Trial record 2 of 14 for:    contact AFL

TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Continued Access Protocol

This study is currently recruiting participants.
Verified March 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT02088606
First received: March 12, 2014
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.


Condition Intervention
Paroxysmal Atrial Fibrillation
Device: TactiCath Quartz treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Electrical isolation of all 4 PVs, or in the event of a common PV, the clinical equivalent of all PVs, by the end of index procedure [ Time Frame: 30 min post ablation ] [ Designated as safety issue: No ]
  • Acute procedural success and freedom from recurrence of symptomatic AF, AFL, and AT lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period. Re-treatment for AF with ablation after 3 months is a failure [ Time Frame: 12 months post ablation ] [ Designated as safety issue: No ]
  • Device-related early onset primary SAEs occurring within 7 days of the index procedure [ Time Frame: 7 days post ablation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: March 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TactiCath Quartz
TactiCath Quartz treatment
Device: TactiCath Quartz treatment
Catheter ablation for the treatment of paroxysmal atrial fibrillation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptomatic PAF (Paroxysmal Atrial Fibrillation)refractory to at least one Class I-IV antiarrhythmic drug
  • minimum one documented PAF episode >30 sec duration within prior 12 months
  • minimum three PAF episodes during prior 12 months
  • 18 years or older

Exclusion Criteria:

  • persistent or long-standing persistent AF(Atrial Fibrillation)
  • four or more cardioversions in prior 12 months
  • MI (myocardial infarction), CABG (coronary artery bypass graft) or PCI (percutaneous coronary intervention) within preceding 3 months
  • left atrial diameter > 5.0 cm
  • LVEF (left ventricular ejection fraction)< 35%
  • NYHA (New York Heart Association) class III or IV
  • previous left atrial ablation procedure
  • previous tricuspid or mitral valve repair surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02088606

Contacts
Contact: Nicole Glowacki 6517563432 nglowacki@sjm.com

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sabina Sayeed       ssayeed@partners.org   
Principal Investigator: Moussa Mansour, MD         
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02088606     History of Changes
Other Study ID Numbers: VP-002 527 Version H
Study First Received: March 12, 2014
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014