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MARSHALL PLAN Vs. Pulmonary Veins Isolation Monocentric Trial (PLAN-MARSHALL)

Primary Purpose

Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Destruction of Marshall bundles
Pulmonary veins isolation
Linear ablation in the left and right atria
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Persistent atrial fibrillation, Pulmonary vein isolation, Catheter ablation, Ethanolisation, Ligament of Marshall

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years of both genders

  • Suitable candidate for catheter non-emergent mapping and ablation of atrial fibrillation defined as:

    • History of symptomatic persistent atrial fibrillation in the past year documented by ECG AND
    • Treatment failure by at least one class of anti-arrhythmic medications (I-IV) (intolerance or recurrence of symptomatic AF)
  • Patient affiliated or beneficiary of social security scheme
  • Free, informed and written consent signed by the participant and the principal investigator (at least at the inclusion date and before all exams required for the clinical research)
  • Effective contraception for women of childbearing potential

Exclusion Criteria:

  • Minor
  • Prior left atrial heart ablation procedure
  • Documented left atrial thrombus or another abnormality which precludes catheter introduction
  • Contraindication to anticoagulation therapy (heparin, warfarin, or Novel Oral Anticoagulant (NOAC)
  • Contraindication to iodinated contrast product XENETIX® (iobitridol hypersensitivity or at one of these excipients, history of major immediate reaction or cutaneous reaction to XENETIX® infusion, thyrotoxicosis)
  • Hypersensitivity to ethanol
  • Unstable angina or ongoing myocardial ischemia
  • Myocardial infarction within 3 months prior to inclusion
  • Congenital heart disease, where the underlying abnormality increases the ablation risk
  • Pulmonary hypertension (pulmonary arterial hypertension > 50 mmHg)
  • Severe uncontrolled systemic hypertension with systolic blood pressure (SBP) > 200 mm Hg within 30 days prior to inclusion
  • Severe bleeding, clotting or thrombotic disorder
  • Left atrial diameter > 60 mm (parasternal view)
  • Hypertrophic cardiomyopathy defined by a left ventricular septum thickness > 1.5 cm
  • Pregnant, parturient or nursing women
  • Unable or unwilling to provide written informed consent
  • Patient detained by judicial or administrative order
  • Patient under psychiatric care
  • Patient admitted in a social or healthcare establishment for any purpose other than the research
  • Subject to a legal protection order (guardianship, patient under legal protection)

Sites / Locations

  • Bordeaux University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Marshall Plan arm

Pulmonary vein isolation arm

Arm Description

Patients will undergo (1) the destruction of Marshall bundles by ethanol infusion followed by ablation of the distal coronary sinus bundles, the ridge and the saddle; (2) the standard pulmonary veins sleeves isolation; (3) and finally the ablation of the mitral, the roof, and the cavo-tricuspid isthmus.

Outcomes

Primary Outcome Measures

Recurrence of AF or AT greater than 30 seconds with or without antiarrhythmic medications.
Recurrence rate (percentage) of AF or AT > 30 seconds after the blanking period of 3-months post ablation, at 12 months with or without antiarrhythmic medications. Recurrences will be identified through transtelephonic ECG monitor with weekly transmitted ECG and at any time in case of symptoms.

Secondary Outcome Measures

Recurrence of AF greater than 30 seconds
Recurrence rate (percentage) of AF greater than 30 seconds after the blanking period of 3-months post procedure at 12 months. It will be identified through transtelephonic ECG monitor with weekly transmitted ECG and at any time in case of symptoms.
Recurrence of AF or AT greater than 30 seconds without antiarrhythmic medications
Recurrence rate (percentage) of AF or AT > 30 seconds after the blanking period of 3-months post ablation, at 12 months without antiarrhythmic medications. Recurrences will be identified through transtelephonic ECG monitor with weekly transmitted ECG and at any time in case of symptoms.
Rate of patients under antiarrhythmic medications
Percentage of patients
Number of patients with repeat procedures
Number of patients
Rate of periprocedural complications
Percentage of transient ischemic attack or stroke, cardiac tamponade, atrio-oesophageal fistula, pericarditis, complications at access site (hematoma, arteriovenous fistula, pseudoaneurysm).
AF discontinuation rate during procedure
Percentage of AF discontinuation
Per-procedure AF / AT inducibility rate
Percentage of per-procedure AF / AT inducibility
Mitral line block rate
Percentage of mitral line block according to consensus block criteria
Radiofrequency duration necessary for pulmonary veins isolation
Duration measured in seconds

