Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation: A Safety and Feasibility Study

NCT02028130 | Unknown

• 2 other identifiers: 2012CI004B, 12/LO/080994318
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) affects as many as 1 in 16 people over the age of 65 and reduces the quality of life of large numbers of people in the UK and around the world. Catheter ablation is a minimally invasive treatment that has been developed to help eliminate AF. Recent studies have identified that a particular area of the heart, namely the left atrial appendage (LAA), which is a pouch in the left atrium (small collecting chamber of the heart), may be the main source of AF in many cases. There is a clear lack of knowledge about the structure, anatomy, function and electrical properties of the LAA, which is fundamental to furthering our understanding and management of AF. In addition, it is well known that AF significantly increases the risk of stroke. The majority of strokes occur due to blood clots forming in the LAA. Traditionally, the most effective treatment to minimise the risk of stroke has been to thin the blood with agents such as warfarin. This therapy requires regular blood tests at much inconvenience to patients and increases the risk of bleeding complications. Recently, a large study demonstrated that use of an implanted device (Watchman®) to occlude the LAA is as effective as warfarin in preventing stroke and confers a lower mortality rate. We aim to investigate whether it is safe and feasible to ablate the LAA and to implant a Watchman® device during the same procedure in patients who are in atrial fibrillation all of the time.

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial fibrillation; Ablation; Left atrial appendage occlusion; Stroke prevention

Outcome Measures

Primary Outcomes (2)

• Feasibility of concomitant LAA electrical isolation and percutaneous left atrial appendage occlusion using Watchman® device in patients with persistent atrial fibrillation

  Success rates of LAA electrical isolation and Watchman® device implantation post-LAA isolation will be determined during index procedures

  At time of procedure

• Freedom from serious adverse events (stroke, myocardial infarction, emergency surgery, death) immediately after the procedure and during follow-up

  Serious adverse event rate will be determined immediately after the procedure and during the 6 month follow-up period

  Immediately after the procedure and at 6 months

Study Arms (1)

LAA electrical isolation + occlusion

EXPERIMENTAL

Standard persistent AF ablation protocol + LAA electrical isolation + Watchman device implantation to occlude LAA

Procedure: LAA electrical isolation + occlusion

Interventions

LAA electrical isolation + occlusion PROCEDURE

LAA electrical isolation + Watchman device implantation to occlude LAA

LAA electrical isolation + occlusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 80 years
• Symptomatic, documented AF lasting for at least 7 days (persistent or permanent AF) refractory to at least 1 AAD and/or DCCV
• Long-term indication to continue warfarin

You may not qualify if:

• Previous ablation procedure
• Pregnancy
• Prior AV nodal ablation or complete heart block (CHB) with a permanent pacemaker (PPM)
• Contraindication to anticoagulation
• Persistent thrombus in the left atrium despite anticoagulation
• Active malignancy
• Expected life expectancy \< 6 months
• Cerebrovascular accident within the previous 6 months
• Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
• Cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), valve or coronary bypass surgery within the previous 3 months
• Prior left atrial catheter ablation with the intention to treat AF
• Prior surgical interventions for AF such as the MAZE procedure
• Previous heart transplant
• Severe neuro-muscular disease
• Creatinine clearance \<30 ml/min (estimated GFR)

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton & Harefield NHS Foundation Trust

London, Greater London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• Panikker S, Jarman JW, Virmani R, Kutys R, Haldar S, Lim E, Butcher C, Khan H, Mantziari L, Nicol E, Foran JP, Markides V, Wong T. Left Atrial Appendage Electrical Isolation and Concomitant Device Occlusion to Treat Persistent Atrial Fibrillation: A First-in-Human Safety, Feasibility, and Efficacy Study. Circ Arrhythm Electrophysiol. 2016 Jul;9(7):e003710. doi: 10.1161/CIRCEP.115.003710.

  PMID: 27406602 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Salicylic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Tom Wong, MD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 6, 2014
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 3, 2014

Record last verified: 2014-06

Locations

GB (1)