardioversion will be performed.
* If clinical arrhythmia is fairly documented type 1 AFL, cavo-tricuspid isthmus ablation will be performed.
* If clinical arrhythmia is AT, it will be induced (if not persistent), identified by means of activation and/or entrainment mapping, and ablated.
* If clinical arrhythmia is AT that is non-inducible during EP study, no ablation will be done.
* If other incidental (or induced) AT is observed that can be qualified as non-clinical it will not be targeted unless considered important to ablate at discretion of operator.
* No induction protocols for other, on top of already ablated, arrhythmias will be attempted. Receives: Procedure: Catheter ablation |
| Group B: Clinical plus substrate-based ablation | Experimental | - The initial ablation steps will be identical to those in patients from Group A.
Supplemental ablation will consist of:
* Empirical lesion set within right atrium: superior vena cava isolation, posteroseptal bicaval line, and cavo-tricuspid isthmus ablation (if not already ablated)
AND
* Homogenization of low-voltage zones (if any) in left / right atrium defined by bipolar voltage <0.5 mV in sinus rhythm or <0.2 mV in AF / AT. The threshold can be adapted in severely diseased atria to delineate reasonably smaller zones (<20% of atrial surface) achievable to ablate.
* Arrhythmia induction protocol by10-second burst atrial pacing with cycle length of 300 ms decremented by 10 ms up to atrial refractoriness or cycle length of 200 ms.
* Inducible ATs will be mapped and ablated if feasible. In case of inducible persistent (>5 min) AF, pulmonary vein isolation will be performed if not previously done as per protocol. Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia recurrence
Documented arrhythmia recurrence >30 s without antiarrhythmic drugs in post-blanking period after the index ablation
Measured: 3 months
Secondary outcomes (6)
On-drugs arrhythmia recurrence
Documented on-drugs arrhythmia recurrence
Measured: 3 months
Symptoms of arrhythmia
Symptoms of arrhythmia by questionare
Measured: 3 months
Change in Quality of life
EQ5D
Measured: 6 months
Mortality
Mortality of any cause
Measured: 3 months
Procedure-related complication rate
Complications related to catheter ablation
Measured: 1 day (Once)
Reablation
Number of repeat catheter ablations if symptoms are ongoing
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 May 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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
- Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stepan Havranek, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053361
- Sponsor's protocol ID
- GH-18-02-00027-0-202
- Status last verified
- Feb 2024
- First submitted
- 28 Jun 2019
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Havranek S, Fingrova Z, Skala T, Reichenbach A, Dusik M, Jansa P, Ambroz D, Dytrych V, Klimes D, Hutyra M, Kautzner J, Linhart A, Wichterle D. Catheter ablation of atrial fibrillation and atrial tachycardia in patients with pulmonary hypertension: a randomized study. Europace. 2023 May 19;25(5):euad131. doi: 10.1093/europace/euad131.
PubMed 37178136
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation of Atrial Fibrillation/Tachycardia in Patients With Pulmonary Hypertension: a Randomised Study
- ClinicalTrials.gov ID
- NCT04053361
- Acronym / sponsor ID
- GH-18-02-00027-0-202
- Conditions
- Atrial Fibrillation, Pulmonary Hypertension
- Keywords
- Atrial Fibrillation, Pulmonary Hypertension, Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Aug 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.