Full Information

First Posted
December 18, 2019
Last Updated
December 14, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04206982
Brief Title
MARSHALL PLAN Vs. Pulmonary Veins Isolation Monocentric Trial
Acronym
PLAN-MARSHALL
Official Title
MARSHALL Bundles Elimination, Pulmonary Veins Isolation and Lines Completion for ANatomical Ablation of Persistent Atrial Fibrillation Versus Pulmonary Veins Isolation: The MARSHALL PLAN Monocentric Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In ablation strategy for persistent Atrial Fibrillation (PsAF), ablation limited to Pulmonary Vein (PV) isolation is the most straightforward approach but the result give only 50% of arrhythmia free follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been incorporated in current ablation strategies. The investigators sought to investigate a new ablation strategy that target systematically the vein of Marshall by ethanol infusion. This step is integrated in a new ablation strategy consisting in a global anatomical substrate based ablation including PV isolation and left atrial linear ablation (Marshall-Plan). The main objective of this study is to compare the 12 month freedom from any arrhythmia (Atrial Fibrillation (AF)/Atrial Tachycardia (AT)) between the Marshall-Plan approach and the PV isolation approach.
Detailed Description
Ablation strategy for persistent AF besides pulmonary vein isolation remains controversial. Indeed, two approaches have prevailed over the past two decades "cox-maze" strategy and mapping of the left atrium but both methods have failed to decrease AF recurrences (as shown by the clinical trial STAR AF 2). Two studies have demonstrated that the ligament of Marshall (LOM) could be the source of focal activities, the substrate of reentries and a strong parasympathetic modulator. For these reasons, LOM may represent a major target in AF treatment besides PV isolation. Nevertheless, conventional ablation techniques do not ensure the complete destruction of Marshall's musculature and parasympathetic ganglia that surround it, largely isolated by a sheath of adipose tissue. To overcome this technical limitation, LOM elimination can be achieved by alcohol injection into the vein of Marshall.The investigator innovative approach called Marshall Plan will then consists in 3 steps: 1) the destruction of Marshall bundles by ethanol infusion followed by the ablation of the distal Coronary Sinus (CS) bundles, the ridge and the saddle; 2) the standard PV isolation; 3) and finally ablation of the mitral line, the roof and of the cavo-tricuspid isthmus, main causes of recurrence in atrial flutter. Before ablation procedure patients will be randomized in 2 arms: Marshall Plan (treatment arm) or pulmonary vein isolation (control arm). Patients will be followed at 3, 6, 9 and 12 months in-office visits or hospitalization. Patients will have different tests: electrocardiogram (ECG), cardiac echography, stress test, 24hours Holter and transtelephonic ECG monitor with weekly transmitted ECG and at any time in case of symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Persistent atrial fibrillation, Pulmonary vein isolation, Catheter ablation, Ethanolisation, Ligament of Marshall

