Atrial FibrillationPVI-SHAM-AFNCT05119231
Pulmonary Vein Isolation vs SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With AF
A study testing Pulmonary Vein Isolation in people with Atrial Fibrillation, run by University of Leipzig at 9 sites in 2 countries.
Trial summary
Being the most common arrhythmia, atrial fibrillation (AF) is a high burden of public health with an increasing prevalence in our aging population. Interventional treatment of atrial fibrillation by catheter ablation is one of the treatment pillars in the complex field of "better symptom control" based on current… 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?
- Pulmonary Vein Isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 12 Nov 2021to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 with symptomatic atrial fibrillation scheduled for pulmonary vein isolation
- Class I or class IIa indication for pulmonary vein isolation by current guidelines
- Age ≥ 18 years
- Written informed consent
Who cannot join
- History of previous pulmonary vein isolation or surgical treatment of atrial fibrillation
- Reversible causes of atrial fibrillation (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection)
- Moderate or severe valvular heart disease
- CHA2DS2-VASc-Score =0 (males) or 1 (females) or contraindication to oral anticoagulation
- Acute coronary syndrome, percutaneous coronary intervention, valve surgery or percutaneous intervention or cardiac bypass surgery and stroke within the last 3 months
- Reduced left ventricular ejection fraction < 35%
Show all 13Show fewer
- Hypertrophic obstructive cardiomyopathy
- Medical conditions limiting the expected survival to < 1 year
- Participation in any other randomized controlled trial
- Women of childbearing potential without appropriate contraceptive measures (oral contraceptives, vaginal ring, intrauterine devices, implanon, injections, partner with vasectomy) pregnant woman or woman with desire for children
- Any condition that - in the opinion of the investigator - may prevent the subject from adhering to the study protocol (e.g. history of non-compliance, drug addiction)
- Subjects under legal supervision or guardianship
- Unable to give informed consent
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites
German Heart Center of Charité University Medicine, Standort Charité Mitte
Berlin, State of Berlin
German Heart Center of Charité University Medicine, Standort DHZB
Berlin, State of Berlin
Regiomed Klinikum
Coburg, Bavaria, 96450
Heart Center Dresden University Hospital
Dresden, Saxony, 01307
University Hospital Gießen
Giessen, Hesse
Herzzentrum Leipzig
Leipzig
Universitätsklinikum Leipzig
Leipzig
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Poland1 site
Department of Cardiology, Silesian Center for Heart Diseases
Zabrze
About this study
Official title: Pulmonary Vein Isolation Versus SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With Atrial Fibrillation- a Randomised Trial - PVI-SHAM-AF
Being the most common arrhythmia, atrial fibrillation (AF) is a high burden of public health with an increasing prevalence in our aging population. Interventional treatment of atrial fibrillation by catheter ablation is one of the treatment pillars in the complex field of "better symptom control" based on current Guidelines. Catheter ablation of atrial fibrillation is based on electrical isolation of the pulmonary veins (pulmonary vein isolation: PVI) from the left atrium. The main benefit and goal of PVI in AF patients is the reduction of AF-related symptoms, resulting in an improvement of quality of life. It was shown, that catheter ablation failed to prove a difference in AF recurrence after PVI compared to medical therapy in the first 18 month of follow-up. It was also shown, that these episodes will become more asymptomatic. This raises concerns that the symptomatic improvement might be the result of a placebo effect, which will be elucidated with this study.
Read the detailed description
Being the most common arrhythmia, atrial fibrillation (AF) is a high burden of public health with an increasing prevalence in our aging population. Interventional treatment of atrial fibrillation by catheter ablation is one of the treatment pillars in the complex field of "better symptom control" based on current Guidelines. Atrial fibrillation is commonly induced and maintained by abnormal electrical impulses originating in the pulmonary veins. Catheter ablation of atrial fibrillation is based on electrical isolation of the pulmonary veins (pulmonary vein isolation: PVI) from the left atrium. This is achieved either by heating (Radiofrequency ablation) or freezing (Cryoablation) of the tissues. By inducing the formation of scar tissue, the pulmonary veins are "electrically isolated" and abnormal electrical signals are not transferred any more to the left atrium.
