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

Paroxysmal Atrial Fibrillation Clinical Trial

— LOCALIZE CF  

Official title:

Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology In The Treatment of Paroxysmal Atrial Fibrillation: A Non-Randomized Prospective Study With Contact Force

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740801
• Other study ID #: PM011
• Status: Completed
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: September 16, 2022

Study information

• Verified date: May 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 16, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Ablation procedure
Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav StablePoint ablation catheter

Locations

Country	Name	City	State
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Städtisches Klinikum Karlsruhe	Karlsruhe
Italy	Casa di Cura Montevergine S.p.A.	Mercogliano	Avellino
Italy	Centro Cardiologico Monzino	Milano
Spain	Clinica Universidad de Navarra	Pamplona

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between Local Impedance drop values and PV reconnections	Correlation between local impedance drop collected during the blinded index procedure and sites of late PV reconnection/durable block at 3-months.	0-3 months
Secondary	Association between Local Impedance drop values and acute PV reconnections	Correlation between local impedance drop collected during the blinded index procedure and sites of acute gaps/block after a 20-minute wait period.	0-1 month