Ablation of the Pulmonary Veins for Paroxysmal Afib

NCT00744874 | Completed Phase 4 Results

• 1 other identifier: AFI-40
• Study Type: interventional
• Target: 55
• Locations: 4 countries
• Sites: 5

Brief Summary

The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal atrial fibrillation. (PAF)

Conditions

Paroxysmal Atrial Fibrillation

Keywords

atrial fibrillation

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Successful Pulmonary Vein Isolation

  Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.

  6 months

• Chronic Effectiveness

  The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months.

  6 months

• Acute Safety

  The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site.

  7 days post procedure

• Chronic Safety

  The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.

  7 day post procedure to 6 months

Secondary Outcomes (5)

• Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months

  6 Months

• The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline

  6 months

• Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins

  After Procedure

• Total Procedure Time

  End of Procedure

• Total Fluoroscopy Time

  Post Ablation Procedure

Study Arms (1)

Ablated Patients

EXPERIMENTAL

Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.

Procedure: RF Ablation procedure

Interventions

RF Ablation procedure PROCEDURE

Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.

Also known as: Radio Frequency Ablation

Ablated Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of symptomatic paroxysmal atrial fibrillation defined as:
• Self terminating AF lasting no more than 7 days
• AF events demostrating spontaneous conversion back to sinus rhythm
• Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year
• AF symptoms defined as the manisfestation of any of the following: Palpitations, Fatigue, Exertional dyspnea, effort intolerance
• Age between 18 and 70
• Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study

You may not qualify if:

• Structural heart disease of clinical significance
• Prior ablation for arrhythmias other than AF within the past three months
• Prior left sided AF ablation
• Enrollment in any other ongoing arrhythmia study protocol
• Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
• Active infection or sepsis
• Any history of cerebral vascular disease including stroke or TIAs
• Pregnancy or lactation
• Untreatable allergy to contrast media
• Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
• History of blood clotting (bleeding or thrombotic) abnormalities
• Known sensitivities to heparin or warfarin
• Severe COPD (identified by an FEV1 \< 1)
• Severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (5)

Rigshospitalet

Copenhagen, Denmark

Location

Hjertecenter Varde

Varde, Denmark

Location

Zentralklinik

Bad Berka, Germany

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Klinik im Park

Zurich, Switzerland

Location

Related Links

• Company website

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Linda Nelson, RN, BSN, MBA- AF Solutions Clinical Operations Director
• Organization: Medtronic AF Solutions

linda.k.nelson@medtronic.com

(763)526-2891

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: September 1, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: July 1, 2011
• Last Updated: September 19, 2018
• Results First Posted: January 18, 2013

Record last verified: 2018-09

Locations

NL (1); DK (2); CH (1); DE (1)