The main benefit and goal of PVI in AF patients is the reduction of AF-related symptoms, resulting in an improvement of quality of life. The effect was shown to be significantly higher compared with conventional medical treatment. In contrast, there is no evidence for a substantial effect of PVI on hard clinical endpoints. The recent large randomized controlled trial CABANA (Catheter ABlation vs. ANtiarrhythmic Drug Therapy for Atrial Fibrillation) did not show a reduction of the primary composite endpoint of death, disabling stroke, serious bleeding and cardiac arrest in the intention-to-treat analysis although the results are highly controversial due to the high crossover rate.
Up to now, the only patient population with evidence for a prognostic benefit of PVI in symptomatic AF are patients with a heart failure and a reduced ejection fraction (HFrEF). In the CASTLE-AF trial, a relative risk reduction for all-cause mortality of 47% was shown for HFrEF patients with AF ablation compared with conventional treatment.
7-Day Holter monitoring in patients 6 month after treatment with PVI revealed a significant increase in asymptomatic AF episodes. Furthermore, the MANTRA-PAF randomised trial (Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation) failed to prove a difference in AF recurrence after PVI compared to medical therapy in the first 18 month of follow-up.
This raises concerns that the symptomatic improvement might be the result of a placebo effect.
PVI-SHAM-AF is a prospective, double-blinded, sham-controlled, randomized, multicenter trial whose aim is to compare the effect of catheter-based ablation on patient reported outcomes based on common AF questionnaires with a sham procedure. 260 patients without previous PVI or surgical treatment of atrial fibrillation, a LVEF >35% and an indication for interventional treatment of AF with pulmonary vein isolation based on current Guidelines (ESC 2020) will be enrolled and randomized 2:1 to undergo either PVI or sham procedure. The latter will include deep sedation as performed during standard PVI treatment for at least one hour, introduction of femoral sheaths and if necessary electrical cardioversion in patients with persisting AF. No catheter will be placed within the participant. The official procedure protocol will include no details about the intervention; postinterventional care will be conducted independent of whether a catheter ablation or sham procedure was performed, based on the respective PVI protocol.
Patient will be followed up for one year with visit at 3, 6 and 12 months. Each of these visits include questionnaires for AF related Symptoms (AFEQT, SF-36 and EQ-5D); 7-Day Holter Monitoring will be performed 6 months after the procedure. Participants will be unblinded after 12 months. The primary endpoint will be the difference of AFEQT sum scores evaluated at 6 months to baseline.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary Vein Isolation, Sham-Pulmonary Vein Isolation
- Keywords
- Arrhythmias, Cardiac, Heart Disease, ECG Monitoring
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Vein IsolationProcedure or surgery
Catheter ablation (radiofrequency ablation or cryoablation) of atrial fibrillation according to local standard
Sham-Pulmonary Vein IsolationOther
Sham-Pulmonary Vein Isolation in deep sedation for at least one hour including femoral vein/artery puncture with introduction of sheaths and electrical cardioversion in presence of current atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Vein Isolation | Experimental | Pulmonary Vein Isolation (radiofrequency ablation or cryoablation) of atrial fibrillation according to local standards:
Trial participants will assigned to the PVI-arm will undergo catheter ablation within 48 hours after baseline evaluation, with the aim to achieve isolation of all pulmonary veins and restore sinus rhythm.
Dependent of the local standards an echocardiography or cardiac MRI will be performed prior to the procedure. If necessary, a transesophageal echocardiography must be performed to exclude presence of atrial thrombus.
Anticoagulation will be initiated/continued for at least 3 months after the procedure. Receives: Procedure: Pulmonary Vein Isolation |
| Sham Control Arm | Sham comparator | Sham Pulmonary Vein Isolation
Trial participants will assigned to the SHAM-arm will undergo their procedure within 48 hours after baseline evaluation. The Sham procedure will include deep sedation according to the respective PVI protocol for at least one hour, femoral vein/artery puncture with introduction of sheaths and an electrical cardioversion in presence of persistent atrial fibrillation.
Dependent of the local standards an echocardiography or cardiac MRI will be performed prior to the procedure. If necessary, a transesophageal echocardiography must be performed to exclude presence of atrial thrombus.
Anticoagulation will be initiated/continued for at least 3 months after the procedure. Receives: Other: Sham-Pulmonary Vein Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of AFEQT sum scores evaluated at 6 months
The primary objective is to show a significant improvement of AF symptoms (measured by AFEQT sum score) by PVI in comparison to sham-PVI, evaluated six months after randomisation compared to baseline.
Primary endpoint is the difference of AFEQT sum scores between the PVI and the sham-PVI arm, evaluated at 6 months after randomisation.
