Tachycardia; Paroxysmal, SupraventricularCOBRA-PATHNCT04078685
Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias
A study testing Standard catheter ablation and Contact Force-sensing-based catheter ablation in people with Tachycardia; Paroxysmal, Supraventricular and Tachycardia, Supraventricular, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The aim of this single-center prospective randomized controlled trial is to assess the superiority of contact-force-(CF)-sensing-based approach compared to conventional (non-CF-sensing) approach in the catheter ablation of PSVTs, and to investigate the safety of open-irrigated, contact-force-sensing ablation catheters… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia; Paroxysmal, Supraventricular, Tachycardia, Supraventricular
- What is being tested?
- Standard catheter ablation and Contact Force-sensing-based catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Jun 2018to 20 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral for electrophysiology study because of pre-excitation on 12-lead surface ECG and/or documented (or suspected) symptomatic PSVT
- Identification of AVNRT or WPW-AVRT (with manifest or concealed accessory pathway) during standard EP study
- Verbal consent to continue with ablation therapy
- Informed written consent to be included in the study
Who cannot join
- evidence of structural heart disease and/or myocardial ischemia
- pregnancy (and lack of exclusion of potential pregnancy)
- age below 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias: a Randomized Controlled Trial
The aim of this single-center prospective randomized controlled trial is to assess the superiority of contact-force-(CF)-sensing-based approach compared to conventional (non-CF-sensing) approach in the catheter ablation of PSVTs, and to investigate the safety of open-irrigated, contact-force-sensing ablation catheters (used in a "non-irrigated" mode) in these procedures.
Read the detailed description
Rationale:
Multiple studies have demonstrated the importance of adequate catheter-tissue contact in the creation of effective lesions during radiofrequency catheter ablation. The development of contact-force(CF)-sensing catheters have contributed significantly to improve clinical outcomes in atrial fibrillation 3-18. However CF-sensing technology is not used in the ablation of paroxysmal supraventricular tachycardia. Although PSVT ablation with the conventional approach (non-irrigated, non-CF-sensing catheters) is considered a relatively low-risk procedure with fairly high success rate (short-and long-term) 1,2,19, we hypothesize that contact-force sensing can further improve the outcomes of these procedures. Based on the results of studies on atrial fibrillation ablation (mentioned above) we believe that CF-sensing could similarly improve such important parameters as radiofrequency (RF) application number/time, total procedure time, and fluoroscopy time in cases of PSVT ablations, as well. In addition CF-sensing could also further improve acute success/recurrence rates of PSVT ablation, and might also be capable to further diminish complication risk.
Primary Objective:
The primary objective of the present study is to demonstrate the superiority of contact-force-sensing in the ablation of AVNRT and WPW-AVRT as assessed by the improvement in the number and duration of radiofrequency applications compared with the conventional ablation approach.
Secondary Objective:
Secondary objectives of the study are the followings:
- to demonstrate that contact-force-sensing catheters are superior in terms of total procedure duration and fluoroscopy times in the case of AVNRT/WPW-AVRT ablation.
- to show that the use of contact-force sensing catheters is non-inferior to conventional catheters (without contact-force-sensing) in terms of acute/long-term procedural success and procedural safety (major/minor complication rate) of AVNRT/WPW-AVRT ablations.
Study population:
All patients above 18 years without structural heart disease being referred for electrophysiological study and potential treatment with radiofrequency catheter ablation of atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular reentrant tachycardia (AVRT) with manifest (WPW syndrome) or concealed accessory pathways.
Intervention:
One group undergoes manual ablation using standard non-irrigated ablation catheters and the other group undergoes manual ablation with an open-irrigated ablation catheter equipped with CF- sensing (and utilized in a non-irrigated mode during ablation)
Main study parameters/endpoints:
The main study endpoint is the difference in RF application number during the procedures of AVNRT/WPW-AVRT ablation; secondary endpoints are differences in RF application rate, acute success rate, long-term recurrence rate (1 year) major/minor complication rate, and total procedure/fluoroscopy time.
