Atrial Fibrillation and FlutterHIPAFNCT04855890
HIgh Power Short Duration Radiofrequency Ablation or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation
A study testing Ablation in people with Atrial Fibrillation and Flutter and Atrial Fibrillation, run by Universitätsklinikum Köln at 1 site in Germany.
Trial summary
Pulmonary vein isolation (PVI) using the cryoballoon has been proven equal to RF-PVI and is widely used. High Power Short Duration Ablation in RF-PVI has been successfully tested in several trials. Prospective data comparing both strategies is lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation and Flutter, Atrial Fibrillation, Paroxysmal Atrial Fibrillation
- What is being tested?
- Ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2021to 1 Aug 2023
- 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
- Symptomatic non-valvular atrial fibrillation with no prior ablation with an indication for re-ablation according to current guidelines.
- Age 18-85 years.
- Patient is able to provide informed consent and is willing to comply with the study protocol.
Who cannot join
- Contraindications for left atrial ablation
- History of interventional or surgical AF-ablation
- History of stroke during the past 12 months
- BMI >40kg/m2
- History of mitral valve surgery
- Severe mitral valve regurgitation
Show all 12Show fewer
- Inability to be treated with oral anticoagulation
- Presence of intracardiac thrombi
- Contraindication or absolute indication for one of the two strategies
- Pregnancy
- Participation in other clinical studies
- Unwilling to follow the study protocol and to attend follow-up visits
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of electrophysiology, Heart Center Cologne, University of Cologne
Cologne, North Rhine-Westphalia, 50937
Jonas Wörmann, MD, +4922147832396, jonas.woermann@uk-koeln.de
Arian Sultan, Priv.-Doz., +4922147832396, arian.sultan@uk-koeln.de
About this study
Official title: HIgh Power Short Duration Radiofrequency Ablation or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation - the HIPAF Trial
Pulmonary vein isolation (PVI) using the cryoballoon has been proven equal to RF-PVI and is widely used. High Power Short Duration Ablation in RF-PVI has been successfully tested in several trials. Prospective data comparing both strategies is lacking.
This trial will compare acute success rates, safety and foremost long-term outcome of two different PVI strategies (HPSD-PVI vs. cryo-PVI).
Read the detailed description
In several trials and real-life data pulmonary vein isolation (PVI) using the cryoballoon technique has been proven equal to RF-PVI for the treatment of paroxysmal atrial fibrillation (PAF). Due to the "single-shot character" of the device and shorter procedure times the cryoballoon is being widely used for PVI within the last years. However, additional endpoints such as "non-excitability" of the ablation line and consecutive arrhythmias may not be targeted properly by this device also lacking a detailed contact map to evaluate potential fibrotic areas.
For the past decade, the use of RF energy for successful PVI has been the "gold standard". However, ablation time and potential gaps within the circumferential ablation line are still an issue. High power (70 Watts) over short duration (7s) (HPSD) is a recently introduced RF-PVI concept. It has been shown to be as effective as conventional RF-PVI with equal safety features, shorter procedure durations and a superior long-term outcome. Therefore, HPSD-PVI in combination with the endpoint of "non-excitability" is potentially superior with regard to freedom of atrial arrhythmia during long-term FU compared to cryo-PVI with similar procedure times.
So far, randomized prospective data comparing HPSD versus cryo-PVI are lacking.
The aim of this prospective randomized study is to compare acute success rates, safety and foremost long-term outcome of two different PVI strategies (HPSD-PVI vs. cryo-PVI):
- To find the safest and most effective treatment strategy for PAF patients. 2. To evaluate the risk of complications for both treatment strategies.
- Evaluation of procedure endpoints like duration, costs and radiation dose.
The present study is a mono-center prospective randomized study enrolling 170 patients with PAF and no prior Ablation for AF.
Patients will be randomized to one of the following groups. Group A: Cryo-Ablation PVI will be performed using a Cryo-balloon. Group B: High-Power-Short-Duration PVI will be performed using HPSD RF-ablation. (70W over 5s posterior and 7s anterior) Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (EnSite, Abbott) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance Pro, Medtronic).