Measured: 6 months after randomisation compared to baseline
Secondary outcomes (8)
the longitudinal change of the AFEQT score
improvement of AF symptoms (measured by AFEQT sum score) by PVI in comparison to sham-PVI, evaluated at 3, 6 and 12 months after randomisation compared to baseline.
Measured: baseline - 3, 6 and 12 months
difference of EQ-5D scores
improvement of AF symptoms (measured by EQ-5D sum score) by PVI in comparison to sham-PVI, evaluated six months after randomisation compared to baseline.
Measured: at 6 months to baseline
difference of SF-36 scales
improvement of AF symptoms (measured by SF-36 sum score) by PVI in comparison to sham-PVI, evaluated six months after randomisation compared to baseline.
Measured: at 6 months to baseline
the change of EQ-5D over time (baseline - 3, 6 and 12 months) in a longitudinal view
improvement of AF symptoms (measured by EQ-5D sum score) by PVI in comparison to sham-PVI, evaluated at 3, 6 and 12 months after randomisation compared to baseline.
Measured: (baseline - 3, 6 and 12 months) in a longitudinal view
the change of SF-36 over time
improvement of AF symptoms (measured by SF-36 sum score) by PVI in comparison to sham-PVI, evaluated at 3, 6 and 12 months after randomisation compared to baseline.
Measured: baseline - 3, 6 and 12 months
AF burden measured as percentage of time in AF during 7 day Holter ECG monitoring
AF burden measured as percentage of time in AF during 7 day Holter ECG monitoring
Measured: at 6 months
Incidence of AF recurrence
measured by patient reports and external ECGs
Measured: at 3, 6 and 12 months
N-terminal-proBNP plasma levels
change of baseline N-terminal-proBNP plasma levels in comparison to 6 months after randomisation
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start12 Nov 2021
- Primary completion1 Jun 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Model description
- randomized, parallel group, sham-controlled and double-blinded multicenter trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Wachter, University of Leipzig
- Investigators
- Rolf Wachter, Prof. Dr., Study chair, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119231
- Sponsor's protocol ID
- PVI-SHAM-AF CIV-21-01-035584
- Acronym
- PVI-SHAM-AF
- Status last verified
- Aug 2026
- First submitted
- 3 Nov 2021
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Dilk P, Uhe T, Forkmann M, Eckardt L, Bode K, Seewoster T, Gaspar T, Neef M, Dinov B, Bacak M, Petroff D, Prettin C, Hindricks G, Laufs U, Dagres N, Wachter R. Pulmonary vein isolation versus SHAM-pulmonary vein isolation for symptomatic relief in patients with atrial fibrillation-Design and rationale of the PVI-SHAM-AF trial. Am Heart J. 2025 Dec;290:93-104. doi: 10.1016/j.ahj.2025.06.003. Epub 2025 Jun 11.
PubMed 40513974Wachter R, Haag P, Uhe T, Bacak M, Petroff D, Forkmann M, Eckardt L, Gaspar T, Dinov B, Neef M, Bode K, Seewoster T, Nedios S, Hilbert S, Lerche M, Lindemann F, Spies C, Beimel S, Paiva BTC, Hohendanner F, Tscholl V, Lenarczyk R, Bergau L, Sohns C, Prettin C, Laufs U, Hindricks G, Dagres N; PVI-SHAM-AF Investigators. Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial. Lancet. 2026 Aug 30:S0140-6736(26)01558-8. doi: 10.1016/S0140-6736(26)01558-8. Online ahead of print.
PubMed 42669307
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Isolation Versus SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With Atrial Fibrillation- a Randomised Trial - PVI-SHAM-AF
- ClinicalTrials.gov ID
- NCT05119231
- Acronym / sponsor ID
- PVI-SHAM-AF / PVI-SHAM-AF CIV-21-01-035584
- Conditions
- Atrial Fibrillation
- Keywords
- Arrhythmias, Cardiac, Heart Disease, ECG Monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 15 Nov 2021 (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.
Being the most common arrhythmia, atrial fibrillation (AF) is a high burden of public health with an increasing prevalence in our aging population. Interventional treatment of atrial fibrillation by catheter ablation is one of the treatment pillars in the complex field of "better symptom control" based on current Guidelines. Catheter ablation of atrial fibrillation is based on electrical isolation of the pulmonary veins (pulmonary vein isolation: PVI) from the left atrium. The main benefit and goal of PVI in AF patients is the reduction of AF-related symptoms, resulting in an improvement of quality of life. It was shown, that catheter ablation failed to prove a difference in AF recurrence after PVI compared to medical therapy in the first 18 month of follow-up. It was also shown, that these episodes will become more asymptomatic. This raises concerns that the symptomatic improvement might be the result of a placebo effect, which will be elucidated with this study.
