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Atrial Fibrillation (AF)DELTA-MAP AFNCT07899918

Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation

A study testing Marshall Plan-Based Ablation Strategy, PV re-isolation only and Additional Left Atrial Ablation in people with Atrial Fibrillation (AF), run by Karolinska University Hospital at 1 site in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This clinical trial will assess the efficacy and safety of a Marshall plan-based ablation strategy without ethanol infusion into the vein of Marshall in patients with persistent atrial fibrillation undergoing repeat ablation with a dual-energy lattice-tip catheter. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
Marshall Plan-Based Ablation Strategy, PV re-isolation only and Additional Left Atrial Ablation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
1 siteSweden
Study dates
Jan 2027to Mar 2030
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

  • Clinical indication for re-ablation of persistent atrial fibrillation
  • Previous catheter ablation for atrial fibrillation with PVI
  • Suitable candidate for catheter ablation according to European Society of Cardiology (ESC) guidelines
  • Age ≥18 years.

Who cannot join

  • Previous linear ablations in the left atrium beyond the PVI
  • Acute coronary syndrome or coronary artery bypass surgery within 12 weeks.
  • Severe valvular heart disease using the ESC guidelines or congenital heart disease.
  • Contraindication to oral anticoagulation.
  • AF due to a reversible cause.
  • Medical conditions likely to limit survival<12 months
  • Patients who are unable or unwilling to provide informed consent.
  • BMI<18 kg/m2 or BMI>37 kg/m2

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Serkan Saygi, MD contact

+46 8 585 800 00

serkan.saygi@ki.se

Emmanouil Charitakis, Phd contact

+46 8 585 800 00

emmanouil.charitakis@regionstockholm.se

Sweden1 site

  • Karolinska University Hospital

    Stockholm, 14286

    Serkan Saygi, Phd, +46858580000, serkan.saygi@ki.se

    Emmanouil Charitakis, Phd, +46858580000, emmanouil.charitakis@regionstockholm.se

Other trials in Sweden

About this study

Official title: Dual-Energy Lattice-Tip Assisted "MArshall-Plan" Strategy Versus Pulmonary Vein Re-Isolation Alone in Redo Persistent Atrial Fibrillation: A Randomized Trial

This clinical trial will assess the efficacy and safety of a Marshall plan-based ablation strategy without ethanol infusion into the vein of Marshall in patients with persistent atrial fibrillation undergoing repeat ablation with a dual-energy lattice-tip catheter. Eligible participants will be randomized to receive either pulmonary vein re-isolation alone or pulmonary vein re-isolation plus the Marshall plan-based strategy. Patients who are found to have all pulmonary veins already isolated at the time of the procedure, or who are not suitable candidates for the Marshall plan-based approach, will be included in a separate observational cohort.

Read the detailed description

Pulmonary vein (PV) re-isolation remains the standard ablation strategy for patients with persistent atrial fibrillation undergoing repeat ablation procedures. However, recurrence after PV re-isolation remains common, and the optimal adjunctive ablation strategy during redo procedures has not been established. The introduction of dual-energy lattice-tip catheters enables the creation of durable linear lesions beyond PV isolation while avoiding the need for ethanol infusion into the vein of Marshall. Although the Marshall-plan strategy has demonstrated favorable results in patients undergoing first-time ablation, randomized data evaluating this approach during repeat ablation procedures are lacking.

This study aims to evaluate the efficacy and safety of a Marshall plan-based ablation strategy without ethanol infusion into the vein of Marshall, in addition to pulmonary vein re-isolation, compared with pulmonary vein re-isolation alone in patients with persistent atrial fibrillation undergoing repeat ablation using a dual-energy lattice-tip catheter. Eligible participants will be randomized to one of the two treatment strategies. Patients whose pulmonary veins are found to be already isolated at the time of the procedure, or for whom the Marshall plan-based approach is not feasible, will be included in a separate observational cohort.

Being tested
Marshall Plan-Based Ablation Strategy, PV re-isolation only, Additional Left Atrial 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.

  • Marshall Plan-Based Ablation StrategyProcedure or surgery

    Pulmonary vein re-isolation plus posterior mitral isthmus, roof, and cavotricuspid isthmus linear ablation using a dual-energy lattice-tip catheter without ethanol infusion into the vein of Marshall.

  • PV re-isolation onlyProcedure or surgery

    Pulmonary vein re-isolation only using a dual-energy lattice-tip catheter.

  • Additional Left Atrial AblationProcedure or surgery

    Additional left atrial ablation performed according to the scar distribution

Study groups in NCT07899918
Study groupRoleWhat they receive
PV re-isolation plus Marshall plan-based ablationExperimentalParticipants will undergo pulmonary vein re-isolation combined with a Marshall plan-based ablation strategy using a dual-energy lattice-tip catheter.
Receives: Procedure: Marshall Plan-Based Ablation Strategy
PV re-isolation onlyActive comparatorParticipants will undergo pulmonary vein re-isolation using a dual-energy lattice-tip catheter.
Receives: Procedure: PV re-isolation only
Observational armOtherPatients with already isolated pulmonary veins or those unsuitable for a Marshall plan-based strategy will be included in this observational cohort and will not undergo randomization.
Receives: Procedure: Additional Left Atrial Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Between-group difference in atrial-arrhythmia burden

    Between-group difference in atrial-arrhythmia burden, defined as the percentage of analyzable ILR time spent in atrial arrhythmia, measured during off-AAD intervals from the end of the 8-week blanking period through 12 months and before any crossover ablation, comparing PV re-isolation plus Marshall-plan strategy versus PV re-isolation alone.