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The Marshall Plan is a prospective randomized, parallel-group, monocentric clinical trial of superiority.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Marshall Plan arm
Arm Type
Experimental
Arm Description
Patients will undergo (1) the destruction of Marshall bundles by ethanol infusion followed by ablation of the distal coronary sinus bundles, the ridge and the saddle; (2) the standard pulmonary veins sleeves isolation; (3) and finally the ablation of the mitral, the roof, and the cavo-tricuspid isthmus.
Arm Title
Pulmonary vein isolation arm
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Destruction of Marshall bundles
Intervention Description
Destruction of Marshall bundles by ethanol 96% infusion (2 separate injections of 5ml on 1 minute each) followed by ablation of the distal coronary sinus bundles, the ridge and the saddle.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary veins isolation
Intervention Description
Achievement of a wide disconnection of the right and left pulmonary veins.
Intervention Type
Procedure
Intervention Name(s)
Linear ablation in the left and right atria
Intervention Description
Ablation of the mitral, the roof, and the cavo-tricuspid isthmus.
Primary Outcome Measure Information:
Title
Recurrence of AF or AT greater than 30 seconds with or without antiarrhythmic medications.
Description
Recurrence rate (percentage) of AF or AT > 30 seconds after the blanking period of 3-months post ablation, at 12 months with or without antiarrhythmic medications. Recurrences will be identified through transtelephonic ECG monitor with weekly transmitted ECG and at any time in case of symptoms.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Recurrence of AF greater than 30 seconds
Description
Recurrence rate (percentage) of AF greater than 30 seconds after the blanking period of 3-months post procedure at 12 months. It will be identified through transtelephonic ECG monitor with weekly transmitted ECG and at any time in case of symptoms.
Time Frame
12 months
Title
Recurrence of AF or AT greater than 30 seconds without antiarrhythmic medications
Description
Recurrence rate (percentage) of AF or AT > 30 seconds after the blanking period of 3-months post ablation, at 12 months without antiarrhythmic medications. Recurrences will be identified through transtelephonic ECG monitor with weekly transmitted ECG and at any time in case of symptoms.
Time Frame
12 months
Title
Rate of patients under antiarrhythmic medications
Description
Percentage of patients
Time Frame
12 months
Title
Number of patients with repeat procedures
Description
Number of patients
Time Frame
12 months
Title
Rate of periprocedural complications
Description
Percentage of transient ischemic attack or stroke, cardiac tamponade, atrio-oesophageal fistula, pericarditis, complications at access site (hematoma, arteriovenous fistula, pseudoaneurysm).
Time Frame
12 months
Title
AF discontinuation rate during procedure
Description
Percentage of AF discontinuation
Time Frame
12 months
Title
Per-procedure AF / AT inducibility rate
Description
Percentage of per-procedure AF / AT inducibility
Time Frame
12 months
Title
Mitral line block rate
Description
Percentage of mitral line block according to consensus block criteria
Time Frame
12 months
Title
Radiofrequency duration necessary for pulmonary veins isolation
Description
Duration measured in seconds
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years of both genders Suitable candidate for catheter non-emergent mapping and ablation of atrial fibrillation defined as: History of symptomatic persistent atrial fibrillation in the past year documented by ECG AND Treatment failure by at least one class of anti-arrhythmic medications (I-IV) (intolerance or recurrence of symptomatic AF) Patient affiliated or beneficiary of social security scheme Free, informed and written consent signed by the participant and the principal investigator (at least at the inclusion date and before all exams required for the clinical research) Effective contraception for women of childbearing potential Exclusion Criteria: Minor Prior left atrial heart ablation procedure Documented left atrial thrombus or another abnormality which precludes catheter introduction Contraindication to anticoagulation therapy (heparin, warfarin, or Novel Oral Anticoagulant (NOAC) Contraindication to iodinated contrast product XENETIX® (iobitridol hypersensitivity or at one of these excipients, history of major immediate reaction or cutaneous reaction to XENETIX® infusion, thyrotoxicosis) Hypersensitivity to ethanol Unstable angina or ongoing myocardial ischemia Myocardial infarction within 3 months prior to inclusion Congenital heart disease, where the underlying abnormality increases the ablation risk Pulmonary hypertension (pulmonary arterial hypertension > 50 mmHg) Severe uncontrolled systemic hypertension with systolic blood pressure (SBP) > 200 mm Hg within 30 days prior to inclusion Severe bleeding, clotting or thrombotic disorder Left atrial diameter > 60 mm (parasternal view) Hypertrophic cardiomyopathy defined by a left ventricular septum thickness > 1.5 cm Pregnant, parturient or nursing women Unable or unwilling to provide written informed consent Patient detained by judicial or administrative order Patient under psychiatric care Patient admitted in a social or healthcare establishment for any purpose other than the research Subject to a legal protection order (guardianship, patient under legal protection)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas DERVAL, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bordeaux University Hospital
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19756206
Citation
Valderrabano M, Chen HR, Sidhu J, Rao L, Ling Y, Khoury DS. Retrograde ethanol infusion in the vein of Marshall: regional left atrial ablation, vagal denervation and feasibility in humans. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):50-6. doi: 10.1161/CIRCEP.108.818427.
Results Reference
result

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MARSHALL PLAN Vs. Pulmonary Veins Isolation Monocentric Trial

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