The study shall start enrolling patients in April 2021. The last patient shall be enrolled in January 2023. Since follow-up is 12 months, end of study is planned for January 2024.
- Being tested
- Ablation
- Keywords
- atrial fibrillation, high power short duration, pulmonary vein isolation, cryo-ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
The ablation procedure will be performed during deep sedation using midazolam, fentanyl and a continuous infusion of propofol. Vital parameters will be monitored. For catheter access three 8F sheaths will be inserted into the femoral veins. A multipolar diagnostic catheter will be placed in the coronary sinus. Single transseptal puncture and insertion of a 8.5 F transseptal sheath or 12F Cryo-Sheath (FlexCath AdvanceTM, Medtronic, Minneapolis, MN, USA) will be followed by PV angiographies. Before or shortly after transseptal puncture unfractionated heparin will be repeatedly administered to maintain an activated clotting time between 250 and 400s.
| Study group | Role | What they receive |
|---|---|---|
| Cryo-Ablation | Active comparator | Cryo-Balloon (Arctic Front Advance ProTM, Medtronic, Minneapolis, MN, USA) will be advanced to the LA and navigated to the PV's using an inner-lumen circular mapping catheter (Achieve AdvanceTM, Medtronic, Minneapolis, MN, USA). After confirming complete PV sealing by the CB using occlusion angiograms cryothermal energy will be applied for min 120 seconds aiming at PV isolation of all PV's according to the clinical standard. Receives: Procedure: Ablation |
| High Power Short Duration-Ablation | Active comparator | A detailed electroanatomical map of the left atrium during sinus rhythm will be acquired using Ensite (Abbott, St. Paul, MN, USA).
Upon completion of the LA map, a second transseptal puncture will be performed in order to insert an ablation catheter. To achieve antral PVI irrigated radiofrequency current ablation will be performed using a power of 70W and a flush rate of 8-30ml/min with a duration of 5 seconds for the anterior and 7 seconds for the posterior LA. Ablation catheters used will contain Flexibilty (Abbott, St. Paul, MN, USA) and TactiFlex (Abbott, St. Paul, MN, USA). Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial arrhythmia
Combined primary endpoint of recurrent atrial arrhythmia, onset of new AAD or re- ablation of atrial arrhythmia during the follow-up of 12 months after a 3-months blanking period.
Measured: 12 months after a 3 months blanking period
Secondary outcomes (4)
Periprocedural complications
Incidence of peri-procedural complications such as: major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombembolic events, death.
Measured: Within 48 hours of procedure
Number of re-hospitalisations
Number of re-hospitalisations (total and for cardiovascular reasons)
Measured: 12 months after a 3 months blanking period
Cardioversions
Number of electrical cardioversions
Measured: 12 months after a 3 months blanking period
Procedural data
Procedure duration, radiation dose, radiation duration
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 May 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation and FlutterStudies 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
- The present study is a mono-center prospective randomized study enrolling 170 patients with PAF and no prior Ablation for AF. Patients will be randomized to one of the following groups. Group A: Cryo-Ablation PVI will be performed using a Cryo-balloon. Group B: High-Power-Short-Duration PVI will be performed using HPSD RF-ablation. (70W over 5s posterior and 7s anterior) Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (EnSite, Abbott) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance Pro, Medtronic).
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arian Sultan, PD Dr., Principal investigator, University of Cologne, Heart Center, Dept. of ElectrophysiologyDaniel Steven, Prof. Dr., Principal investigator, University of Cologne, Heart Center, Dept. of Electrophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855890
- Sponsor's protocol ID
- HIPAF-21
- Acronym
- HIPAF
- Status last verified
- Jul 2021
- First submitted
- 20 Apr 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
PubMed 27567408Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
PubMed 27042964Murray MI, Arnold A, Younis M, Varghese S, Zeiher AM. Cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation: a meta-analysis of randomized controlled trials. Clin Res Cardiol. 2018 Aug;107(8):658-669. doi: 10.1007/s00392-018-1232-4. Epub 2018 Mar 21.