Detailed description
Being the most common arrhythmia, atrial fibrillation (AF) is a high burden of public health with an increasing prevalence in our aging population. Interventional treatment of atrial fibrillation by catheter ablation is one of the treatment pillars in the complex field of "better symptom control" based on current Guidelines. Atrial fibrillation is commonly induced and maintained by abnormal electrical impulses originating in the pulmonary veins. Catheter ablation of atrial fibrillation is based on electrical isolation of the pulmonary veins (pulmonary vein isolation: PVI) from the left atrium. This is achieved either by heating (Radiofrequency ablation) or freezing (Cryoablation) of the tissues. By inducing the formation of scar tissue, the pulmonary veins are "electrically isolated" and abnormal electrical signals are not transferred any more to the left atrium.
The main benefit and goal of PVI in AF patients is the reduction of AF-related symptoms, resulting in an improvement of quality of life. The effect was shown to be significantly higher compared with conventional medical treatment. In contrast, there is no evidence for a substantial effect of PVI on hard clinical endpoints. The recent large randomized controlled trial CABANA (Catheter ABlation vs. ANtiarrhythmic Drug Therapy for Atrial Fibrillation) did not show a reduction of the primary composite endpoint of death, disabling stroke, serious bleeding and cardiac arrest in the intention-to-treat analysis although the results are highly controversial due to the high crossover rate.
Up to now, the only patient population with evidence for a prognostic benefit of PVI in symptomatic AF are patients with a heart failure and a reduced ejection fraction (HFrEF). In the CASTLE-AF trial, a relative risk reduction for all-cause mortality of 47% was shown for HFrEF patients with AF ablation compared with conventional treatment.
7-Day Holter monitoring in patients 6 month after treatment with PVI revealed a significant increase in asymptomatic AF episodes. Furthermore, the MANTRA-PAF randomised trial (Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation) failed to prove a difference in AF recurrence after PVI compared to medical therapy in the first 18 month of follow-up.
This raises concerns that the symptomatic improvement might be the result of a placebo effect.
PVI-SHAM-AF is a prospective, double-blinded, sham-controlled, randomized, multicenter trial whose aim is to compare the effect of catheter-based ablation on patient reported outcomes based on common AF questionnaires with a sham procedure. 260 patients without previous PVI or surgical treatment of atrial fibrillation, a LVEF >35% and an indication for interventional treatment of AF with pulmonary vein isolation based on current Guidelines (ESC 2020) will be enrolled and randomized 2:1 to undergo either PVI or sham procedure. The latter will include deep sedation as performed during standard PVI treatment for at least one hour, introduction of femoral sheaths and if necessary electrical cardioversion in patients with persisting AF. No catheter will be placed within the participant. The official procedure protocol will include no details about the intervention; postinterventional care will be conducted independent of whether a catheter ablation or sham procedure was performed, based on the respective PVI protocol.