- Being tested
- Standard catheter ablation, Contact Force-sensing-based catheter ablation
- Medical subject headings
- Tachycardia, Ventricular, Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard catheter ablationProcedure or surgery
Radiofrequency catheter ablation using a standard ablation catheters: not equipped with contact-force sensing
Contact Force-sensing-based catheter ablationProcedure or surgery
Radiofrequency catheter ablation using a Contact-Force-sensing ablation catheter
| Study group | Role | What they receive |
|---|---|---|
| CONVENTIONAL group | Active comparator | Patients with supraventricular tachycardia treated with radiofrequency ablation using a standard (non-contact-force sensing) ablation catheter Receives: Procedure: Standard catheter ablation |
| CONTACT-FORCE group | Experimental | Patients with supraventricular tachycardia treated with radiofrequency ablation using a Contact-Force-sensing ablation catheter Receives: Procedure: Contact Force-sensing-based catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of radiofrequency applications
The number of radiofrequency applications during the ablation procedures of AVNRT and WPW-AVRT
Measured: From the beginning till the end of the ablation procedure
Secondary outcomes (7)
Overall duration of radiofrequency applications
total of time spend from the beginning till the end of the ablation procedure
Measured: From the beginning till the end of the ablation procedure
Long-term procedural success
Free from recurrence of pre-excitation or the same clinical type of paroxysmal supraventricular tachycardia (AVNRT or AVRT)
Measured: At 12 months
Acute procedural success/failure
non-inducibility of clinical arrhythmia verified at the end of the standard EP study
Measured: at the end of the ablation procedure
Fluoroscopy time
total time for fluoroscopy time
Measured: From the beginning till the end of the ablation procedure
Total duration of procedure
total time for duration of the procedure
Measured: From the beginning till the end of the ablation procedure
(Serious) Adverse Events
all reported SAEs
Measured: Till 12 months
Time to recurrence of AVNRT/WPW-AVRT
if recurrence of AVNRT/WPW-AVRT, time to recurrence
Measured: up till 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start12 Jun 2018
- Primary completion9 Mar 2020
- Study completion20 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Tachycardia; Paroxysmal, SupraventricularStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamás Géczy, Erasmus Medical Center
- Investigators
- Tamas Szili-Torok, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078685
- Sponsor's protocol ID
- NL62017.078.17
- Acronym
- COBRA-PATH
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2019
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ullah W, Hunter RJ, Haldar S, McLean A, Dhinoja M, Sporton S, Earley MJ, Lorgat F, Wong T, Schilling RJ. Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: an international multicenter registry study. Pacing Clin Electrophysiol. 2014 Nov;37(11):1427-35. doi: 10.1111/pace.12501. Epub 2014 Sep 15.
PubMed 25220575Gerstenfeld EP. Contact force-sensing catheters: evolution or revolution in catheter ablation technology? Circ Arrhythm Electrophysiol. 2014 Feb;7(1):5-6. doi: 10.1161/CIRCEP.114.001424. No abstract available.
PubMed 24550405Shurrab M, Di Biase L, Briceno DF, Kaoutskaia A, Haj-Yahia S, Newman D, Lashevsky I, Nakagawa H, Crystal E. Impact of Contact Force Technology on Atrial Fibrillation Ablation: A Meta-Analysis. J Am Heart Assoc. 2015 Sep 21;4(9):e002476. doi: 10.1161/JAHA.115.002476.
PubMed 26391136Kautzner J, Neuzil P, Lambert H, Peichl P, Petru J, Cihak R, Skoda J, Wichterle D, Wissner E, Yulzari A, Kuck KH. EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace. 2015 Aug;17(8):1229-35. doi: 10.1093/europace/euv057. Epub 2015 Jun 3.
PubMed 26041872Kimura M, Sasaki S, Owada S, Horiuchi D, Sasaki K, Itoh T, Ishida Y, Kinjo T, Tomita H, Okumura K. Comparison of lesion formation between contact force-guided and non-guided circumferential pulmonary vein isolation: a prospective, randomized study. Heart Rhythm. 2014 Jun;11(6):984-91. doi: 10.1016/j.hrthm.2014.03.019. Epub 2014 Mar 18.
PubMed 24657428Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jais P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23. doi: 10.1016/j.hrthm.2011.08.021. Epub 2011 Aug 26.
PubMed 21872560Martinek M, Lemes C, Sigmund E, Derndorfer M, Aichinger J, Winter S, Nesser HJ, Purerfellner H. Clinical impact of an open-irrigated radiofrequency catheter with direct force measurement on atrial fibrillation ablation. Pacing Clin Electrophysiol. 2012 Nov;35(11):1312-8. doi: 10.1111/j.1540-8159.2012.03503.x. Epub 2012 Sep 4.
PubMed 22946636Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.
PubMed 25125294Ramdat Misier NL, Geczy T, Wijchers SA, Bhagwandien RE, Hoogendijk M, Mahmoodi BK, Szili-Torok T, Yap SC. Contact-force-sensing-based radiofrequency catheter ablation in paroxysmal supraventricular tachycardias: A randomized controlled trial. Heart Rhythm O2. 2026 Apr 15;7(7):1335-1343. doi: 10.1016/j.hroo.2026.04.007. eCollection 2026 Jul.
