Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

NCT04580914 | Completed Results DMC FDA Device

• 1 other identifier: 92567361
• Study Type: interventional
• Target: 321
• Locations: 13 countries
• Sites: 47

Brief Summary

The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Atrial Fibrillation; StablePoint; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

• Rate of Primary Safety Events at 1-Month Post-Procedure

  The primary safety endpoint at 30 days is defined as the safety event-free rate at 1-Month (30 days) post-procedure.

  Up to 30 Days

• Rate of Primary Safety Events at 12-Months Post-Procedure

  The primary safety endpoint at 12 months is defined as the safety event-free rate at 12 months post-procedure.

  12 Months

• Percentage of Participants With Freedom From Treatment Failure at 12-Months Post-Procedure

  The twelve-month effectiveness endpoint is defined as the event-free rate at twelve-month post-procedure.

  12 Months

• Number of Participants That Achieved Electrical Isolation of All Pulmonary Veins

  The primary effectiveness endpoint of acute procedural success is defined as the achievement of electrical isolation of all PVs using the IntellaNav StablePoint catheter only.

  30 Days

Secondary Outcomes (5)

• Rate of AEs Through 12-Months Post-Procedure

  12 Months

• Number of Patients With New or Increased Dose of AAD

  12 Months

• Percentage of Participants With Freedom From Primary Effectiveness Failure Without a Repeat Procedure

  12 Months

• Percentage of Participants With Freedom From Documented Symptomatic Atrial Fibrillation, Atrial Flutter and Atrial Tachycardia Recurrence

  12 Months

• Rate of SAEs Through 12-Months Post-Procedure

  12 Months

Study Arms (1)

Treatment with Ablation Catheter

EXPERIMENTAL

Patients who undergo treatment with the ablation catheter for the treatment of paroxysmal atrial fibrillation

Device: Treatment with IntellaNav StablePoint Ablation Catheter

Interventions

Treatment with IntellaNav StablePoint Ablation Catheter DEVICE

Patients will be treated with an ablation catheter

Also known as: IntellaNav StablePoint Catheter System

Treatment with Ablation Catheter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the following:
• a physician's note indicating recurrent self-terminating atrial fibrillation (AF) which includes at least two symptomatic AF episodes in the patient's history within the last 6 months prior to enrollment, and any electrocardiographically documented AF episode within 12 months prior to enrollment.
• Subjects who are eligible for an ablation procedure for PAF according to 2017 HRS expert consensus statement on catheter ablation of atrial fibrillation;
• Subjects refractory or intolerant to at least one class I or class III antiarrhythmic medication or contraindicated to any class I or class III medications;
• Subjects who are willing and capable of providing informed consent;
• Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
• Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

You may not qualify if:

• Subjects with New York Heart Association (NYHA) Class III or IV heart failure \< 180 days prior to enrollment
• Left atrial diameter \> 5.0 cm or left atrial volume \>50 ml/m² indexed based on the most recent echocardiography+
• Left ventricular ejection fraction \< 35% based on the most recent echocardiogram +
• Continuous AF lasting longer than seven (7) days
• Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical)
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Subjects who have undergone any cardiac ablation or any surgery within 30 days prior to enrollment
• Currently implanted with a pacemaker, ICD, CRT device, or an implanted arrhythmia loop recorder
• Active systemic infection
• Unstable angina or ongoing myocardial ischemia
• Myocardial Infarction (MI) within 90 days prior to enrollment
• Evidence of myxoma, left atrial thrombus or intracardiac mural thrombus++
• Previous cardiac surgery (i.e. ventriculotomy, atriotomy, CABG, PTCA, PCI, coronary stenting procedures) ≤ 90 days prior to enrollment.
• Severe valvular disease, including mechanical prosthetic mitral or tricuspid heart valves (patients with successful mitral valve repair allowed - annular ring constitutes repair);
• Any prior history of documented cerebral infarct, TIA or systemic embolism \[excluding a post-operative deep vein thrombosis (DVT)\] \<180 days prior to enrollment

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (47)

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

St. Lukes Idaho Cardiology Associates

Boise, Idaho, 83712, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

St. John's Hospital

Springfield, Illinois, 62769, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Mercy Hospital Medical Center

West Des Moines, Iowa, 50266, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Michigan Hospitals

Ann Arbor, Michigan, 48109, United States

Location

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota, 55805, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Northwell Health

Bay Shore, New York, 11706, United States

Location

Weill Cornell Medical University

New York, New York, 10021, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157-1023, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Bryn Mawr Medical Specialists

Bryn Mawr, Pennsylvania, 19146, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8802, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Orion Medical

Pasadena, Texas, 77505, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75702, United States

Location

Chippenham and Johnston-Willis Hospital (CJW)

Richmond, Virginia, 23225, United States

Location

A.o. Krankenhaus der Elisabethinen Linz

Linz, 4020, Austria

Location

Allgemeines Krankenhaus AKH

Vienna, 1190, Austria

Location

Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, Belgium

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1L8, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Institut universitaire de Cardiologie et de Pneumologie de Quebec

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Hospital de la Pitie-Salpetriere

Paris, 75013, France

Location

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Bernau, 16321, Germany

Location

Queen Elizabeth Hospital

Kowloon, Hong Kong

Location

Prince of Wales Hospital

Shatin, 999077, Hong Kong

Location

Az. Osp. Lancisi

Ancona, AN, 60126, Italy

Location

Fondazione Centro San Raffaele

Milan, 20132, Italy

Location

Kokura Memorial Hospital

Fukuoka-ken, 802-8555, Japan

Location

Yokosuka Kyosai Hospital

Kanagawa, 238-8558, Japan

Location

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

Medisch Spectrum Twente

Amsterdam, 1105 AZ, Netherlands

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Papworth Hospital

Cambridge, CB2 0AY, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Claire Dietzsch, Senior Clinical Trials Specialist
• Organization: Boston Scientific

Claire.Dietzsch@bsci.com

9529306745

Study Officials

• Gregory Michaud

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 9, 2020
• Study Start: April 12, 2021
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1); NL (1); AU (2); TW (3); GB (3); CA (3); JP (2); US (25); BE (1); FR (1); DE (1); HK (2); IT (2)