PubMed 29564527Kottmaier M, Popa M, Bourier F, Reents T, Cifuentes J, Semmler V, Telishevska M, Otgonbayar U, Koch-Buttner K, Lennerz C, Bartkowiak M, Kornmayer M, Rousseva E, Brkic A, Grebmer C, Kolb C, Hessling G, Deisenhofer I. Safety and outcome of very high-power short-duration ablation using 70 W for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. Europace. 2020 Mar 1;22(3):388-393. doi: 10.1093/europace/euz342.
PubMed 31872249
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIgh Power Short Duration Radiofrequency Ablation or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation - the HIPAF Trial
- ClinicalTrials.gov ID
- NCT04855890
- Acronym / sponsor ID
- HIPAF / HIPAF-21
- Keywords
- atrial fibrillation, high power short duration, pulmonary vein isolation, cryo-ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 22 Apr 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.
Pulmonary vein isolation (PVI) using the cryoballoon has been proven equal to RF-PVI and is widely used. High Power Short Duration Ablation in RF-PVI has been successfully tested in several trials. Prospective data comparing both strategies is lacking.
This trial will compare acute success rates, safety and foremost long-term outcome of two different PVI strategies (HPSD-PVI vs. cryo-PVI).
Detailed description
In several trials and real-life data pulmonary vein isolation (PVI) using the cryoballoon technique has been proven equal to RF-PVI for the treatment of paroxysmal atrial fibrillation (PAF). Due to the "single-shot character" of the device and shorter procedure times the cryoballoon is being widely used for PVI within the last years. However, additional endpoints such as "non-excitability" of the ablation line and consecutive arrhythmias may not be targeted properly by this device also lacking a detailed contact map to evaluate potential fibrotic areas.
For the past decade, the use of RF energy for successful PVI has been the "gold standard". However, ablation time and potential gaps within the circumferential ablation line are still an issue. High power (70 Watts) over short duration (7s) (HPSD) is a recently introduced RF-PVI concept. It has been shown to be as effective as conventional RF-PVI with equal safety features, shorter procedure durations and a superior long-term outcome. Therefore, HPSD-PVI in combination with the endpoint of "non-excitability" is potentially superior with regard to freedom of atrial arrhythmia during long-term FU compared to cryo-PVI with similar procedure times.
So far, randomized prospective data comparing HPSD versus cryo-PVI are lacking.
The aim of this prospective randomized study is to compare acute success rates, safety and foremost long-term outcome of two different PVI strategies (HPSD-PVI vs. cryo-PVI):
- To find the safest and most effective treatment strategy for PAF patients. 2. To evaluate the risk of complications for both treatment strategies.
- Evaluation of procedure endpoints like duration, costs and radiation dose.
The present study is a mono-center prospective randomized study enrolling 170 patients with PAF and no prior Ablation for AF.
Patients will be randomized to one of the following groups. Group A: Cryo-Ablation PVI will be performed using a Cryo-balloon. Group B: High-Power-Short-Duration PVI will be performed using HPSD RF-ablation. (70W over 5s posterior and 7s anterior) Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (EnSite, Abbott) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance Pro, Medtronic).
The study shall start enrolling patients in April 2021. The last patient shall be enrolled in January 2023. Since follow-up is 12 months, end of study is planned for January 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study is a mono-center prospective randomized study enrolling 170 patients with PAF and no prior Ablation for AF. Patients will be randomized to one of the following groups. Group A: Cryo-Ablation PVI will be performed using a Cryo-balloon. Group B: High-Power-Short-Duration PVI will be performed using HPSD RF-ablation. (70W over 5s posterior and 7s anterior) Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (EnSite, Abbott) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance Pro, Medtronic).