PubMed 42488158Geczy T, Ramdat Misier NL, Szili-Torok T. Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias (COBRA-PATH): a randomized controlled trial. Trials. 2020 Apr 9;21(1):321. doi: 10.1186/s13063-020-4219-1.
PubMed 32272969
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04078685
- Acronym / sponsor ID
- COBRA-PATH / NL62017.078.17
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 20 Mar 2021 (estimated)
- First posted
- 6 Sep 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.
The aim of this single-center prospective randomized controlled trial is to assess the superiority of contact-force-(CF)-sensing-based approach compared to conventional (non-CF-sensing) approach in the catheter ablation of PSVTs, and to investigate the safety of open-irrigated, contact-force-sensing ablation catheters (used in a "non-irrigated" mode) in these procedures.
Detailed description
Rationale:
Multiple studies have demonstrated the importance of adequate catheter-tissue contact in the creation of effective lesions during radiofrequency catheter ablation. The development of contact-force(CF)-sensing catheters have contributed significantly to improve clinical outcomes in atrial fibrillation 3-18. However CF-sensing technology is not used in the ablation of paroxysmal supraventricular tachycardia. Although PSVT ablation with the conventional approach (non-irrigated, non-CF-sensing catheters) is considered a relatively low-risk procedure with fairly high success rate (short-and long-term) 1,2,19, we hypothesize that contact-force sensing can further improve the outcomes of these procedures. Based on the results of studies on atrial fibrillation ablation (mentioned above) we believe that CF-sensing could similarly improve such important parameters as radiofrequency (RF) application number/time, total procedure time, and fluoroscopy time in cases of PSVT ablations, as well. In addition CF-sensing could also further improve acute success/recurrence rates of PSVT ablation, and might also be capable to further diminish complication risk.
Primary Objective:
The primary objective of the present study is to demonstrate the superiority of contact-force-sensing in the ablation of AVNRT and WPW-AVRT as assessed by the improvement in the number and duration of radiofrequency applications compared with the conventional ablation approach.
Secondary Objective:
Secondary objectives of the study are the followings:
- to demonstrate that contact-force-sensing catheters are superior in terms of total procedure duration and fluoroscopy times in the case of AVNRT/WPW-AVRT ablation.
- to show that the use of contact-force sensing catheters is non-inferior to conventional catheters (without contact-force-sensing) in terms of acute/long-term procedural success and procedural safety (major/minor complication rate) of AVNRT/WPW-AVRT ablations.
Study population:
All patients above 18 years without structural heart disease being referred for electrophysiological study and potential treatment with radiofrequency catheter ablation of atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular reentrant tachycardia (AVRT) with manifest (WPW syndrome) or concealed accessory pathways.
Intervention:
One group undergoes manual ablation using standard non-irrigated ablation catheters and the other group undergoes manual ablation with an open-irrigated ablation catheter equipped with CF- sensing (and utilized in a non-irrigated mode during ablation)
Main study parameters/endpoints:
The main study endpoint is the difference in RF application number during the procedures of AVNRT/WPW-AVRT ablation; secondary endpoints are differences in RF application rate, acute success rate, long-term recurrence rate (1 year) major/minor complication rate, and total procedure/fluoroscopy time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONVENTIONAL group | Active comparator | Procedure: Standard catheter ablationPatients with supraventricular tachycardia treated with radiofrequency ablation using a standard (non-contact-force sensing) ablation catheter |
| CONTACT-FORCE group | Experimental | Procedure: Contact Force-sensing-based catheter ablationPatients with supraventricular tachycardia treated with radiofrequency ablation using a Contact-Force-sensing ablation catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Referral for electrophysiology study because of pre-excitation on 12-lead surface ECG and/or documented (or suspected) symptomatic PSVT
- Identification of AVNRT or WPW-AVRT (with manifest or concealed accessory pathway) during standard EP study
- Verbal consent to continue with ablation therapy
- Informed written consent to be included in the study
Key exclusion criteria (3 listed)
- evidence of structural heart disease and/or myocardial ischemia
- pregnancy (and lack of exclusion of potential pregnancy)
- age below 18 years
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 |
|---|---|---|
| Standard catheter ablationRadiofrequency catheter ablation using a standard ablation catheters: not equipped with contact-force sensing | Procedure or surgery | CONVENTIONAL group |
| Contact Force-sensing-based catheter ablationRadiofrequency catheter ablation using a Contact-Force-sensing ablation catheter | Procedure or surgery | CONTACT-FORCE group |
Primary outcome
Number of radiofrequency applications
Time frame: From the beginning till the end of the ablation procedure
The number of radiofrequency applications during the ablation procedures of AVNRT and WPW-AVRT
7 secondary outcomes
Overall duration of radiofrequency applications
Time frame: From the beginning till the end of the ablation procedure
Long-term procedural success
Time frame: At 12 months
Acute procedural success/failure
Time frame: at the end of the ablation procedure
Fluoroscopy time
Time frame: From the beginning till the end of the ablation procedure
Total duration of procedure
Time frame: From the beginning till the end of the ablation procedure
(Serious) Adverse Events
Time frame: Till 12 months
Time to recurrence of AVNRT/WPW-AVRT
Time frame: up till 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Background: PubMed 25220575Ullah W, Hunter RJ, Haldar S, McLean A, Dhinoja M, Sporton S, Earley MJ, Lorgat F, Wong T, Schilling RJ. Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: an international multicenter registry study. Pacing Clin Electrophysiol. 2014 Nov;37(11):1427-35. doi: 10.1111/pace.12501. Epub 2014 Sep 15.