Patient will be followed up for one year with visit at 3, 6 and 12 months. Each of these visits include questionnaires for AF related Symptoms (AFEQT, SF-36 and EQ-5D); 7-Day Holter Monitoring will be performed 6 months after the procedure. Participants will be unblinded after 12 months. The primary endpoint will be the difference of AFEQT sum scores evaluated at 6 months to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, parallel group, sham-controlled and double-blinded multicenter trial
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Vein Isolation | Experimental | Procedure: Pulmonary Vein IsolationPulmonary Vein Isolation (radiofrequency ablation or cryoablation) of atrial fibrillation according to local standards: Trial participants will assigned to the PVI-arm will undergo catheter ablation within 48 hours after baseline evaluation, with the aim to achieve isolation of all pulmonary veins and restore sinus rhythm. Dependent of the local standards an echocardiography or cardiac MRI will be performed prior to the procedure. If necessary, a transesophageal echocardiography must be performed to exclude presence of atrial thrombus. Anticoagulation will be initiated/continued for at least 3 months after the procedure. |
| Sham Control Arm | Sham comparator | Other: Sham-Pulmonary Vein IsolationSham Pulmonary Vein Isolation Trial participants will assigned to the SHAM-arm will undergo their procedure within 48 hours after baseline evaluation. The Sham procedure will include deep sedation according to the respective PVI protocol for at least one hour, femoral vein/artery puncture with introduction of sheaths and an electrical cardioversion in presence of persistent atrial fibrillation. Dependent of the local standards an echocardiography or cardiac MRI will be performed prior to the procedure. If necessary, a transesophageal echocardiography must be performed to exclude presence of atrial thrombus. Anticoagulation will be initiated/continued for at least 3 months after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with symptomatic atrial fibrillation scheduled for pulmonary vein isolation
- Class I or class IIa indication for pulmonary vein isolation by current guidelines
- Age ≥ 18 years
- Written informed consent
Key exclusion criteria (13 listed)
- History of previous pulmonary vein isolation or surgical treatment of atrial fibrillation
- Reversible causes of atrial fibrillation (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection)
- Moderate or severe valvular heart disease
- CHA2DS2-VASc-Score =0 (males) or 1 (females) or contraindication to oral anticoagulation
- Acute coronary syndrome, percutaneous coronary intervention, valve surgery or percutaneous intervention or cardiac bypass surgery and stroke within the last 3 months
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 |
|---|---|---|
| Pulmonary Vein IsolationCatheter ablation (radiofrequency ablation or cryoablation) of atrial fibrillation according to local standard | Procedure or surgery | Pulmonary Vein Isolation |
| Sham-Pulmonary Vein IsolationSham-Pulmonary Vein Isolation in deep sedation for at least one hour including femoral vein/artery puncture with introduction of sheaths and electrical cardioversion in presence of current atrial fibrillation | Other | Sham Control Arm |
Primary outcome
difference of AFEQT sum scores evaluated at 6 months
Time frame: 6 months after randomisation compared to baseline
The primary objective is to show a significant improvement of AF symptoms (measured by AFEQT sum score) by PVI in comparison to sham-PVI, evaluated six months after randomisation compared to baseline. Primary endpoint is the difference of AFEQT sum scores between the PVI and the sham-PVI arm, evaluated at 6 months after randomisation.
8 secondary outcomes
the longitudinal change of the AFEQT score
Time frame: baseline - 3, 6 and 12 months
difference of EQ-5D scores
Time frame: at 6 months to baseline
difference of SF-36 scales
Time frame: at 6 months to baseline
the change of EQ-5D over time (baseline - 3, 6 and 12 months) in a longitudinal view
Time frame: (baseline - 3, 6 and 12 months) in a longitudinal view
the change of SF-36 over time
Time frame: baseline - 3, 6 and 12 months
AF burden measured as percentage of time in AF during 7 day Holter ECG monitoring
Time frame: at 6 months
Incidence of AF recurrence
Time frame: at 3, 6 and 12 months
N-terminal-proBNP plasma levels
Time frame: at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 40513974Dilk P, Uhe T, Forkmann M, Eckardt L, Bode K, Seewoster T, Gaspar T, Neef M, Dinov B, Bacak M, Petroff D, Prettin C, Hindricks G, Laufs U, Dagres N, Wachter R. Pulmonary vein isolation versus SHAM-pulmonary vein isolation for symptomatic relief in patients with atrial fibrillation-Design and rationale of the PVI-SHAM-AF trial. Am Heart J. 2025 Dec;290:93-104. doi: 10.1016/j.ahj.2025.06.003. Epub 2025 Jun 11.
- Derived from this study: PubMed 42669307Wachter R, Haag P, Uhe T, Bacak M, Petroff D, Forkmann M, Eckardt L, Gaspar T, Dinov B, Neef M, Bode K, Seewoster T, Nedios S, Hilbert S, Lerche M, Lindemann F, Spies C, Beimel S, Paiva BTC, Hohendanner F, Tscholl V, Lenarczyk R, Bergau L, Sohns C, Prettin C, Laufs U, Hindricks G, Dagres N; PVI-SHAM-AF Investigators. Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial. Lancet. 2026 Aug 30:S0140-6736(26)01558-8. doi: 10.1016/S0140-6736(26)01558-8. Online ahead of print.
- Individual participant dataSharing planned: Yes
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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.
Rolf Wachter, Prof. Dr. study chair
University of Leipzig
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Vein Isolation in people with Atrial Fibrillation, run by University of Leipzig at 9 sites in 2 countries.
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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Poland. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
difference of AFEQT sum scores evaluated at 6 months (time frame: 6 months after randomisation compared to baseline). 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 NCT05119231, which also lists 2 linked publications.
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 28 Aug 2026.