    Measured: From the end of the 8-week blanking period through 12 months and before any crossover ablation

Secondary outcomes (19)

  1. Number of Participants with Freedom from Atrial Arrhythmia after 1 Ablation Procedure without Antiarrhythmic Drugs (AAD)

    1. Freedom from AF/AT/AFL ≥30 s at 12 months (after 8-week blanking period), centrally adjudicated

    Measured: From the end of the 8-week blanking period through 12 months and before any crossover ablation

  2. Arrhythmia burden during off-AAD follow-up time and before any crossover ablation

    Arrhythmia burden during off-AAD follow-up time and before any crossover ablation, with additional sensitivity analyses accounting for DC cardioversion and repeat ablation.

    Measured: From the end of the 8-week blanking period through 12 months and before any crossover ablation

  3. Arrhythmia burden between groups in patients on AAD

    Measured: From the end of the 8-week blanking period through 12 months and before any crossover ablation

  4. Between-group difference in atrial-arrhythmia burden, percent of analyzable time in AF/AT/AFL by ILR measured irrespective of the AAD use

    Measured: From the end of the blanking period (week 8) through 12 months, comparing PV re-isolation + Marshall-plan vs PV re-isolation only.

  5. Differences in arrhythmia burden without blanking period.

    Measured: Through 12 months, comparing PV re-isolation + Marshall-plan vs PV re-isolation only.

  6. Total procedure time

    Measured: During the index procedure

  7. Total fluoroscopy time

    Measured: During the index procedure

  8. Freedom from DC cardioverted atrial arrhythmia

    Measured: At 6 and 12 months

  9. Freedom from atrial fibrillation

    Measured: At 6 and 12 months

  10. Number of DC-cardioverted atrial arrhythmia

    Measured: From the end of the blanking period (week 8) through 12 months, comparing PV re-isolation + Marshall-plan vs PV re-isolation only.

  11. Burden analysis adjusted for the number of post-blanking DC cardioversions

    Measured: From the end of the blanking period (week 8) through 12 months, comparing PV re-isolation + Marshall-plan vs PV re-isolation only.

  12. Sensitivity analysis excluding ILR time after any repeat ablation.

    Measured: Up to 12 months after the index procedure

  13. Freedom from any repeat ablation procedure

    Measured: Through 12 months

  14. Composite adverse events

    Measured: From the index procedure through 12 months of follow-up

  15. The primary safety endpoint would be any adverse event related to ablation

    Measured: From the index procedure through 12 months of follow-up

  16. Differences in AF and atrial tachycardia burden between the two randomization groups (ILR) and possible predictors of this difference

    Measured: From the index procedure through 12 months of follow-up

  17. LA size, morphology, and function from echocardiographic and CT imaging data

    Measured: At the index procedure

  18. HRQoL measured with ASTA

    Measured: 12 months after ablation

  19. Correlation between arrhythmia burden and HRQoL/symptoms

    Measured: At 12 months after ablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionFeb 2029 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

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
Randomization 1:1
Masking
Single blind
Who is masked
Participant
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07899918
Sponsor's protocol ID
2026-02286-01
Acronym
DELTA-MAP AF
Status last verified
Oct 2026
First submitted
20 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anter E, Mansour M, Nair DG, Sharma D, Taigen TL, Neuzil P, Kiehl EL, Kautzner J, Osorio J, Mountantonakis S, Natale A, Hummel JD, Amin AK, Siddiqui UR, Harlev D, Hultz P, Liu S, Onal B, Tarakji KG, Reddy VY; SPHERE PER-AF Investigators. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med. 2024 Aug;30(8):2303-2310. doi: 10.1038/s41591-024-03022-6. Epub 2024 May 17.

    PubMed 38760584

  • Cochet H, Nakatani Y, Sridi-Cheniti S, Cheniti G, Ramirez FD, Nakashima T, Eggert C, Schneider C, Viswanathan R, Derval N, Duchateau J, Pambrun T, Chauvel R, Reddy VY, Montaudon M, Laurent F, Sacher F, Hocini M, Haissaguerre M, Jais P. Pulsed field ablation selectively spares the oesophagus during pulmonary vein isolation for atrial fibrillation. Europace. 2021 Sep 8;23(9):1391-1399. doi: 10.1093/europace/euab090.

