Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology In The Treatment of Paroxysmal Atrial Fibrillation (LOCALIZE CF)

NCT ID: NCT04740801

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2022-09-16

Brief Summary

The objective of this study is to evaluate whether local impedance (DIRECTSENSE™) drop on the INTELLANAV STABLEPOINT™ ablation catheter is associated with late pulmonary vein (PV) reconnections and durable conduction block in patients undergoing de novo PV isolation (PVI) for treatment of paroxysmal atrial fibrillation (PAF).

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PVI procedure

Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form. For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 4.0.1 or greater (commercially approved version) with DIRECTSENSE™ and Force Computation Software Module; the IntellaMap Orion mapping catheter and the IntellaNav StablePoint ablation catheter.

Group Type: OTHER

Ablation procedure

Intervention Type: DEVICE

Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav StablePoint ablation catheter

Interventions

Ablation procedure

Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav StablePoint ablation catheter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. History of recurrent, symptomatic, paroxysmal atrial fibrillation (PAF), defined as atrial fibrillation (AF) that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes at least one AF episode electrocardiographically documented and at least one additional symptomatic recurrence with or without electrocardiographic documentation, within 365 days prior to enrollment.

2. Subjects who are eligible for an ablation procedure for paroxysmal AF according to international and local guidelines on catheter ablation of AF.

3. Subjects refractory or intolerant to at least one Beta Blocker, Calcium Channel Blocker, class I or III antiarrhythmic medication taken for the treatment of AF/AT (Atrial Tachycardia)/AFL (Atrial Flutter) or contraindicated to any class I or III antiarrhythmic medications, Beta Blocker or Calcium Channel Blocker.

4. Subjects who are willing and capable of providing informed consent.

5. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center.

6. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to local and national law.

Exclusion Criteria

1. Any known contraindication to an AF ablation or anticoagulation

2. Continuous AF lasting longer than seven days from onset (no episodes within 365 days from enrollment)

3. History of previous LA ablation or surgical treatment for AF/AT/AFL

4. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause

5. Subjects with life expectancy ≤ 6 months

6. Structural heart disease, heart conditions, or implanted devices as described below:

1. Left ventricular ejection fraction < 35% based on the most recent imaging (≤ 180 days prior to enrollment)*

2. LA diameter > 5.5 cm or LA volume >50 ml/m² indexed based on the most recent imaging (≤ 180 days prior to enrollment)*

3. Heart failure with New York Heart Association (NYHA) Class III or IV

4. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, stent procedure) within 90 days prior to enrollment

5. Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days prior to enrollment

6. Severe valvular disease or presence of a prosthetic - mechanical or biological - heart valve in the LA (not including valve repair and annular rings)

7. Severe mitral valve regurgitation or stenosis

8. Known or pre-existing severe pulmonary vein stenosis

9. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder

10. Presence of LA appendage occlusion device

11. Presence of any pulmonary vein stents

12. Unstable angina or ongoing myocardial ischemia

13. Previous myocardial infarction within 90 days prior to enrollment

14. Vena cava embolic protection filter devices and/or known femoral thrombus;

15. Known left atrial thrombus, myxoma, or intracardiac mural thrombus

7. History of blood clotting or bleeding disease

8. Any prior history of documented cerebral infarct, TIA, or systemic embolism [excluding a post-operative deep vein thrombosis (DVT)] ≤180 days prior to enrollment

9. Active systemic infection

10. Pregnant, lactating (current or anticipated during study follow up), or women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)

11. Subjects who are currently enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries, without written approval from the sponsor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ignacio Garcia Bolao, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Universitaria de Navarra

Hüseyin Ince, MD

Role: PRINCIPAL_INVESTIGATOR

Vivantes Klinikum am Urban

Francesco Solimene, MD

Role: PRINCIPAL_INVESTIGATOR

Casa Di Cura 'Montevergine' S.P.A.

Armin Luik, MD

Role: PRINCIPAL_INVESTIGATOR

Staedtisches Klinikum Karlsruhe

Locations

Vivantes Klinikum Am Urban

Berlin, , Germany

Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Casa di Cura Montevergine S.p.A.

Mercogliano, Avellino, Italy

Centro Cardiologico Monzino

Milan, , Italy

Clinica Universidad de Navarra

Pamplona, , Spain

Countries

Germany; Italy; Spain

Other Identifiers

PM011

Identifier Type: -

Identifier Source: org_study_id