Esophageal Deviation in Atrial Fibrillation Ablation

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03261973
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arm: 1
• Actual Duration (Months): 30.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy employed for the treatment of atrial fibrillation (AF). However, ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. Thermal injury is very common and occurs in up to 40% of AF ablations per some studies. When significant thermal injury to the esophagus occurs, two significant complications can arise: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the occurrence of fistula is rare, it is a very important complication since it is often fatal. Currently luminal esophageal temperature monitoring is the most commonly employed modality to prevent such injury. However, there are limitations to its use, and atrio-esophageal fistulas continue to be a major problem in AF ablation even when using esophageal temperature monitoring. Esophageal deviation using either a Transesophageal echocardiogram (TEE) or Esophagogastroduodenoscopy (EGD) probe has been described in the literature, but the effectiveness and practicality of these techniques are suboptimal, and have therefore precluded their use in routine clinical practice. Recently, esophageal deviation using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) was tested in the randomized double-blind multicenter study "Deviating the Esophagus in Atrial Fibrillation Ablation (DEVIATE-AF)". In that study the standard practice (i.e., use of luminal esophageal temperature monitoring) was compared to esophageal deviation using off-the-shelf equipment. The results were very encouraging showing that esophageal deviation allowed for significant reductions in esophageal temperature and proportion of premature ablation terminations. Importantly, esophageal deviation allowed the isolation all PVs in the treatment group, which was not the case in the control group. One major limitation in the DEVIATE-AF trial was that off-the-shelf equipment tool was challenging to use. The aim of the Esophageal Deviation in Atrial Fibrillation Ablation study is to test the feasibility and safety of moving the esophagus using a specialized esophageal deviation tool (DV8, Manual Surgical Sciences, Minneapolis, MN).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: DV8	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Esophageal Deviation in Atrial Fibrillation Ablation
• Actual Study Start Date: Nov 17, 2017
• Actual Primary Completion Date: Jun 15, 2020
• Actual Study Completion Date: Jun 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: DV8 esophageal deviation tool This is a non-randomized one arm study.	Device: DV8; DV8 esophageal deviation tool

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Minimum Distance of 1 cm Esophageal Deviation Between the Ablation Line for the Ipsilateral Pulmonary Vein (PV) Pairs and the Trailing Edge of the Esophagus. [during Atrial Fibrillation (AF) ablation procedure (intraoperative)]

Secondary Outcome Measures

1. Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs. [during AF ablation procedure]

2. Number of Participants Who Experienced Esophageal Laceration [within 1-90 days of the procedure]

3. Number of Participants With PV Reconnection Assessed by Adenosine Infusion [during AF ablation procedure]

4. Fluoroscopy Time Measured for the Whole Procedure [during AF ablation procedure]

5. Procedure Duration Measured From the Initial Groin Stick to Catheter Removal [during the AF ablation procedure]

6. Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery [during the AF ablation procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

INCLUSION CRITERIA

• A maximum of up to 54 patients will be enrolled in this prospective single-center single-arm study. Patients undergoing AF ablation (including paroxysmal and persistent AF) will be included in this study. Consistent with the current definitions, paroxysmal AF are episodes that will self-terminate in less than 24 hours. Persistent AF, is defined as ≥1 documented AF lasting >1week in duration or lasting less than 7 days but requiring electrical or pharmacological cardioversion to sinus rhythm.

• Age >18 - Age < 80 yr

• Documentation of atrial fibrillation (AF)

• General anesthesia

• All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.

EXCLUSION CRITERIA

• Any reversible cause of AF (post-surgery, thyroid disorder, etc.)

• INR (international normalized ratio) > 4.0 at the time of the procedure

• History of (H/o) of severe esophageal ulcers, strictures, varices, bleeding, laceration or perforation, esophagitis

• Severe Gastroesophageal Reflux Disease (GERD)

• H/o esophageal surgery or any esophageal banding or cautery

• H/o chest radiation

• Significant abnormality on Swallowing Impairment Score

• Mental impairment precluding signing consent or completing follow up

• Patients with any other significant uncontrolled or unstable medical condition

• Women who are known to be pregnant or have had a positive β-HCG (Human Chorionic Gonadotropin) test within 7 days prior to procedure

• Presence of left atrial thrombus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 18, 2019

More Information

Publications

None provided.

• Responsible Party: Moussa C Mansour, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03261973
• Other Study ID Numbers: 2017P001544
• First Posted: Aug 25, 2017
• Last Update Posted: Jun 30, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Arm/Group Title	DV8 Esophageal Deviation Tool
Arm/Group Description	This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Period Title: Overall Study
STARTED	47
COMPLETED	43
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	DV8 Esophageal Deviation Tool
Arm/Group Description	This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Overall Participants	43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.9 (9.1)
Sex: Female, Male (Count of Participants)
Female	12 27.9%
Male	31 72.1%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Minimum Distance of 1 cm Esophageal Deviation Between the Ablation Line for the Ipsilateral Pulmonary Vein (PV) Pairs and the Trailing Edge of the Esophagus.
Time Frame	during Atrial Fibrillation (AF) ablation procedure (intraoperative)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DV8 Esophageal Deviation Tool
Arm/Group Description	This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Measure Participants	43
Count of Participants [Participants]	42 97.7%

2. Secondary Outcome

Title	Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs.
Time Frame	during AF ablation procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DV8 Esophageal Deviation Tool
Arm/Group Description	This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Measure Participants	43
Count of Participants [Participants]	9 20.9%

3. Secondary Outcome

Title	Number of Participants Who Experienced Esophageal Laceration
Time Frame	within 1-90 days of the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DV8 Esophageal Deviation Tool
Arm/Group Description	This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Measure Participants	43
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Number of Participants With PV Reconnection Assessed by Adenosine Infusion
Time Frame	during AF ablation procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DV8 Esophageal Deviation Tool
Arm/Group Description	This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Measure Participants	43
Count of Participants [Participants]	10 23.3%

5. Secondary Outcome

Title	Fluoroscopy Time Measured for the Whole Procedure
Time Frame	during AF ablation procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DV8 Esophageal Deviation Tool
Arm/Group Description	This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Measure Participants	43
Mean (Standard Deviation) [minutes]	23.8 (8.1)

6. Secondary Outcome

Title	Procedure Duration Measured From the Initial Groin Stick to Catheter Removal
Time Frame	during the AF ablation procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DV8 Esophageal Deviation Tool
Arm/Group Description	This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Measure Participants	43
Mean (Standard Deviation) [minutes]	212 (32)

7. Secondary Outcome

Title	Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery
Time Frame	during the AF ablation procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DV8 Esophageal Deviation Tool
Arm/Group Description	This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
Measure Participants	43
Mean (Standard Deviation) [minutes]	53.2 (16.2)

Adverse Events

Time Frame	The duration of the study was 3 months
Arm/Group Title	DV8 Esophageal Deviation Tool
Arm/Group Description	This is a non-randomized one arm study. Arm: usage of the DV8 esophageal deviation tool during the ablation procedure
All Cause Mortality
	DV8 Esophageal Deviation Tool
	Affected / at Risk (%)	# Events
Total	0/43 (0%)
Serious Adverse Events
	DV8 Esophageal Deviation Tool
	Affected / at Risk (%)	# Events
Total	0/43 (0%)
Other (Not Including Serious) Adverse Events
	DV8 Esophageal Deviation Tool
	Affected / at Risk (%)	# Events
Total	2/43 (4.7%)
Cardiac disorders
Pericarditis	1/43 (2.3%)
Gastrointestinal disorders
Gastroparesis	1/43 (2.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.