    PubMed 33961027

  • Derval N, Tixier R, Duchateau J, Bouteiller X, Loock T, Denis A, Chauvel R, Bouyer B, Arnaud M, Yokoyama M, Kowalewski C, Monaco C, Ascione C, Sacher F, Hocini M, Jais P, Haissaguerre M, Pambrun T. Marshall-Plan Ablation Strategy Versus Pulmonary Vein Isolation in Persistent AF: A Randomized Controlled Trial. Circ Arrhythm Electrophysiol. 2025 May;18(5):e013427. doi: 10.1161/CIRCEP.124.013427. Epub 2025 May 20.

    PubMed 40392905

  • Sang C, Liu Q, Lai Y, Xia S, Jiang R, Li S, Guo Q, Li Q, Gao M, Guo X, Huang L, Liu N, Jiang C, Zuo S, Liu X, Li M, Ge W, Song S, Chen L, Xie S, Zou J, Chen K, Liu X, Hu H, Wang X, Zhang J, Wang Z, Wang C, He L, Jiang C, Tang R, Zhou N, Wang Y, Long D, Du X, Jiang C, Macle L, Dong J, Ma C; PROMPT-AF investigators. Pulmonary Vein Isolation With Optimized Linear Ablation vs Pulmonary Vein Isolation Alone for Persistent AF: The PROMPT-AF Randomized Clinical Trial. JAMA. 2025 Feb 4;333(5):381-389. doi: 10.1001/jama.2024.24438.

    PubMed 39556379

  • Derval N, Duchateau J, Denis A, Ramirez FD, Mahida S, Andre C, Krisai P, Nakatani Y, Kitamura T, Takigawa M, Chauvel R, Tixier R, Pillois X, Sacher F, Hocini M, Haissaguerre M, Jais P, Pambrun T. Marshall bundle elimination, Pulmonary vein isolation, and Line completion for ANatomical ablation of persistent atrial fibrillation (Marshall-PLAN): Prospective, single-center study. Heart Rhythm. 2021 Apr;18(4):529-537. doi: 10.1016/j.hrthm.2020.12.023. Epub 2020 Dec 29.

    PubMed 33383226

  • Valderrabano M, Peterson LE, Swarup V, Schurmann PA, Makkar A, Doshi RN, DeLurgio D, Athill CA, Ellenbogen KA, Natale A, Koneru J, Dave AS, Giorgberidze I, Afshar H, Guthrie ML, Bunge R, Morillo CA, Kleiman NS. Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation: The VENUS Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1620-1628. doi: 10.1001/jama.2020.16195.

    PubMed 33107945

  • Inoue K, Hikoso S, Masuda M, Furukawa Y, Hirata A, Egami Y, Watanabe T, Minamiguchi H, Miyoshi M, Tanaka N, Oka T, Okada M, Kanda T, Matsuda Y, Kawasaki M, Hayashi K, Kitamura T, Dohi T, Sunaga A, Mizuno H, Nakatani D, Sakata Y; OCVC Arrhythmia Investigators. Pulmonary vein isolation alone vs. more extensive ablation with defragmentation and linear ablation of persistent atrial fibrillation: the EARNEST-PVI trial. Europace. 2021 Apr 6;23(4):565-574. doi: 10.1093/europace/euaa293.

    PubMed 33200213

  • Kistler PM, Chieng D, Sugumar H, Ling LH, Segan L, Azzopardi S, Al-Kaisey A, Parameswaran R, Anderson RD, Hawson J, Prabhu S, Voskoboinik A, Wong G, Morton JB, Pathik B, McLellan AJ, Lee G, Wong M, Finch S, Pathak RK, Raja DC, Sterns L, Ginks M, Reid CM, Sanders P, Kalman JM. Effect of Catheter Ablation Using Pulmonary Vein Isolation With vs Without Posterior Left Atrial Wall Isolation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The CAPLA Randomized Clinical Trial. JAMA. 2023 Jan 10;329(2):127-135. doi: 10.1001/jama.2022.23722.

    PubMed 36625809

  • Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

    PubMed 25946280

  • Marrouche NF, Wazni O, McGann C, Greene T, Dean JM, Dagher L, Kholmovski E, Mansour M, Marchlinski F, Wilber D, Hindricks G, Mahnkopf C, Wells D, Jais P, Sanders P, Brachmann J, Bax JJ, Morrison-de Boer L, Deneke T, Calkins H, Sohns C, Akoum N; DECAAF II Investigators. Effect of MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The DECAAF II Randomized Clinical Trial. JAMA. 2022 Jun 21;327(23):2296-2305. doi: 10.1001/jama.2022.8831.

    PubMed 35727277

  • Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

    PubMed 32860505

Questions about this trial

What is this clinical trial studying?

A study testing Marshall Plan-Based Ablation Strategy, PV re-isolation only and Additional Left Atrial Ablation in people with Atrial Fibrillation (AF), run by Karolinska University Hospital at 1 site in Sweden.

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 8 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: opening soon, as of the sponsor's last update on 28 Oct 2026. 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 Sweden. 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?

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?

Contact Serkan Saygi, MD (+46 8 585 800 00, serkan.saygi@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between-group difference in atrial-arrhythmia burden (time frame: From the end of the 8-week blanking period through 12 months and before any crossover ablation). 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 NCT07899918, which also lists 11 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 Oct 2026.

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