- Background: PubMed 24550405Gerstenfeld EP. Contact force-sensing catheters: evolution or revolution in catheter ablation technology? Circ Arrhythm Electrophysiol. 2014 Feb;7(1):5-6. doi: 10.1161/CIRCEP.114.001424. No abstract available.
- Background: PubMed 26391136Shurrab M, Di Biase L, Briceno DF, Kaoutskaia A, Haj-Yahia S, Newman D, Lashevsky I, Nakagawa H, Crystal E. Impact of Contact Force Technology on Atrial Fibrillation Ablation: A Meta-Analysis. J Am Heart Assoc. 2015 Sep 21;4(9):e002476. doi: 10.1161/JAHA.115.002476.
- Background: PubMed 26041872Kautzner J, Neuzil P, Lambert H, Peichl P, Petru J, Cihak R, Skoda J, Wichterle D, Wissner E, Yulzari A, Kuck KH. EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace. 2015 Aug;17(8):1229-35. doi: 10.1093/europace/euv057. Epub 2015 Jun 3.
- Background: PubMed 24657428Kimura M, Sasaki S, Owada S, Horiuchi D, Sasaki K, Itoh T, Ishida Y, Kinjo T, Tomita H, Okumura K. Comparison of lesion formation between contact force-guided and non-guided circumferential pulmonary vein isolation: a prospective, randomized study. Heart Rhythm. 2014 Jun;11(6):984-91. doi: 10.1016/j.hrthm.2014.03.019. Epub 2014 Mar 18.
- Background: PubMed 21872560Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jais P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23. doi: 10.1016/j.hrthm.2011.08.021. Epub 2011 Aug 26.
- Background: PubMed 22946636Martinek M, Lemes C, Sigmund E, Derndorfer M, Aichinger J, Winter S, Nesser HJ, Purerfellner H. Clinical impact of an open-irrigated radiofrequency catheter with direct force measurement on atrial fibrillation ablation. Pacing Clin Electrophysiol. 2012 Nov;35(11):1312-8. doi: 10.1111/j.1540-8159.2012.03503.x. Epub 2012 Sep 4.
- Background: PubMed 25125294Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.
- Derived from this study: PubMed 42488158Ramdat Misier NL, Geczy T, Wijchers SA, Bhagwandien RE, Hoogendijk M, Mahmoodi BK, Szili-Torok T, Yap SC. Contact-force-sensing-based radiofrequency catheter ablation in paroxysmal supraventricular tachycardias: A randomized controlled trial. Heart Rhythm O2. 2026 Apr 15;7(7):1335-1343. doi: 10.1016/j.hroo.2026.04.007. eCollection 2026 Jul.
- Derived from this study: PubMed 32272969Geczy T, Ramdat Misier NL, Szili-Torok T. Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias (COBRA-PATH): a randomized controlled trial. Trials. 2020 Apr 9;21(1):321. doi: 10.1186/s13063-020-4219-1.
- 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.
Tamas Szili-Torok, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard catheter ablation and Contact Force-sensing-based catheter ablation in people with Tachycardia; Paroxysmal, Supraventricular and Tachycardia, Supraventricular, run by Erasmus Medical Center at 1 site in Netherlands.
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 3 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 3 Sep 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 Netherlands. 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?
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?
Number of radiofrequency applications (time frame: From the beginning till the end of the ablation procedure). 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 NCT04078685, which also lists 10 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 3 Sep 2020.