| Arm | Type | Receives |
|---|---|---|
| Cryo-Ablation | Active comparator | Procedure: AblationCryo-Balloon (Arctic Front Advance ProTM, Medtronic, Minneapolis, MN, USA) will be advanced to the LA and navigated to the PV's using an inner-lumen circular mapping catheter (Achieve AdvanceTM, Medtronic, Minneapolis, MN, USA). After confirming complete PV sealing by the CB using occlusion angiograms cryothermal energy will be applied for min 120 seconds aiming at PV isolation of all PV's according to the clinical standard. |
| High Power Short Duration-Ablation | Active comparator | Procedure: AblationA detailed electroanatomical map of the left atrium during sinus rhythm will be acquired using Ensite (Abbott, St. Paul, MN, USA). Upon completion of the LA map, a second transseptal puncture will be performed in order to insert an ablation catheter. To achieve antral PVI irrigated radiofrequency current ablation will be performed using a power of 70W and a flush rate of 8-30ml/min with a duration of 5 seconds for the anterior and 7 seconds for the posterior LA. Ablation catheters used will contain Flexibilty (Abbott, St. Paul, MN, USA) and TactiFlex (Abbott, St. Paul, MN, USA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic non-valvular atrial fibrillation with no prior ablation with an indication for re-ablation according to current guidelines.
- Age 18-85 years.
- Patient is able to provide informed consent and is willing to comply with the study protocol.
Key exclusion criteria (12 listed)
- Contraindications for left atrial ablation
- History of interventional or surgical AF-ablation
- History of stroke during the past 12 months
- BMI >40kg/m2
- History of mitral valve surgery
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 |
|---|---|---|
| AblationThe ablation procedure will be performed during deep sedation using midazolam, fentanyl and a continuous infusion of propofol. Vital parameters will be monitored. For catheter access three 8F sheaths will be inserted into the femoral veins. A multipolar diagnostic catheter will be placed in the coronary sinus. Single transseptal puncture and insertion of a 8.5 F transseptal sheath or 12F Cryo-Sheath (FlexCath AdvanceTM, Medtronic, Minneapolis, MN, USA) will be followed by PV angiographies. Before or shortly after transseptal puncture unfractionated heparin will be repeatedly administered to maintain an activated clotting time between 250 and 400s. | Procedure or surgery | Cryo-Ablation, High Power Short Duration-Ablation |
Primary outcome
Recurrence of atrial arrhythmia
Time frame: 12 months after a 3 months blanking period
Combined primary endpoint of recurrent atrial arrhythmia, onset of new AAD or re- ablation of atrial arrhythmia during the follow-up of 12 months after a 3-months blanking period.
4 secondary outcomes
Periprocedural complications
Time frame: Within 48 hours of procedure
Number of re-hospitalisations
Time frame: 12 months after a 3 months blanking period
Cardioversions
Time frame: 12 months after a 3 months blanking period
Procedural data
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Background: PubMed 27567408Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
- Background: PubMed 27042964Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
- Background: PubMed 29564527Murray MI, Arnold A, Younis M, Varghese S, Zeiher AM. Cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation: a meta-analysis of randomized controlled trials. Clin Res Cardiol. 2018 Aug;107(8):658-669. doi: 10.1007/s00392-018-1232-4. Epub 2018 Mar 21.
- Background: PubMed 31872249Kottmaier M, Popa M, Bourier F, Reents T, Cifuentes J, Semmler V, Telishevska M, Otgonbayar U, Koch-Buttner K, Lennerz C, Bartkowiak M, Kornmayer M, Rousseva E, Brkic A, Grebmer C, Kolb C, Hessling G, Deisenhofer I. Safety and outcome of very high-power short-duration ablation using 70 W for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. Europace. 2020 Mar 1;22(3):388-393. doi: 10.1093/europace/euz342.
- 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.
Arian Sultan, PD Dr. principal investigator
University of Cologne, Heart Center, Dept. of Electrophysiology
Daniel Steven, Prof. Dr. principal investigator
University of Cologne, Heart Center, Dept. of Electrophysiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Atrial Fibrillation and Flutter and Atrial Fibrillation, run by Universitätsklinikum Köln 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 3 inclusion and 12 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 26 Jul 2021. 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 Jonas Wörmann (+4917699992357, jonas.woermann@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial arrhythmia (time frame: 12 months after a 3 months blanking period). 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 NCT04855890, which also lists 4 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 26 Jul 2021.