Atrial fibrillation (AF) and atrial tachycardia (AT), including type I atrial flutter, are frequently observed in patients with pulmonary hypertension (PH). Catheter ablation of AF / AT has been established as an effective treatment option in selected patients. However, little is known about the efficacy and safety of this approach in patients with PH. It has also been shown that considerable proportion of patients with PH after acutely successful catheter ablation suffer from the recurrence of clinical or newly manifested arrhythmia. We propose a prospective study to compare two ablation strategies in a randomized fashion: radiofrequency catheter ablation targeting only the clinical arrhythmia versus more extensive substrate-based catheter ablation. This project will investigate the clinical outcome of patients with pulmonary hypertension and symptomatic atrial fibrillation / tachycardia who will be randomly allocated to selective versus complex radiofrequency catheter ablation of arrhythmogenic substrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Clinical ablation | Active comparator | Procedure: Catheter ablation* Cinical arrhythmia is fairly documented AF, pulmonary vein isolation will be performed. If AF persists after this step, electrical cardioversion will be performed. * If clinical arrhythmia is fairly documented type 1 AFL, cavo-tricuspid isthmus ablation will be performed. * If clinical arrhythmia is AT, it will be induced (if not persistent), identified by means of activation and/or entrainment mapping, and ablated. * If clinical arrhythmia is AT that is non-inducible during EP study, no ablation will be done. * If other incidental (or induced) AT is observed that can be qualified as non-clinical it will not be targeted unless considered important to ablate at discretion of operator. * No induction protocols for other, on top of already ablated, arrhythmias will be attempted. |
| Group B: Clinical plus substrate-based ablation | Experimental | Procedure: Catheter ablation- The initial ablation steps will be identical to those in patients from Group A. Supplemental ablation will consist of: * Empirical lesion set within right atrium: superior vena cava isolation, posteroseptal bicaval line, and cavo-tricuspid isthmus ablation (if not already ablated) AND * Homogenization of low-voltage zones (if any) in left / right atrium defined by bipolar voltage <0.5 mV in sinus rhythm or <0.2 mV in AF / AT. The threshold can be adapted in severely diseased atria to delineate reasonably smaller zones (<20% of atrial surface) achievable to ablate. * Arrhythmia induction protocol by10-second burst atrial pacing with cycle length of 300 ms decremented by 10 ms up to atrial refractoriness or cycle length of 200 ms. * Inducible ATs will be mapped and ablated if feasible. In case of inducible persistent (>5 min) AF, pulmonary vein isolation will be performed if not previously done as per protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pre-capillary PH (PAMP ≥25 mmHg; PAWP ≤15 mmHg) or combined post- a pre-capillary PH (PAMP ≥25 mmHg; PAWP >15 mmHg; DPG ≥7 mmHg and/or PVR >3 W.u.) of any etiology.
Key exclusion criteria (7 listed)
- Complex congenital heart defects (corrected or uncorrected)
- Isolated post-capillary PH (PAMP ≥25 mmHg; PAWP >15 mmHg; DPG <7 mmHg and/or PVR ≤ 3W.u.)
- Previous catheter ablation for AF / AT / AFL
- Previous or scheduled cardiac surgery-
- NYHA Class IV, cardiogenic shock
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 of atrial fibrillation or atrial tachykardie related to atrial fibrillation with use of radiofrequency energy. | Procedure or surgery | Group A: Clinical ablation, Group B: Clinical plus substrate-based ablation |
Primary outcome
Arrhythmia recurrence
Time frame: 3 months
Documented arrhythmia recurrence >30 s without antiarrhythmic drugs in post-blanking period after the index ablation
6 secondary outcomes
On-drugs arrhythmia recurrence
Time frame: 3 months
Symptoms of arrhythmia
Time frame: 3 months
Change in Quality of life
Time frame: 6 months
Mortality
Time frame: 3 months
Procedure-related complication rate
Time frame: 1 day (Once)
Reablation
Time frame: 3 months
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 26 Feb 2024.
- Results publication: PubMed 37178136Havranek S, Fingrova Z, Skala T, Reichenbach A, Dusik M, Jansa P, Ambroz D, Dytrych V, Klimes D, Hutyra M, Kautzner J, Linhart A, Wichterle D. Catheter ablation of atrial fibrillation and atrial tachycardia in patients with pulmonary hypertension: a randomized study. Europace. 2023 May 19;25(5):euad131. doi: 10.1093/europace/euad131.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 and Pulmonary Hypertension, run by General University Hospital, Prague at 3 sites 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 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: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Arrhythmia recurrence (time frame: 3 months). 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 NCT04053361, 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 26 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.